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 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported promising safety and efficacy data from monotherapy and combination studies with mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive epithelial ovarian cancer (EOC) (Press release, ImmunoGen, MAY 17, 2017, View Source [SID1234519186]).

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These data include results from pooled analyses of three Phase 1 expansion cohorts and from a Phase 1b/2 study, FORWARD II, evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, Doxil (pegylated liposomal doxorubicin), or Keytruda (pembrolizumab). These results will be presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 2-7, 2017 in Chicago, IL.

Anti-Tumor Activity and Safety Analyses in Pooled Phase 1 Expansion Cohorts

Data from the pooled analyses demonstrate the safety and efficacy profile of mirvetuximab soravtansine in the patient population eligible for the ongoing Phase 3 registration trial, FORWARD I. These data include 113 EOC patients treated with mirvetuximab soravtansine in three expansion cohorts in the Phase 1 trial. In the subset of 36 patients meeting the key eligibility criteria for FORWARD I, which includes patients with platinum-resistant disease and medium or high levels of FRα and who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 47 percent (95% CI 30, 65) and median progression-free survival (mPFS) was 6.7 months (95% CI 4.1, 8.3).

"The data observed with mirvetuximab compare favorably with outcomes typically achieved with currently available single-agent therapies for platinum resistant ovarian cancer. Current single-agent therapies for platinum-resistant ovarian cancer have low response rates of 15 to 20% and short median progression-free survival of three to four months," stated Kathleen Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma. "Based on the consistent safety and efficacy seen with mirvetuximab soravtansine reflected in these pooled analyses, particularly in those patients meeting the eligibility criteria for the pivotal study, I am very encouraged about the potential of this compound in patients with platinum-resistant ovarian cancer and look forward to continued progress with the ongoing Phase 3 FORWARD I trial."

For all 113 patients, the median number of prior regimens was 3, 85 percent had platinum-resistant disease, 67 percent had prior bevacizumab, and 22 percent had a prior poly (ADP-ribose) polymerase (PARP) inhibitor. The safety profile of the pooled population was consistent with data previously reported (2016 ASCO (Free ASCO Whitepaper) Annual Meeting), which consisted primarily of low grade, manageable adverse events. In this heavily pretreated group of patients, the confirmed ORR was 30 percent (95% CI 22, 39) and mPFS was 4.3 months (95% CI 3.9, 5.4).

Initial Safety and Preliminary Efficacy Data from FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in patients with FRα-positive EOC, primary peritoneal, or fallopian tube tumors. The data from these arms demonstrate mirvetuximab soravtansine may complement currently available therapies for FRα-positive EOC in a range of treatment settings, including earlier lines of therapy.

The safety profiles for these combinations were manageable and as expected, based on known profiles of each agent, with no new safety signals identified. Key findings in over 60 patients from the dose escalation phase of FORWARD II are as follows:

Patients in the Avastin arm were heavily pretreated with a median of six prior regimens. The confirmed ORR for this arm was 29 percent (95% CI 8, 58), with a median PFS of 9.5 months (95% CI 3.5, 15.2).
Patients with recurrent platinum-sensitive disease on the carboplatin arm had received a median of three prior regimens and the confirmed ORR was 65 percent (95% CI 38, 86), with a median PFS of 12.1 months (95% CI 9.0, 15.0).
Patients on the Doxil arm received a median of two prior regimens. The confirmed ORR for the Doxil arm was 13 percent (95% CI 2, 38), with a median PFS of 7.0 months (95% CI 1.7, upper bound not estimated).
Preliminary data from the Keytruda arm demonstrate that, similar to the other combinations, full doses of each agent are combinable. At this time, it is too early to assess anti-tumor activity data in this arm; anti-tumor activity will be reported at a subsequent medical meeting.

Based on the encouraging profiles of these combinations in dose escalation, ImmunoGen is moving forward with expansion cohorts for Avastin and Keytruda and is evaluating future studies with carboplatin combinations.

"The favorable safety profile of mirvetuximab soravtansine lends itself well to combination, as evidenced by the data from FORWARD II, showing the full dose of mirvetuximab soravtansine combines with the full doses of bevacizumab (Avastin), carboplatin, pembrolizumab (Keytruda) and pegylated liposomal doxorubicin (Doxil) in ovarian cancer," stated David O’Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center.

FORWARD I Trial

The Phase 3 FORWARD I trial was designed based on the promising monotherapy mirvetuximab soravtansine data from the Phase 1 trial and reflects the fastest registration strategy to obtain full approval of mirvetuximab soravtansine as single-agent therapy.

