On May 17, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that more than 80 presentations, including 16 oral presentations and seven poster discussions, highlighting data from Company-sponsored studies, collaborations and investigator-sponsored research evaluating its oncology compounds across 20 types of cancer, will be featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2017 in Chicago from June 2-6 (Press release, Bristol-Myers Squibb, MAY 17, 2017, View Source [SID1234519196]).

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Results to be presented represent the breadth of the Company’s Oncology research portfolio, including monotherapy and combination studies of Opdivo (nivolumab) and Yervoy (ipilimumab), as well as studies of Empliciti (elotuzumab) and Sprycel (dasatinib). The Company will also present updates from its robust investigational pipeline, including proof-of-concept efficacy data for its anti-lymphocyte activation gene-3 (LAG-3) monoclonal antibody in combination with Opdivo and pharmacokinetic, pharmacodynamic and safety data on its investigational glucocorticoid-induced tumor necrosis factor receptor-related gene (GITR) agonist alone and for the first time, in combination with Opdivo in advanced solid tumors.

Several presentations will report data from clinical collaborations supportive of the Company’s efforts to advance understanding of the potential role for Opdivo in combination with novel mechanisms of action for several tumor types, including the first presentation of data evaluating the safety and efficacy of Opdivo in combination with epacadostat, Incyte’s selective IDO1 enzyme inhibitor. Presentations featuring translational medicine research underscore Bristol-Myers Squibb’s scientific leadership in driving understanding of how a patient’s tumor biology can potentially guide treatment decisions.

Data from research on the Company’s medicines to be presented during the meeting include:

Gastrointestinal Malignancies

Combination of nivolumab + ipilimumab in the treatment of patients with deficient DNA mismatch repair/high microsatellite instability metastatic colorectal cancer: CheckMate 142 study
Author: Thierry Andre
Abstract #3531
Poster Session: Gastrointestinal (Colorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A

Concordance of DNA mismatch repair deficient/microsatellite instability assessment by local and central testing in patients with metastatic CRC receiving nivolumab in CheckMate 142
Author: Scott Kopetz
Abstract #3548
Poster Session: Gastrointestinal (Colorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A

Nivolumab in sorafenib-naive and -experienced patients with advanced hepatocellular carcinoma: The CheckMate 040 study
Author: Todd S. Crocenzi
Abstract #4013
Poster Discussion Session: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A
Discussed at the Poster Discussion Session on Saturday, June 3, 2017, 4:45–6:00 PM, Hall D2

CheckMate 577: A randomized, double-blind, phase 3 study of adjuvant nivolumab or placebo in patients with resected esophageal or gastroesophageal junction cancer
Author: Ronan Joseph Kelly
Abstract #TPS4131
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A

CheckMate 649: A randomized, multicenter, open-label, phase 3 study of nivolumab + ipilimumab or nivo + chemotherapy vs CTX alone in patients with previously untreated advanced gastric or gastroesophageal junction cancer
Author: Markus H. Moehler
Abstract #TPS4132
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A

Nivolumab ± ipilimumab in patients with advanced/metastatic chemotherapy-refractory gastric, esophageal or gastroesophageal junction cancer: CheckMate 032 study
Author: Yelena Yuriy Janjigian
Abstract #4014
Oral Abstract Session: Gastrointestinal (Noncolorectal) Cancer
Sunday, June 4, 9:24–9:36 AM, Hall D2

Genitourinary Cancer

Health-related quality of life as a marker of treatment benefit with nivolumab in platinum-refractory patients with metastatic or unresectable urothelial carcinoma from CheckMate 275
Author: Andrea Necchi
Abstract #4526
Poster Session: Genitourinary (Nonprostate) Cancer
Sunday, June 4, 8:00–11:30 AM, Hall A

Glioblastoma

Histopathologic review of suspected disease progression in patients with recurrent glioblastoma receiving nivolumab ± ipilimumab: CheckMate 143
Author: Solmaz Sahebjam
Abstract #2001
Oral Abstract Session: Central Nervous System Tumors
Sunday, June 4, 8:12–8:24 AM, S100a

Overall survival by line of therapy in Medicare-enrolled glioblastoma multiforme patients
Author: Abdalla Aly
Abstract #2039
Poster Session: Central Nervous System Tumors
Monday, June 5, 1:15–4:45 PM, Hall A

Gynecologic Cancers

An open-label, multicohort, phase 1/2 study of nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic cervical, vaginal and vulvar cancers
Author: Antoine Hollebecque
Abstract #5504
Oral Abstract Session: Gynecologic Cancer
Friday, June 2, 4:12–4:24 PM, S406

Head and Neck Cancer

Nivolumab vs investigator’s choice for platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (Checkmate 141): Outcomes in first-line R/M patients and updated safety and efficacy
Author: Maura L. Gillison
Abstract #6019
Poster Discussion Session: Head and Neck Cancer
Monday, June 5, 1:15–4:45 PM, Hall A
Discussed at the Poster Discussion Session on Monday, June 5, 2017, 4:45–6:00 PM, S406

