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]). Schedule your 30 min Free 1stOncology Demo! 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.
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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
Month: May 2017
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. Schedule your 30 min Free 1stOncology Demo! 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).
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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]).
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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
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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."
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]).
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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
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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.
Kite Announces Presentations on Its Lead CAR-T Therapy Development Program at the 2017 American Society of Clinical Oncology Annual Meeting
On May 17, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported new data presentations from multiple studies related to its lead investigational candidate, axicabtagene ciloleucel (also known as KTE-C19), at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, June 2-6, 2017 (Press release, Kite Pharma, MAY 17, 2017, View Source [SID1234519191]). The full text for abstracts is available online through the ASCO (Free ASCO Whitepaper) website at View Source
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“The presentations at ASCO (Free ASCO Whitepaper) continue to enhance our growing knowledge on the potential for cell therapy,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “The translational insights from these data presentations are invaluable as we advance axicabtagene ciloleucel/KTE-C19 and seek to optimize treatment, not only in NHL, but also across a broad range of hematologic malignancies.”
Poster Discussion:
Clinical and biologic covariates of outcomes in ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (r-NHL)
Abstract #7512
Session: Poster Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Board #274
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Poster Discussion Session Time/Location: Monday, June 5, 2017: 1:15-2:30 PM CDT, E354b
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Poster Presentations
Updated results from ZUMA-3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL)
Abstract #3024
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #119
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Bijal D. Shah, M.D., Moffitt Cancer Center, Tampa, FL
Product characteristics associated with in vivo expansion of anti-CD19 CAR T cells in patients treated with axicabtagene ciloleucel (axi-cel)
Abstract #3023
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #118
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Characterization of anti-CD19 chimeric antigen receptor (CAR) T cell-mediated tumor microenvironment immune gene profile in a multicenter trial (ZUMA-1) with axicabtagene ciloleucel (axi-cel, KTE-C19)
Abstract #3025
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #120
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Jerome Galon, Ph.D., Laboratory of Integrative Cancer Immunology, INSERM
ZUMA-6: Phase 1-2 multicenter study evaluating safety and efficacy of axicabtagene ciloleucel (axi-cel; KTE-C19) in combination with atezolizumab in patients with refractory diffuse large B-cell lymphoma (DLBCL)
Abstract #TPS7572
Session: Trials in Progress Poster Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Board #331a
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Online Publication
Total 1-year cost of diffuse large B-cell lymphoma (DLBCL) beyond first-line (1L) therapy: A retrospective cohort analysis
Abstract # e18333
Senior Author: Anna Purdum, PharmD, M.S., Kite Pharma
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, previously known as KTE-C19, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.