On May 18, 2017 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that data on the correlation between gene mutation clearance and clinical response from a Phase II clinical study of Pracinostat and azacitidine in older patients with acute myeloid leukemia (AML) have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on Monday, June 5, 2017, and the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Madrid on Friday, June 23, 2017 (Press release, MEI Pharma, MAY 18, 2017, View Source [SID1234519214]). Abstracts of the presentations are now available at abstracts.asco.org and www.ehaweb.org.

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ASCO
Title: Correlation between Mutation Clearance and Clinical Response in Elderly Patients with Acute Myeloid Leukemia (AML) Treated with Azacitidine and Pracinostat
Abstract Number: 7034
Session Title: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes and Allotransplant
Date and Time: Monday, June 5, 2017, 8:00 a.m. – 11:30 a.m. CDT (9:00 a.m. – 12:30 p.m. EDT)

EHA
Title: Treatment of Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML): Correlation between Mutation Clearance and Clinical Response
Abstract Code: P207
Session Title: Acute Myeloid Leukemia – Clinical 2
Date and Time: Friday, June 23, 17:15 – 18:45 CEST (1:15 p.m. – 2:45 p.m. EDT)

About Pracinostat
Pracinostat is a potential best-in-class, oral histone deacetylase (HDAC) inhibitor that is in late stage clinical development. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In August 2016, Helsinn and MEI Pharma entered into an exclusive license, development and commercialization agreement for Pracinostat in AML and other potential indications. The deal provides the complementary resources from both organizations to rapidly advance Pracinostat into Phase III clinical development and expand into additional areas of clinical development, including high-risk myelodysplastic syndrome (MDS). Pracinostat is an investigational agent and is not approved for use in the U.S.

About AML
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to continue to increase as the population ages. The American Cancer Society estimates about 21,380 new cases of AML per year in the U.S., with an average age of about 67 years. Front line treatment consists primarily of induction chemotherapy, while the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology recommend hypomethylating agents azacitidine or decitabine as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.

On May 18, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that data from its suite of comprehensive genomic profiling (CGP) assays, including FoundationOne, FoundationACT liquid biopsy, FoundationOne Heme, and FoundationFocus CDxBRCA will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, 2017 in Chicago (Press release, Foundation Medicine, MAY 18, 2017, View Source [SID1234519213]).

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The company and its collaborators will present a total of 33 studies at the meeting, including two oral presentations, eight poster discussions and twenty-three posters, ranging across 15 different tumor types. Data demonstrate the impact of tissue- and blood-based CGP on guiding targeted therapy, immunotherapy, or clinical trial decisions in advanced cancers. In addition, the clinical value of CGP as evidenced through real world evidence and outcomes research (HEOR) studies, as well as data highlighting the ability of CGP to accelerate clinical trial enrollment will be presented.

"Together these studies highlight the importance of our CGP approach in advancing precision medicine in cancer care and build upon the growing body of evidence supporting its use in clinical practice," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Previous findings from Foundation Medicine have shown that measuring tumor mutational burden (TMB) with FoundationOne can predict responses to FDA-approved anti-PD-1/anti-PD-L1 immunotherapies across multiple tumor types. New results will be presented at this year’s ASCO (Free ASCO Whitepaper) which help describe the landscape of TMB in triple-negative breast cancer, ovarian cancer, metastatic melanoma, biliary tract cancer and cancer of unknown primary, pointing to potentially new subsets of patients who may benefit from this therapeutic strategy. We believe these data will be critical to advancing the field of immunotherapy, and will be particularly insightful for clinicians, as well as biopharma companies seeking to advance immunotherapeutic agents. In addition, we’ll present exciting new data demonstrating the impact of our decision support tools on accelerating clinical trial enrollment – – helping to address an important need in cancer care."

New results include an oral presentation titled "Comprehensive genomic profiling with loss of heterozygosity to identify therapeutically relevant subsets of ovarian cancer," which shows that CGP can reveal molecular, rather than histologic, patient subsets who may benefit from poly (ADP-ribose) polymerase (PARP) inhibitor targeted therapy or immunotherapy. These results also provide support for insurance coverage and further integration of CGP into clinical trials in ovarian cancer.

Further supporting the integration of CGP at diagnosis, results from health economic and outcomes studies will be presented, demonstrating that early integration of CGP into a patient’s clinical and diagnostic work-up leads to improved patient outcomes associated with reasonable incremental costs to the payer that are largely driven by increased survival time on treatment. One poster titled "Estimated Cost of Anti-Cancer Therapy Directed by CGP in a Single-Center Study" discusses estimated anti-cancer drug costs and the associated cost impact of overall survival (OS) for matched vs. unmatched therapy in patients enrolled in a previously reported clinical trial using FoundationOne to guide therapeutic decisions.