Nivolumab vs investigator’s choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by prior cetuximab use
Author: Robert L. Ferris
Abstract #6020
Poster Discussion Session: Head and Neck Cancer
Monday, June 5, 1:15–4:45 PM, Hall A
Discussed at the Poster Discussion Session on Monday, June 5, 2017, 4:45–6:00 PM, S406

An open-label, multicohort, phase 1/2 study to evaluate nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic nasopharyngeal carcinoma
Author: Jean-Pierre Delord
Abstract #6025
Poster Session: Head and Neck Cancer
Monday, June 5, 1:15–4:45 PM, Hall A

Characterization of potential predictive biomarkers of response to nivolumab in CheckMate 141 in patients with squamous cell carcinoma of the head and neck
Author: Fernando Concha-Benavente
Abstract #6050
Poster Session: Head and Neck Cancer
Monday, June 5, 1:15–4:45 PM, Hall A

Hematologic Malignancies

Phase 2 trial of dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase
Author: Lia Gore
Abstract #10511
Oral Abstract Session: Pediatric Oncology II
Monday, June 5, 8:24–8:36 AM, S504

Impact of dose reductions on 5-year efficacy in newly diagnosed patients with chronic myeloid leukemia in chronic phase from DASISION
Author: Jorge E. Cortes
Abstract #7051
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Monday, June 5, 8:00–11:30 AM, Hall A

Phase 3 ELOQUENT-2 study: Extended four-year follow-up of elotuzumab plus lenalidomide/dexamethasone vs Ld in relapsed/refractory multiple myeloma
Author: Sagar Lonial
Abstract #8028
Poster Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Monday, June 5, 8:00–11:30 AM, Hall A

Nivolumab in combination with daratumumab, with or without pomalidomide and dexamethasone, for relapsed/refractory multiple myeloma: 2 cohorts of the phase 1 CheckMate 039 safety study
Author: Alexander M. Lesokhin
Abstract #TPS3102
Poster Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 8:00–11:30 AM, Hall A

CheckMate 436: A phase 1/2 study to evaluate safety and efficacy of nivolumab plus brentuximab vedotin in patients with CD30-expressing relapsed/refractory non-Hodgkin lymphomas
Author: Paul M. Barr
Abstract #TPS7577
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 5, 8:00–11:30 AM, Hall A
CheckMate 602: An open-label, randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide and dexamethasone in relapsed/refractory multiple myeloma
Author: Sagar Lonial
Abstract #TPS8052
Poster Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Monday, June 5, 8:00–11:30 AM, Hall A

Melanoma

Overall survival analysis from an expanded access program of nivolumab in combination with ipilimumab in patients with advanced melanoma (CheckMate 218)
Author: David Hogg
Abstract #9522
Poster Session: Melanoma/Skin Cancers
Saturday, June 3, 1:15–4:45 PM, Hall A

Association of distinct baseline tissue biomarkers with response to nivolumab and ipilimumab in melanoma: CheckMate 064
Author: Scott Rodig
Abstract #9515
Poster Discussion Session: Melanoma/Skin Cancers
Saturday, June 3, 1:15–4:45 PM, Hall A
Discussed at the Poster Discussion Session on Saturday, June 3, 2017, 4:45–6:00 PM, E354b

Management of gastrointestinal toxicity associated with nivolumab plus ipilimumab (IPI) or IPI alone in phase 2 and 3 trials in advanced melanoma
Author: Jeffrey S. Weber
Abstract #9523
Poster Session: Melanoma/Skin Cancers
Saturday, June 3, 1:15–4:45 PM, Hall A

Efficacy and safety of nivolumab in patients with advanced melanoma and poor prognostic factors who progressed on or after ipilimumab: Results from a phase 2 study (CheckMate 172)
Author: Dirk Schadendorf
Abstract #9524
Poster Session: Melanoma/Skin Cancers
Saturday, June 3, 1:15–4:45 PM, Hall A

Efficacy and safety of nivolumab plus ipilimumab in patients with melanoma metastatic to the brain: Results of the phase 2 study CheckMate 204
Author: Hussein Abdul-Hassan Tawbi
Abstract #9507
Oral Abstract Session: Melanoma/Skin Cancers
Sunday, June 4, 10:12–10:24 AM, Arie Crown Theater

Thoracic Malignancies

Nivolumab plus ipilimumab as first-line treatment for advanced NSCLC: 2-year OS and long-term outcomes from CheckMate 012
Author: Jonathan Wade Goldman
Abstract #9093
Poster Session: Lung Cancer—Non-Small Cell Metastatic
Saturday, June 3, 8:00–11:30 AM, Hall A

Checkmate 816: A phase 3, randomized, open-label trial of nivolumab plus ipilimumab vs platinum-doublet chemotherapy as neoadjuvant treatment for early-stage NSCLC
Author: Patrick M. Forde
Abstract #TPS8577
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Saturday, June 3, 8:00–11:30 AM, Hall A

