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Astellas Announces Oncology Portfolio Updates

On May 17, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported an update regarding the Company’s diverse oncology portfolio, including the acceptance of a wide selection of abstracts across a broad range of cancers for oral or poster presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6 in Chicago (Press release, Astellas, MAY 17, 2017, View Source [SID1234519195]).

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Astellas is presenting a record number of abstracts at ASCO (Free ASCO Whitepaper), including data for gilteritinib in acute myeloid leukemia, enfortumab vedotin in urothelial cancer, and IMAB362 from the recently acquired Ganymed. A number of XTANDI (enzalutamide) abstracts accepted for presentation also speak to the comprehensive clinical trial program in metastatic CRPC and other prostate cancer populations. In just over a decade, Astellas has built a leadership position and substantial Oncology pipeline through a thoughtful blend of investments in organic R&D, strategic business development and strong collaborative partnerships with some of the most renowned institutions around the world.

"We are thrilled to announce our largest presence to date at this year’s ASCO (Free ASCO Whitepaper) meeting," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We believe these data reflect significant progress in our pursuit to create innovative treatment options for some of the most difficult-to-treat cancers and further underscore our ongoing commitment to becoming a world-class oncology company focusing on patients with cancer."

Additionally, the Company announced today the joint decision with Pfizer to discontinue the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. The companies have also decided that based on the enzalutamide data from the Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time.

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide is not approved for use in patients with breast cancer.

Agios to Present New Clinical Data from its IDH Programs at ASCO

On May 17, 2017 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic diseases, reported that new data from its isocitrate dehydrogenase (IDH) programs will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2017 in Chicago (Press release, Agios Pharmaceuticals, MAY 17, 2017, View Source [SID1234519194]).

In total, three abstracts led by Agios describing new data from the company’s IDH programs have been accepted for presentation at ASCO (Free ASCO Whitepaper), as well as two abstracts led by Celgene. IDHIFA (enasidenib) is being developed in collaboration with Celgene.

The accepted abstracts are listed below and are available online on the ASCO (Free ASCO Whitepaper) conference website: View Source

Oral presentation by Agios and Celgene:

Title: Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): Results of a phase 1 dose-escalation and expansion study
Date & Time: Tuesday, June 6, 2017 from 10:57-11:09 a.m. CT
Oral Abstract Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7004
Location: E450ab
Presenter: Eytan Stein, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College
This abstract has been selected as part of the "Best of ASCO (Free ASCO Whitepaper)" program to be presented in cities across the country. "Best of ASCO (Free ASCO Whitepaper)" features the top abstracts, highlighting the most cutting-edge science and education from the annual meeting.

Poster discussions and poster presentations by Agios and/or Celgene:

Title: Phase 1 study of AG-120, an IDH1 mutant enzyme inhibitor: results from the cholangiocarcinoma dose escalation and expansion cohorts
Poster Session Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Discussion Date & Time: Saturday, June 3, 2017 from 5:21-5:33 p.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4015
Poster Board: 7
Poster Location: Hall A
Poster Discussion Location: Hall D2
Presenter: Maeve Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College

Title: Differentiation syndrome associated with enasidenib, a selective inhibitor of mutant isocitrate dehydrogenase 2 (mIDH2)
Poster Session Date & Time: Monday, June 5, 2017 from 8:00-11:30 a.m. CT
Poster Discussion Date & Time: Monday, June 5, 2017 from 12:06-12:18 p.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7015
Poster Board: 215
Poster Location: Hall A
Poster Discussion Location: E354b
Presenter: Amir Tahmasb Fathi, M.D., Massachusetts General Hospital and Harvard Medical School

Title: Pharmacokinetic/pharmacodynamic (PK/PD) profile of AG-120 in patients with IDH1-mutant cholangiocarcinoma from a phase 1 study of advanced solid tumors
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4082
Poster Board: 74
Location: Hall A
Author: Bin Fan, Ph.D., Agios Pharmaceuticals

Title: ClarIDHy: A phase 3, multicenter, randomized, double-blind study of AG-120 vs placebo in patients with an advanced cholangiocarcinoma with an IDH1 mutation
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: TPS4142
Poster Board: 128b
Location: Hall A
Author: Maeve Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College

Puma Biotechnology Announces Publication of Neratinib Abstract for the 2017 ASCO Annual Meeting

On May 17, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of an abstract on its drug candidate PB272 (neratinib) that will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 2–6, 2017, in Chicago (Press release, Puma Biotechnology, MAY 17, 2017, View Source [SID1234519193]). Abstracts are available to the public online on the ASCO (Free ASCO Whitepaper) website: www.abstract.asco.org.

Abstract #1005, TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM).

The abstract will be presented as an Oral Abstract Session: Breast Cancer–Metastatic; Saturday, June 3, 1:15–4:15 p.m. CDT, Hall D1.

Data from Clinical Studies of NewLink Genetics’ Two Distinct IDO Pathway Inhibitors to Be Presented at ASCO 2017

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]).

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."

Juno Therapeutics to Present Key Clinical Data Updates on JCAR017 and JCAR014 at the 2017 American Society of Clinical Oncology Annual Meeting

On May 17, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that it will present key clinical updates in partnership with its collaborators on its investigational products JCAR017 and JCAR014 at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2017 in Chicago, Illinois, June 2-6 (Press release, Juno, MAY 17, 2017, View Source [SID1234519190]).

JCAR017 and JCAR014 are chimeric antigen receptor (CAR) T cell product candidates that target CD19, a protein expressed on the surface of almost all B cell malignancies, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL). While the manufacturing process and final cell product differ, both product candidates utilize the 4-1BB co-stimulatory domain and use a defined cell manufacturing process, controlling the type of cells a patients receives with the goal of delivering an improved therapeutic benefit.
Insights from studies of the translational product JCAR014 are being applied to the development of JCAR017.

New data from the ongoing Phase I TRANSCEND NHL 001 trial (NCT02631044) evaluating JCAR017 in adult patients with relapsed or refractory aggressive NHL [diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL)] will be presented, with increased patient numbers and longer duration of follow-up reported at two dose levels as compared to previous presentations. Updated safety data will also be presented from the ongoing Phase I trial (NCT01865617) evaluating JCAR014 in adult patients with relapsed or refractory ALL, NHL, or CLL. The JCAR014 presentation will also include data on clinical and laboratory biomarkers that may allow early identification of cytokine release syndrome (CRS) and neurotoxicity (NT).

Key data presentations at ASCO (Free ASCO Whitepaper) include:

JCAR017
CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with the CD19-Directed CAR T Cell Product JCAR017 (TRANSCEND NHL 001) (Abstract #7513)
Presenter: Jeremy Abramson, M.D., Massachusetts General Hospital
Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #275
Poster Discussion & Location: Monday, June 5, 2017: 1:15 – 2:30 p.m. Central Time; Room E354b

JCAR014
Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) after CD19-Specific Chimeric Antigen Receptor-Modified T cells (Abstract #3020)
Presenter: Kevin Hay, M.D., MSc, Fred Hutchinson Cancer Research Center
Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #115
Poster Discussion & Location: Monday, June 5, 2017: 4:45 – 6:00 p.m. Central Time; Hall D1

About Juno’s Chimeric Antigen Receptor and T Cell Receptor Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established. They are not approved by any regulatory authority.