In addition, important new studies will be presented on the ability of FoundationACT liquid biopsy assay to identify ESR1 and PIK3CA mutations in metastatic breast cancer, acquired resistance mutations in non-small cell lung cancer and BRCA1/2 reversion mutations in prostate cancer, all of which could help guide treatment decisions for these indications.

Other studies demonstrate the ability of CGP to accelerate clinical trial enrollment. Results from "Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and ‘Just-in-Time’ clinical trial sites: An index case of a paradigm shift", reveal a new approach for matching patients to clinical trials that focus on rare genomic findings. Combined with a computational matching infrastructure, this approach could accelerate drug development and improve access to novel targeted therapies.

Following is a list of selected abstracts, including those referenced above.

Visit View Source for a complete list of abstracts and to stay connected with Foundation Medicine during the ASCO (Free ASCO Whitepaper) meeting.

Immunotherapy/TMB Data

Oral Presentation: Abstract 5512 – Comprehensive genomic profiling (CGP) with loss of heterozygosity (LOH) to identify therapeutically relevant subsets of ovarian cancer (OC), June 5, E450ab, 8:48am – 9:00am
Abstract 9536 – Landscape of genomic alterations (GA) and tumor mutational burden (TMB) in different metastatic melanoma (MM) subtypes, June 3, Hall A, 1:15pm – 4:45pm
Abstract 4086 – Tumor mutational burden (TMB) and co-existing actionable mutations in biliary tract cancers (BTC), June 3, Hall A, 8:00am – 11:30am
Abstract 3039 – Mutational burden of tumors with primary site unknown, June 5, Hall A, 8:00 am – 11:30am
Abstract 9072 – BRAF fusions in clinically advanced non-small cell lung cancer: An emerging target for anti-BRAF therapies, June 3, Hall A, 8:00am – 11:30am
Targeted Therapy Data

Oral Presentation: Abstract 11001 – Impact of next-generation sequencing (NGS) on diagnostic and therapeutic options in soft-tissue and bone sarcoma, June 2, S100bc, 3:12pm – 3:24pm
Abstract 3583 – Targeted therapy for HER2 driven colorectal cancer, June 3, Hall A, 8:00am – 11:30am
Health Economic Data

Abstract 6599 – Comprehensive genomic profiling (CGP) versus conventional molecular diagnostic testing of patients with advanced non-small cell lung cancer (NSCLC): Overall survival (OS) and cost in US health plan population, June 5, Hall A, 1:15pm – 4:45pm
Abstract 6605 – Estimated cost of anti-cancer therapy directed by comprehensive genomic profiling (CGP) in a single-center study, June 5, Hall A, 1:15pm – 4:45pm
Liquid Biopsy Data

Abstract 1016 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with metastatic breast cancer (mBC), June 4, Hall B1, 4:45pm – 6:00pm
Abstract 9025 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with advanced non-small cell lung cancer (NSCLC), June 3, Hall A, 8:00am – 11:30am
Abstract 5024 – BRCA1/2 reversion mutations in prostate cancer identified from clinical tissue and liquid biopsy samples, June 5, Hall A, 1:15pm – 4:45pm
Abstract 4128 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with pancreatic ductal adenocarcinoma (PDA), June 3, Hall A, 8:00am – 11:30am
Clinical Trial and Partnerships Data

Abstract 6539 – Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and just-in-time clinical trial sites: An index case of a paradigm shift, June 5, Hall A, 1:15pm – 4:45pm
Abstract 2512 – Personalized, molecularly matched combination therapies for treatment-naïve, lethal malignancies: The I-PREDICT study, June 5, Arie Crown Theater, 11:30am – 12:45pm

On May 18, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported positive interim data on its first-in-class EZH2 inhibitor, tazemetostat, from the epithelioid sarcoma cohort of its ongoing Phase 2 study in adult patients with molecularly defined solid tumors (Press release, Epizyme, MAY 18, 2017, View Source [SID1234519211]). In addition, the Company announced that it recently conducted a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss the registration strategy for tazemetostat for the treatment of epithelioid sarcoma. Based on discussions with the FDA, the Company has identified a path to submission for accelerated approval of tazemetostat based on the 60-patient cohort from its Phase 2 study, and will target a New Drug Application (NDA) submission in 2018.