Checkmate 743: A phase 3, randomized, open-label trial of nivolumab plus ipilimumab vs pemetrexed plus cisplatin or carboplatin as first-line therapy in unresectable pleural mesothelioma
Author: Gerard Zalcman
Abstract #TPS8581
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Saturday, June 3, 8:00–11:30 AM, Hall A

Nivolumab ± ipilimumab in advanced small cell lung cancer: first report of a randomized expansion cohort from CheckMate 032
Author: Matthew David Hellmann
Abstract #8503
Oral Abstract Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Monday, June 5, 9:00–9:12 AM, Hall B1

Pipeline

FRACTION (Fast Real-time Assessment of Combination Therapies in Immuno-ONcology)-gastric cancer (GC): A randomized, open-label, adaptive phase 2 study of nivolumab in combination with other immuno-oncology agents in patients with advanced GC
Author: Praveen Aanur
Abstract #TPS4137
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 3, 8:00–11:30 AM, Hall A
Initial efficacy of anti-lymphocyte activation gene-3 (anti–LAG-3; BMS-986016) in combination with nivolumab in patients with melanoma previously treated with anti–PD-1/PD-L1 therapy
Author: Paolo Antonio Ascierto
Abstract #9520
Poster Discussion Session: Melanoma/Skin Cancers
Saturday, June 3, 1:15–4:45 PM, Hall A
Discussed at the Poster Discussion Session on Saturday, June 3, 2017, 4:45–6:00 PM, E354b
Preliminary results of a phase 1/2a study of BMS-986156 (glucocorticoid-induced tumor necrosis factor receptor–related gene [GITR] agonist), alone and in combination with nivolumab in patients with advanced solid tumors
Author: Lillian L. Siu
Abstract #104
Clinical Science Symposium: "Check" This Out: The Step Beyond PD-1 Blockade
Sunday, June 4, 10:12–10:24 AM, Hall D1

Clinical Collaborations

Nivolumab + nab-paclitaxel + carboplatin in patients with non-small cell lung cancer: Interim results from a multicenter phase 1 study
Author: David Michael Waterhouse
Abstract #9095
Poster Session: Lung Cancer—Non-Small Cell Metastatic
Saturday, June 3, 8:00–11:30 AM, Hall A

Ceritinib plus nivolumab in patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer
Author: Enriqueta Felip
Abstract #2502
Oral Abstract Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Saturday, June 3, 1:39–1:51 PM, E450ab
Effect of a novel IL-2 cytokine immune agonist (NKTR-214) on proliferating CD8+T cells and PD-1 expression on immune cells in the tumor microenvironment in patients with prior checkpoint therapy
Author: Chantale Bernatchez
Abstract #2545
Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Monday, June 5, 8:00–11:30 AM, Hall A

A phase I study of enadenotucirev (EnAd), an oncolytic Ad11/Ad3 chimeric group B adenovirus, in combination with nivolumab in tumors of epithelial origin
Author: Wael A. Harb
Abstract #TPS3115
Poster Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 8:00–11:30 AM, Hall A

Epacadostat plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of ECHO-204
Author: Raymond P. Perez
Abstract #3003
Oral Abstract Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 2:15–2:27 PM, Hall D1

Clinical results with combination of anti-CD27 agonist antibody, varlilumab, with anti-PD1 antibody nivolumab in advanced cancer patients
Author: Rachel E. Sanborn
Abstract #3007
Oral Abstract Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 3:27–3:39 PM, Hall D1

International Immuno-Oncology Network (II-ON)

Function and expression of checkpoint inhibitors and immune agonists on immune cells in monoclonal gammopathy of undetermined significance, smoldering multiple myeloma and MM and tumor-specific T lymphocytes
Author: Jooeun Bae
Abstract #11577
Poster Session: Tumor Biology
Saturday, June 3, 1:15–4:45 PM, Hall A

Loss-of-function of PBRM1 to predict response to anti-PD-1/PD-L1 therapy in metastatic renal cell carcinoma
Author: Diana Miao
Abstract #3016
Poster Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 8:00–11:30 AM, Hall A
Discussed at the Poster Discussion Session on Monday, June 5, 2017, 4:45–6:00 PM, Hall D1

Metabolomic correlates of response in nivolumab-treated renal cell carcinoma and melanoma patients
Author: Marios Giannakis
Abstract #3036
Poster Session: Developmental Therapeutics—Immunotherapy
Monday, June 5, 8:00–11:30 AM, Hall A

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 35 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ individual tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About the International Immuno-Oncology Network (II-ON)

The II-ON, formed in 2012, is a global peer-to-peer collaboration between Bristol-Myers Squibb and academia advancing the science of Immuno-Oncology (I-O) through a series of preclinical, translational and biology-focused research objectives. The research in the collaboration is focused on three fundamental scientific pillars: understanding the mechanisms of resistance to immunotherapy; identifying patient populations likely to benefit from immunotherapy; and exploring novel combination therapies that may enhance anti-tumor response through complementary mechanisms of action. The II-ON facilitates the translation of scientific research findings into drug discovery and development, with the goal of introducing new treatment options into clinical practice.