FORWARD I is a registration trial in which 333 patients will be randomized 2:1 and will receive either mirvetuximab soravtansine or the physicians’ choice of therapy (Doxil, paclitaxel, or topotecan). The study is currently enrolling in North America and Europe, with more than 100 sites expected to be activated in these geographies.

"The Phase 1 expansion cohort data being presented at ASCO (Free ASCO Whitepaper) support the potential of mirvetuximab soravtansine in the patient population eligible for FORWARD I," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "With the safety and efficacy profile demonstrated by these data, we look forward to completing enrollment in FORWARD I and evaluating mirvetuximab soravtansine with other therapies, including novel agents, in earlier lines of treatment."

ASCO Presentation Details:

Saturday, June 3, 2017

Title: Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm – 4:45pm CDT
Location: Poster Board No.: 369, Location: Hall A
Abstract: 5547

Title: Safety findings from FORWARD II: A phase 1b study evaluating the folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or pembrolizumab in patients (pts) with ovarian cancer.
Presenter: David O’Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center
Time: 1:15pm – 4:45pm CDT
Location: Poster Board No.: 375, Location: Hall A
Abstract: 5553

Title: FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm – 4:45pm CDT
Location: Poster Board No.: 425b, Location: Hall A
Abstract: TPS5607

Additional information – including presentation schedule and full abstracts – can be found www.asco.org.

Conference Call Information

ImmunoGen will host a conference call on Friday, May 19 at 8:00am ET. At this briefing, ImmunoGen will discuss the data being presented at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting. To access the live call by phone, dial 719-325-2402; the conference ID is 4522749. The call may also be accessed through the "Investors" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 1, 2017.

About ImmunoGen, Inc.

ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen’s lead candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche’s marketed product, Kadcyla, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.

Avastin, Doxil, Keytruda and Kadcyla are registered trademarks of their respective owners.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including mirvetuximab soravtansine, including risks related to preclinical and clinical studies, their timings and results. A review of these risks can be found in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other reports filed with the Securities and Exchange Commission.

On May 17, 2017 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported that updated interim data from its study of bb2121, the company’s anti-BCMA CAR T cell therapy will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, bluebird bio, MAY 17, 2017, View Source;p=RssLanding&cat=news&id=2273747 [SID1234519182]). bb2121 is currently being studied in a Phase 1 trial in patients with relapsed/refractory multiple myeloma.

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!

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"This past November we presented the initial clinical data from the first three dosing cohorts in this ongoing Phase 1 study of bb2121 in patients with relapsed/refractory multiple myeloma. At ASCO (Free ASCO Whitepaper) in June, we look forward to presenting data on those same patients with longer follow-up, as well as safety and efficacy data on an additional 9 patients treated subsequently." said David Davidson, M.D., chief medical officer, bluebird bio. "These data will advance our understanding of the bb2121 risk-benefit profile and inform planning with our partners at Celgene for the dose expansion cohort of this study, and the design of a potential pivotal study."

First-in-Human Multicenter Study of bb2121 anti-BCMA CAR T Cell Therapy for Relapsed/Refractory Multiple Myeloma: Updated Results (Abstract #3010).

Presenter: Jesus G. Berdeja, M.D., Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN
Date: Monday, June 5, 2017, 4:45-6:00 pm CT (poster discussion); 8:00-11:30 am CT
Location: Hall D1
Session Title: Poster Discussion Session: Developmental Therapeutics—Immunotherapy

The event and live webcast will begin at 6:30 p.m. CT (7:30 p.m. ET) on Monday, June 5. To access the live webcast, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

On May 17, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported it will present data about the company’s portfolio of approved and investigational oncology medicines during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2-6, in Chicago. A total of 23 abstracts have been accepted across several tumor types including brain cancer, hematologic malignancies, breast cancer, lung cancer and other solid tumors (Press release, AbbVie, MAY 17, 2017, View Source [SID1234519180]).

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Researchers will present efficacy and safety data on depatuxizumab mafodotin (previously known as ABT-414), an antibody-drug conjugate (ADC) being studied for the treatment of adults with amplified-epidermal growth factor receptor (EGFR) newly diagnosed or recurrent glioblastoma (GBM). GBM is one of the most aggressive cancers, with a five-year survival rate of approximately 6 percent in the U.S. and 24 European countries.1,2 The most common genetic alteration in GBM, EGFR-amplification, occurs in approximately 50 percent of GBM patients.3,4

Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein; and other early-stage investigational compounds.

AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments.