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An interim assessment of the epithelioid sarcoma cohort of patients (n=31), as of May 1, 2017, shows that treatment with tazemetostat resulted in a 32 percent disease control rate and a 13 percent overall response rate, with a median duration of response of seven months and ongoing. In addition, tazemetostat continues to demonstrate a favorable safety profile.

"Epithelioid sarcoma is a difficult cancer for sarcoma oncologists like me to treat due to there being few available therapeutic options, which are associated with limited benefit and challenging side effects for patients," said Mrinal M. Gounder, M.D., attending physician at Memorial Sloan Kettering Cancer Center and lead investigator in the Phase 2 clinical trial. "INI1 loss is a defining feature of epithelioid sarcoma and the mechanism of tazemetostat makes this a compelling agent. These data show encouraging activity of tazemetostat as characterized by objective responses, duration of responses and prolonged disease stabilization, and I look forward to its continued development."

"Bringing tazemetostat to patients is our number one priority," said Robert Bazemore, president and chief executive officer of Epizyme. "We stand today with a line of sight to an expedited pathway of bringing tazemetostat to patients with this rare and devastating form of cancer. I am very proud of the hard work and dedication of the entire Epizyme team in advancing tazemetostat this far, so that we may provide a new treatment option to patients who are in desperate need of effective and tolerable medicines."

Phase 2 Study in Molecularly Defined Solid Tumors
Epizyme’s Phase 2 study is evaluating the efficacy and safety of 800mg of tazemetostat orally administered twice-daily in adult patients with certain molecularly defined solid tumors, stratified into five different cohorts based on tumor type, including: epithelioid sarcoma, synovial sarcoma, malignant rhabdoid tumor, renal medullary carcinoma and other INI1-negative tumors.

Epizyme will present interim efficacy data from the epithelioid sarcoma and synovial sarcoma cohorts and safety data from all cohorts at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The remaining three arms of the study have not yet reached futility assessment by the Independent Data Monitoring Committee. Epizyme anticipates providing updates from those cohorts later in 2017.

Epithelioid Sarcoma Efficacy Data
The epithelioid sarcoma cohort in Epizyme’s Phase 2 study represents the largest prospective study of epithelioid sarcoma with any approved or investigational treatment to date. Epithelioid sarcoma is an ultra-rare and aggressive soft tissue sarcoma, characterized by a loss of the INI1 protein. It is most commonly diagnosed in young adults (20-40 years old) and is often fatal. There is no established standard-of-care for treating these patients, who are typically resistant to chemotherapy.

The cohort was initially designed to enroll 30 patients, and was expanded to enroll an additional 30 patients in December 2016 based on encouraging early activity. The cohort has enrolled 49 front-line and relapsed or refractory epithelioid sarcoma patients out of a projected total of 60 patients. Interim data to be presented are from 31 patients in the initial study group, as of the data cutoff on May 1, 2017.

In these patients, tazemetostat treatment resulted in a 32 percent disease control rate (DCR), the primary endpoint. DCR is comprised of confirmed objective responses by RECIST 1.1 for any duration or disease stabilization of 32 weeks or more. Thus far, four patients (13%) have achieved confirmed objective responses (all partial), and the time to response ranged from two months to six months. The median duration of response is seven months and ongoing. Prolonged disease stabilization of 32 weeks or more has been observed in six patients (19%), including two patients having stable disease for more than 15 months. These Phase 2 data complement the Company’s experience from its Phase 1 study, in which two of three patients with epithelioid sarcoma remain on tazemetostat with stable disease out over two years.

A median progression-free survival (PFS) of 5.7 months has been observed, and initial assessment of overall survival for those patients in the DCR group compared to the non-DCR group showed distinct separation in survival curves, favoring the DCR group. The data from this cohort are still maturing, and an initial assessment suggests the potential for prolonged clinical benefit with tazemetostat treatment.

These interim data will be presented at ASCO (Free ASCO Whitepaper) by Dr. Gounder in a poster titled "Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with INI1 negative epithelioid sarcoma (NCT02601950)" on June 4 (Abstract No.: 11058, Poster Board No.: 381).

Tazemetostat Safety Profile
Tazemetostat has demonstrated a favorable safety profile in the Phase 2 study, particularly when considering the adverse effects associated with currently utilized chemotherapeutic regimens and other STS therapies. Safety data from patients in all study cohorts (n=121) are consistent with the overall safety profile observed in a nearly 400 patient-safety database from tazemetostat clinical trials to date, showing favorable tolerability without significant safety events. There were no discontinuations due to adverse events in any of the study cohorts. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2, with only 12 percent of patients experiencing grade 3 or higher treatment-related TEAEs. Reported TEAEs regardless of attribution with an incidence of 10 percent or greater were fatigue (34%), dyspnea and nausea (27% each), cough (22%), decreased appetite (20%), vomiting (19%), constipation (18%), anemia (17%), diarrhea (16%), back pain and headache (12% each), pleural effusion (11%) and death and peripheral edema (10% each). All deaths that occurred during the study were attributed to the patients’ underlying disease and not to treatment with tazemetostat.