In addition to Bristol-Myers Squibb, the II-ON currently comprises 15 leading cancer research institutions, including: Clinica Universidad Navarra, Columbia University Medical Center, Dana-Farber Cancer Institute, The Earle A. Chiles Research Institute (Providence Health & Services), Institut Gustave Roussy, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G. Pascale", Bloomberg-Kimmel Institute for Cancer Immunotherapy at the Johns Hopkins Kimmel Cancer Center, Memorial Sloan Kettering Cancer Center, National Cancer Center Japan, The Netherlands Cancer Institute, Peter MacCallum Cancer Centre, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, University College London, The University of Chicago and West German Cancer Center/University Hospital Essen.

On May 17, 2017 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that new and updated data from studies of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, June 2 – 6, 2017 (Press release, Merck & Co, MAY 17, 2017, View Source [SID1234519201]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Know more, wherever you are:
Latest on Cancer Drug Development at ASCO (Free ASCO Whitepaper), book your free 1stOncology demo here.

At this year’s meeting, researchers will present data from more than 50 abstracts investigating the use of KEYTRUDA as monotherapy and in novel combinations across 16 cancers, including non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancers, gastric cancer and breast cancer. Additional longer-term progression-free survival (PFS) and overall survival (OS) data for KEYTRUDA in monotherapy and as a combination therapy in first-line NSCLC from KEYNOTE-024 and KEYNOTE-021G will be presented. As noted in the abstracts, in KEYNOTE-024 significant improvement in OS was maintained with KEYTRUDA compared to chemotherapy with a longer follow-up of approximately six months; and in KEYNOTE-021G with more than five months of additional follow-up, a trend for improved OS with KEYTRUDA in combination with pemetrexed and carboplatin (pem/carbo) was observed when compared to pem/carbo alone, despite high rates of patient cross-over. Additional data on these findings will be presented at the meeting.

"Our data at ASCO (Free ASCO Whitepaper) bring to life the potential of KEYTRUDA across many different cancer types as both monotherapy and in combination, and underscore the remarkable progress that is being made in the fight against cancer," said Dr. Roy Baynes, senior vice president and head of global clinical development, Chief Medical Officer, Merck Research Laboratories. "In particular, we continue to show improved survival outcomes in the first-line treatment of both melanoma and non-small cell lung cancer, and we highlight clinical collaboration data that explore the potential of novel immunotherapy combinations as a treatment for patients with cancer."

In monotherapy, data for KEYTRUDA (pembrolizumab) will be presented in NSCLC, melanoma, urothelial carcinoma, gastric cancer and triple-negative breast cancer (TNBC), among others. In the combination setting, data for KEYTRUDA in NSCLC, TNBC and endometrial cancer, among others, will be presented. Additionally, studies providing insight into the role of biomarkers – such as PD-L1 and microsatellite-instability – across a variety of tumors and treatment settings will be presented. Merck continues to advance the study of genomic markers and signals that can help physicians to identify the treatment regimen that may be best for each patient.

Merck Data at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting

A select listing of the more than 50 Merck-sponsored and collaboration abstracts featuring KEYTRUDA is provided below. Data from studies of other oncology medicines in Merck’s portfolio and pipeline will also be presented at the meeting. For more information, including a complete list of abstract titles and presentation days and times, please visit the ASCO (Free ASCO Whitepaper) website at View Source

Advanced Bladder Cancers: Merck has the largest immuno-oncology development program in bladder cancer. In monotherapy, OS results from KEYNOTE-045, the phase 3 trial of KEYTRUDA compared to chemotherapy for patients with locally advanced or metastatic advanced urothelial carcinoma (a type of bladder cancer) in the second-line setting (Abstract #4501), will be presented. In addition, a biomarker analysis from KEYNOTE-052, the phase 2 trial of patients with advanced urothelial carcinoma in the first-line setting who are not eligible for cisplatin-based chemotherapy (Abstract #4502), will also be presented; data from both studies served as the basis for supplemental Biologics License Applications (sBLAs) for KEYTRUDA that are currently under review with the U.S. Food and Drug Administration (FDA). In the combination setting, new data will be presented from the phase 1/2 ECHO-202/KEYNOTE-037 study of KEYTRUDA (pembrolizumab) and Incyte’s investigational oral selective IDO1 enzyme inhibitor, epacadostat, in patients with advanced urothelial carcinoma (Abstract #4503).