"AbbVie’s data presentations at this year’s ASCO (Free ASCO Whitepaper) meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment."

AbbVie abstracts:

Ibrutinib

Long-Term Efficacy and Safety with Ibrutinib (ibr) in Previously Treated Chronic Lymphocytic Leukemia (CLL): Up to Four Years Follow-Up of the RESONATE Study; Byrd et al.; Abstract 7510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 1:15 p.m.-2:30 p.m. CDT
Ibrutinib vs Chlorambucil: Immunophenotypic and Quantitative Impacts on Circulating Immune Cells in Chronic Lymphocytic Leukemia (CLL); Solman et al.; Abstract 7524; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Randomized, Double-Blind Phase III Study of Ibrutinib versus Placebo in Combination with Corticosteroids in Patients with New Onset Chronic Graft Versus Host Disease; Miklos et al.; Abstract TPS7072; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab Versus Placebo in Combination with Rituximab in Patients with Treatment-Naïve Follicular Lymphoma (PERSPECTIVE); Fowler et al.; Abstract TPS7576; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.- 11:30 a.m. CDT

Venetoclax

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax Combined with Azacitidine Versus Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia; Potluri et al.; Abstract TPS7069; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Phase 2, Open-Label Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; Bueno et al.; Abstract TPS8056; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Venetoclax (VEN) in Patients with Relapsed Non-Hodgkin Lymphoma (NHL); Davids et al.; Publication

Depatuxizumab mafodotin (ABT-414)

Efficacy Analysis of ABT-414 with or without Temozolomide (TMZ) in Patients (pts) with EGFR-Amplified, Recurrent Glioblastoma (rGBM) from a Multicenter, International Phase I Clinical Trial; van den Bent et al.; Abstract 2003; Oral Presentation; Sunday, June 4, 2017; 9:00 a.m.-9:12 a.m. CDT

Rovalpituzumab tesirine (Rova-T)

A Phase III Study of Rovalpituzumab Tesirine Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients with Extensive Disease Small Cell Lung Cancer (ED SCLC); Komarnitsky et al.; Abstract TPS8583; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Molecular Profiling of Small Cell Bladder Cancer (SCBC) to Reveal Gene Expression Determinants of Aggressive Phenotype; Koshkin et al.; Abstract 4529; Poster Presentation; Sunday, June 4, 2017; 8:00 a.m.-11:30 a.m. CDT
A Study of Rovalpituzumab Tesirine in Frontline Treatment of Patients with DLL3 Expressing Extensive Small Cell Lung Cancer; Hann et al.; Abstract TPS2598; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
An Open-Label Study of Rovalpituzumab Tesirine in Patients with DLL3-Expressing Advanced Solid Tumors; Kavalerchik et al.; Abstract TPS2597; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Rovalpituzumab Tesirine (Rova-T) as a Therapeutic Agent for Neuroendocrine Prostate Cancer (NEPC); Puca et al.; Abstract 5029; Poster Presentation; Monday, June 5, 2017; 1:15 p.m.-4:45 p.m. CDT

Veliparib

Phase 1/2 Study of Veliparib (V) Combined with Carboplatin (Cb) and Etoposide (E) in Patients (Pts) with Extensive-Stage Disease (ED) Small Cell Lung Cancer (SCLC) and Other Solid Tumors: Phase 1 Results; Atrafi et al.; Abstract 8530; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Tolerability of Veliparib (V) in Combination with Carboplatin (C)/Paclitaxel (P): Based Chemoradiotherapy (CRT) in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC); Kozono et al.; Abstract 8546; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Breast Conservation after Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results from an International Randomized Trial (BrighTNess); Golshan et al.; Abstract 514; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Phase 3 Study Evaluating Efficacy and Safety of Veliparib (V) Plus Carboplatin (Cb) or Cb in Combination with Standard Neoadjuvant Chemotherapy (NAC) in Patients (Pts) with Early Stage Triple-Negative Breast Cancer (TNBC); Geyer et al.; Abstract 520; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

Elotuzumab

Phase 3 ELOQUENT-2 Study: Extended Four Year Follow-Up (FU) of Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.; Abstract 8028; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
CheckMate 602: An Open-Label, Randomized, Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma; Lonial et al.; Abstract TPS8052; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

ABBV-221

Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR; Calvo et al.; Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

ABBV-399

Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC); Angevin et al.; Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC); Awad et al.; Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT

ABT-348

Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib; Maitland et al.; Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

The ASCO (Free ASCO Whitepaper) 2017 Annual Meeting abstracts are available at View Source

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."