Abstract #4501 Oral Session: Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC). D. Bajorin. Monday, June 5. 8:12 a.m. – 8:24 a.m. CDT. Location: Arie Crown Theater.
Abstract #4502 Oral Session: Biomarker findings and mature clinical results from KEYNOTE-052: First-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC). P. O’Donnell. Monday, June 5. 8:24 a.m. – 8:36 a.m. CDT. Location: Arie Crown Theater.
Abstract #4503 Oral Session: Epacadostat plus pembrolizumab in patients with advanced urothelial carcinoma: Preliminary phase I/II results of ECHO-202/KEYNOTE-037. D. Smith. Monday, June 5. 8:36 a.m. – 8:48 a.m. CDT. Location: Arie Crown Theater.
Advanced Breast Cancer and Other Women’s Cancers: Merck is currently conducting several studies investigating the potential for KEYTRUDA as a monotherapy and as a combination therapy in breast cancer, and in endometrial, ovarian and cervical cancers. Monotherapy data to be presented include two of the phase 2 KEYNOTE-086 study cohorts (A & B) of KEYTRUDA in patients with metastatic TNBC with varying levels of PD-L1 expression (Abstract #1008 and Abstract #1088, respectively). In the combination setting, findings will be presented investigating KEYTRUDA with chemotherapy in the neoadjuvant treatment setting for high-risk breast cancer (or TNBC) (Abstract #556 and Abstract #506, respectively), including results from the phase 2 I-SPY 2 TRIAL.

Abstract #1008 Oral Session: Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A. S. Adams. Saturday, June 3. 3:39 p.m. – 3:51 p.m. CDT. Location: Hall D1.
Abstract #1088 Poster Session: Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B. S. Adams. Sunday, June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Abstract #506 Oral Session: Pembrolizumab plus standard neoadjuvant therapy for high-risk breast cancer (BC): Results from I-SPY 2. R. Nanda. Monday, June 5. 11:45 a.m. – 11:57 a.m. CDT. Location: Hall D2.
Abstract #556 Poster Session: Pembrolizumab (pembro) + chemotherapy (chemo) as neoadjuvant treatment for triple negative breast cancer (TNBC): Preliminary results from KEYNOTE-173. P. Schmid. Sunday, June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Advanced Gastrointestinal (GI) Cancers: Data will be presented from the phase 2 registrational KEYNOTE-059 study of KEYTRUDA (pembrolizumab) in patients with advanced gastric cancer – the monotherapy cohort (Abstract #4003) and the combination cohort (Abstract #4012). Additionally, combination data from the clinical collaboration with Eli Lilly and Company investigating KEYTRUDA with ramucirumab will be presented (Abstract #4046).

Abstract #4003 Oral Session: KEYNOTE-059 cohort 1: Efficacy and safety of pembrolizumab (pembro) monotherapy in patients with previously treated advanced gastric cancer. C. Fuchs. Sunday, June 4. 9:00 a.m. – 9:12 a.m. CDT. Location: Hall D2.
Abstract #4012 Poster Session/Discussion: KEYNOTE-059 cohort 2: Safety and efficacy of pembrolizumab (pembro) plus 5-fluorouracil (5-FU) and cisplatin for first-line (1L) treatment of advanced gastric cancer. YJ. Bang. Saturday, June 3. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 4:45 p.m. – 6:00 p.m. CDT. Location: Hall D2.
Abstract #4046 Poster Session: Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study. I. Chau. Saturday, June 3. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Advanced Head and Neck Cancer: In advanced head and neck squamous cell carcinoma (HNSCC), a study evaluating the role of genomic determinants of response to KEYTRUDA monotherapy (Abstract #6009) will be presented. In the combination setting, researchers will present data from the ECHO-202/KEYNOTE-037 trial, which is studying KEYTRUDA in combination with Incyte’s epacadostat (Abstract #6010).

Abstract #6009 Clinical Science Symposium: Genomic determinants of response to pembrolizumab in head and neck squamous cell carcinoma (HNSCC). R. Haddad. Tuesday, June 6. 8:00 a.m. – 8:12 a.m. CDT. Location: S100a.
Abstract #6010 Clinical Science Symposium: Epacadostat plus pembrolizumab in patients with SCCHN: Preliminary phase I/II results from ECHO-202/KEYNOTE-037. O. Hamid. Tuesday, June 6. 8:12 a.m. – 8:24 a.m. CDT. Location: S100a.
Advanced Lung Cancer: Merck is continuing to advance understanding of the important role of KEYTRUDA (pembrolizumab) in metastatic lung cancer both as monotherapy and in combination with other therapies. In monotherapy, PFS and updated OS data from the phase 3 KEYNOTE-024 trial of patients with advanced NSCLC whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] (Abstract #9000) will be presented. In the combination setting, additional follow-up will be presented from the phase 1/2 KEYNOTE-021G study (Abstract #9094), including OS. KEYNOTE-021G was the basis of the recent approval of KEYTRUDA in combination with pemetrexed and carboplatin for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. In addition, data will be presented from ECHO-202/KEYNOTE-037 investigating KEYTRUDA with epacadostat in patients with NSCLC (Abstract #9014).

Abstract #9000 Oral Session: Progression after the next line of therapy (PFS2) and updated OS among patients (pts) with advanced NSCLC and PD-L1 tumor proportion score (TPS) ≥50% enrolled in KEYNOTE-024. J. Brahmer. Tuesday, June 6. 9:45 a.m. – 9:57 a.m. CDT. Location: Hall D1.
Abstract #9094 Poster Session: First-line carboplatin and pemetrexed (CP) with or without pembrolizumab (pembro) for advanced nonsquamous NSCLC: Updated results of KEYNOTE-021 cohort G. V. Papadimitrakopoulou. Saturday, June 3. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Abstract #9014 Poster Session/Discussion: Efficacy and safety of epacadostat plus pembrolizumab treatment of NSCLC: Preliminary phase I/II results of ECHO-202/KEYNOTE-037. T. Gangadhar. Saturday, June 3. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 3:00 p.m. – 4:15 p.m. CDT. Location: Hall D2.
Advanced Melanoma: In monotherapy, longer-term OS data from the phase 3 KEYNOTE-006 trial (Abstract #9504) of KEYTRUDA will be presented. In combination studies, early findings from the phase 1b/2 KEYNOTE-184 study of Dynavax’s intratumoral SD-101 in combination with KEYTRUDA in anti-PD-1 naïve and experienced metastatic melanoma patients (Abstract #9550) will be presented, as will updated data from the KEYNOTE-029 study of KEYTRUDA with ipilimumab (Abstract #9545). In addition, data from the phase 2 KEYNOTE-142 study of Syndax’s entinostat in combination with KEYTRUDA (pembrolizumab) in patients with advanced melanoma (Abstract #9529) will be presented for the first time.

Abstract #9504 Oral Session: Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment. C. Robert. Sunday, June 4. 9:12 a.m. – 9:24 a.m. CDT. Location: Arie Crown Theater.
Abstract #9550 Poster Session: Phase 1b/2, open label, multicenter, study of intratumoral SD-101 in combination with pembrolizumab in anti-PD1 naïve & experienced metastatic melanoma patients. A. Leung. Saturday, June 3. 1:15 p.m. – 4:45 p.m. CDT. Location: Hall A.
Abstract #9545 Poster Session: KEYNOTE-029: Efficacy and safety of pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma. M. Carlino. Saturday, June 3. 1:15 p.m. – 4:45 p.m. CDT. Location: Hall A.
Abstract #9529 Poster Session: Melanoma/Skin Cancers, ENCORE 601: A phase II study of entinostat (ENT) in combination with pembrolizumab (PEMBRO) in patients with melanoma. M. Johnson. Saturday, June 3. 1:15 p.m. – 4:45 p.m. CDT. Location: Hall A.
Advanced Microsatellite-Instability (MSI) High Cancers: Merck is advancing the use of biomarkers to guide clinical decision making, including for patients with MSI-High advanced malignancies. At ASCO (Free ASCO Whitepaper), monotherapy data from KEYNOTE-164 and KEYNOTE-158 will be presented in patients with high levels of MSI (Abstract #3071).

Abstract #3071 Poster Session: Pembrolizumab therapy for microsatellite instability high (MSI-H) colorectal cancer (CRC) and non-CRC. L. Diaz. Monday, June 5. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Advanced Renal Cell Carcinoma (RCC): New data from studies of KEYTRUDA in combination in patients with advanced RCC will also be presented, including preliminary data for KEYTRUDA combined with epacadostat from the ECHO-202/KEYNOTE-037 trial (Abstract #4515) and for KEYTRUDA combined with Novartis’ pazopanib (Abstract #4506).

Abstract #4515 Poster Session/Discussion: Epacadostat plus pembrolizumab in patients with advanced RCC: Preliminary phase I/II results from ECHO-202/KEYNOTE-037. P. Lara. Sunday, June 4. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 11:30 a.m. – 12:45 a.m. CDT. Location: Arie Crown Theater.
Abstract #4506 Oral Session: A phase I/II study to assess the safety and efficacy of pazopanib (PAZ) and pembrolizumab (PEM) in patients (pts) with advanced renal cell carcinoma (aRCC). S. Chowdhury. Monday, June 5. 9:36 a.m. – 9:48 a.m. CDT. Location: Arie Crown Theater.
Merck Investor Event: Merck will hold an investor event in conjunction with the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 5 at 5:45 p.m. CDT (6:45 p.m. EDT). Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source or by dialing (866) 486-2604 – and using ID code number 3314336.

About KEYTRUDA (pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including the exploration of several different biomarkers across a broad range of tumors.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA (pembrolizumab), as a single agent, is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In adults with cHL, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%) pneumonitis, and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism, hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%) hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA (pembrolizumab) for Grade 3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse reactions. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Solid organ transplant rejection has been reported in postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider benefit of treatment with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA (pembrolizumab) can cause severe or life-threatening infusion-related reactions, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and symptoms of infusion-related reactions, including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after being treated with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with KEYTRUDA on any trial, 6 patients (26%) developed graft-versus-host-disease (GVHD), one of which was fatal, and 2 patients (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, one of which was fatal. Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC. The most common adverse event resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.8%). Adverse reactions leading to interruption of KEYTRUDA occurred in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation (1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most common adverse reactions (occurring in at least 20% of patients and at a higher incidence than with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).

When KEYTRUDA was administered in combination with pemetrexed and carboplatin, KEYTRUDA was discontinued in 10% of 59 patients. The most common adverse reaction resulting in discontinuation of KEYTRUDA (≥2%) was acute kidney injury (3.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 39% of patients; the most common (≥2%) were fatigue (8%), neutrophil count decreased (8%), anemia (5%), dyspnea (3.4%), and pneumonitis (3.4%).The most common adverse reactions (≥20%) with KEYTRUDA (pembrolizumab) compared to carbo/pem alone were fatigue (71% vs 50%), nausea (68% vs 56%), constipation (51% vs 37%), rash (42% vs 21%), vomiting (39% vs 27%), dyspnea (39% vs 21%), diarrhea (37% vs 23%), decreased appetite (31% vs. 23%), headache (31% vs 16%), cough (24% vs 18%), dizziness (24%vs 16%), insomnia (24% vs 15%), pruritus (24% vs 4.8%), peripheral edema (22% vs 18%), dysgeusia (20% vs 11%), alopecia (20% vs 3.2%), upper respiratory tract infection (20% vs 3.2%), and arthralgia (15% vs 24%). The study was not designed to demonstrate a statistically significant difference in adverse reaction rates for KEYTRUDA plus chemotherapy, as compared to chemotherapy alone, for any specified adverse reaction.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

On May 17, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that abstracts from two clinical studies of its IDO pathway inhibitors, indoximod and navoximod (GDC-0919), used in combination with other agents, are now available on the website of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NewLink Genetics, MAY 17, 2017, View Source [SID1234519192]).

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An infographic accompanying this announcement is available at View Source

"The IDO pathway is a key immuno-oncology target and NewLink Genetics has two separate and distinct IDO pathway inhibitors in clinical development. Indoximod, which is wholly owned by NewLink Genetics, has a proposed differentiated mechanism within the IDO pathway and acts as a tryptophan mimetic having a direct effect on immune cells to reverse immune suppression used by cancer to protect itself. Navoximod is our direct enzymatic inhibitor of IDO and is partnered with Genentech/Roche," said Charles J. Link, Jr., M.D., Chief Executive Officer and Chief Scientific Officer of NewLink Genetics.

Indoximod in combination with the therapeutic cancer vaccine, PROVENGE

Results from a randomized, double-blind, placebo-controlled, multi-institutional Phase 2 investigator initiated study with indoximod in combination with the therapeutic cancer vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer will be presented as a poster (Abstract number 3066) by Gautam Gopalji Jha, M.D., Adjunct Assistant Professor, Division of Hematology and Oncology, University of Minnesota, at ASCO (Free ASCO Whitepaper) in Chicago on Monday, June 5, 2017, 8:00 a.m. – 11:30 a.m. CT, titled, A phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

In the study, forty-six patients were randomized into two arms to receive either twice daily oral indoximod (n=22) or placebo (n=24) for 6 months beginning the day after the third and final PROVENGE infusion. Conclusions indicate that treatment with the IDO pathway inhibitor, indoximod, post PROVENGE therapy, leads to significant improvement in radiographic progression free survival (rPFS) when compared to placebo and is well-tolerated.

Key findings presented from the study include:

Statistically significant improvement in median rPFS was 10.3 months in the treatment arm compared to 4.1 months in the placebo arm (p = 0.011)
Median Overall Survival (OS) has not yet been reached
Patients tolerated therapy with indoximod with no significant differences in adverse events between the two arms
There was no statistical difference in the primary endpoint of ELISPOT assay immune response to PA2024, the PROVENGE-related fusion protein, in the 35 of 46 patients who had clinical samples available for testing
"These data further support the hypothesis that targeting the IDO Pathway in combination with a broad backbone of treatment regimens including chemotherapy, anti-PD-1 antibodies and therapeutic vaccines across multiple indications has the potential to provide meaningful clinical benefit without compromising tolerability," commented Nicholas N. Vahanian, M.D., President and Chief Medical Officer of NewLink Genetics.

Navoximod in combination with TECENTRIQ (atezolizumab) in multiple solid tumors

Initial data from a Phase 1b dose-escalation study of navoximod in combination with TECENTRIQ for patients with locally advanced or metastatic solid tumors conducted by our partner, Genentech/Roche, will be presented in an oral presentation (Abstract number 105) by Howard A. "Skip" Burris, III, M.D., President Clinical Operations and Chief Medical Officer, Sarah Cannon Research Institute, at ASCO (Free ASCO Whitepaper) in Chicago on Sunday, June 4, 2017, 10:24 a.m. CT. The presentation is titled, A phase 1b dose-escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients with locally advanced or metastatic solid tumors.

This Phase 1b, open-label, dose-escalation study is designed to characterize safety and tolerability. Secondary objectives include identifying a maximum tolerated dose (MTD) and recommended Phase 2 dose, and evaluating pharmacokinetics, pharmacodynamics, and anti-tumor activity. Patients were given TECENTRIQ (1200 mg IV every 3 weeks) and escalating doses of navoximod (orally twice daily, for 21 days) using a standard 3+3 design. Initial results from this study (n=52, non-selected heterogeneous population during the dose escalation) found the combination was generally well-tolerated, with peripheral IDO1 modulation, and some early activity signals. Patients were previously treated with prior systemic therapies with a median number of 3 and a range of 1-9. Two patients also received prior immunotherapy.

The design of the trial includes the initial dose-escalation phase reported in this abstract, followed by disease-specific expansion cohorts (enrollment target is 305 patients) for patients with select tumor types including non-small-cell lung cancer (NSCLC), renal cell cancer (RCC), urothelial bladder cancer (UBC), triple negative breast cancer (TNBC), to further evaluate safety, response, and peripheral and tumor pharmacodynamics. Updates for this study will continue to be reported by Genentech/Roche.

Dr. Vahanian continued, "We are encouraged by the clinical profile for the combination of navoximod and atezolizumab from the first phase of this combination trial and look forward to the data for the disease-specific expansion cohorts which are currently accruing patients."

On May 17, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML (Press release, GlycoMimetics, MAY 17, 2017, View Source [SID1234617412]). The U.S. Food and Drug Administration (FDA) had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 in AML.

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In the ongoing clinical trial, GMI-1271 is being administered, along with chemotherapy, to patients with relapsed or refractory AML as well as those 60 years of age and older with newly diagnosed disease. Data from this trial were presented in 2016 at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper). In the trial, patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients. In March 2017, the Company announced that the first of two patient cohorts in the Phase 2 portion of the trial of GMI-1271 had completed enrollment. In April 2017, the Company announced plans to present further data updates on both patient populations in the ongoing AML trial at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.

The FDA grants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDA standards for new drug approval.

"The FDA’s granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population," said Helen Thackray, MD, Chief Medical Officer of GlycoMimetics. "We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible."

About AML

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.

On May 17, 2017 Redx (AIM: REDX) reported its interim results for the six months ended 31 March 2017 (Press release, Redx Pharma, MAY 17, 2017, View Source [SID1234524750]):

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Clinical trial application filed for Porcupine inhibitor RXC004
Development candidate chosen for reversible BTK inhibitor RXC005 for drug resistant chronic lymphocytic leukaemia
Strategic restructuring completed post period; estimated £4.2 million annual cost saving
Iain Ross appointed as Non-Executive Chairman of the Board from 1 May 2017
£12 million gross raised in March 2017, including a subscription with a related sharing agreement
Pipeline highlights
RXC004 — our "best-in-class" Porcupine inhibitor
Clinical trial application (CTA) filed post period in April
Scheduled to enter first-in-human studies upon CTA approval
Shown to have the potential to be used in combination with immune checkpoint inhibitors (anti-PD-1)
RXC005 — our "best-in-class" reversible BTK inhibitor
In vivo proof of concept achieved for the reversible BTK program
Development candidate nominated for drug resistant chronic lymphocytic leukaemia (CLL)
Pre-clinical profile presented at ASH (Free ASH Whitepaper) meeting in December 2016 and iwCLL in May 2017
Investigational new drug (IND) application and CTA to be filed around the end of 2017
Other highlights
Fibrotic disease selected as core immunology research area
Redx acquired the locally acting Rho kinase (ROCK) inhibitor AMA0825 from Amakem NV in March 2017 for an undisclosed amount. ROCK is a promising anti-fibrotic target and AMA0825 is at late lead optimisation stage
Redx was awarded US$1 million competitive grant by CARB-X to enable the Company to advance its Gram-negative anti-infective program with a prospective partner
Key Financials
Net cash at 31 March 2017: £5.1m (2016: £4.4m)
Comprehensive loss: £10.7m (2016: £7.1m)
Strategic refocus expected to deliver annual cost savings of £4.2 million
Dr Neil Murray, Chief Executive Officer of Redx Pharma, commented, "Redx Pharma is now optimally positioned to capitalise on the potential of its world class discovery engine with the transition to clinical development of our two best-in-class assets RXC004 and RXC005 in oncology. I am also excited by the potential of our pipeline in fibrosis, bringing novel medicines to areas of severe unmet need. We look forward to announcing the start of our first clinical trial with RXC004 and to building greater value for our shareholders as a clinical stage business."

Iain Ross, Chairman of Redx Pharma, added,"I have been impressed by the potential of Redx Pharma’s science, approach to drug discovery and the speed with which the Company has created a world class pipeline of best-in-class products. Following the recent re-structuring of the organisation we are now focused on implementing an aggressive strategy to accelerate the "realisation of value" by progressing the clinical and commercial development of our lead programs and maximising the long term potential of the pipeline. I am delighted to be working with the Redx team."