There were no clinically relevant differences in the safety profile for either the epithelioid sarcoma or the synovial sarcoma cohorts compared to that of the entire study.

Synovial Sarcoma Efficacy Data
The cohort of patients with synovial sarcoma (n=33) in the Phase 2 study completed enrollment in November 2016. Data show tazemetostat treatment resulted in stable disease as the best response in 10 patients (30%) with five patients (15%) meeting the primary endpoint of disease stabilization for 16 weeks or longer. The level of activity was determined to be insufficient to advance tazemetostat as a monotherapy for this tumor type.

These data will be presented in a poster by Patrick Schöffski, M.D., Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospitals Leuven, KU Leuven, Belgium, titled "Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with synovial sarcoma (NCT02601950)" on June 4 (Abstract No.: 11057, Poster Board No.: 380).

Conference Call Information
Epizyme will host a conference call and audio webcast today at 8:30 a.m. Eastern Time. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 12186629. The webcast, and accompanying slides for the call, can be accessed under "Events and Presentations" in the Investor Relations section of the company’s website at www.epizyme.com.

About Epithelioid Sarcoma
Epithelioid sarcoma is an ultra-rare soft tissue sarcoma characterized by a loss of function of the protein INI1. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age. Median overall survival from initial diagnosis is 30 months. Epithelioid sarcoma becomes more aggressive after recurrence or metastases, with a typical survival of eight to 12 months for patients with metastatic disease. There is no approved treatment indicated specifically for epithelioid sarcoma, and there is no established standard of care.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma; and mesothelioma; as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for both relapsed/refractory follicular lymphoma with or without an EZH2 activating mutation and DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.

On May 18, 2017 ArQule, Inc. (Nasdaq: ARQL) reported that preclinical data for ARQ 531 in diffuse large B-cell lymphoma (DLBCL) in vitro and in vivo tumor models will be presented on June 23, 2017 at EHA (Free EHA Whitepaper) Congress in Madrid, Spain (Press release, ArQule, MAY 18, 2017, View Source [SID1234519210]). The data supports clinical trials with ARQ 531 in the ibrutinib resistant patient population. A phase 1 trial with ARQ 531 in patients with B-cell malignancies refractory to other therapeutic options, including ibrutinib, is planned to commence by the third quarter of 2017. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK).

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Presentation Details

Friday, June 23, 2017: Non-Hodgkin and Hodgkin Lymphoma – Biology

ARQ 531
Abstract E1400
ARQ 531, a reversible BTK inhibitor, demonstrates potent anti-tumor activity in ABC-DLBCL and GCB-DLBCL
E-poster Screens
Time: 9:30 AM CET

About BTK and ARQ 531

ARQ 531 is an investigational, orally bioavailable, potent and reversible Bruton’s tyrosine kinase (BTK) inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S mutation is a known emerging resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies ARQ 531 has demonstrated high oral bioavailability as well as good ADME, pharmacokinetic and metabolic properties. The company plans to initiate a phase 1 trial by the third quarter of 2017. BTK is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers.

On May 18, 2017 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic diseases, reported that updated clinical data from the fully enrolled, ongoing Phase 2 study (DRIVE PK) of AG-348 in adults with pyruvate kinase (PK) deficiency, a rare, potentially debilitating, congenital anemia, will be presented at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain. AG-348 is a wholly owned, novel, first-in-class, oral activator of both wild-type (normal) and mutated pyruvate kinase-R (PKR) enzymes (Press release, Agios Pharmaceuticals, MAY 18, 2017, View Source [SID1234519209]).

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The accepted abstracts are listed below and available online on the EHA (Free EHA Whitepaper) conference website: View Source!*listing=3*browseby=2*sortby=1*media=3*ce_id=1181*label=15531

Oral presentation by Agios:

Title: Effects of AG-348, a pyruvate kinase activator, in patients with Pyruvate Kinase Deficiency: updated results from the DRIVE-PK study
Date & Time: Saturday, June 24, 2017 from 11:30-11:45 a.m. CET
Session Title: Sickle cell disease, enzymes
Abstract Code: S451
Location: Room N109
Presenter: Rachael Grace, M.D., Dana-Farber Boston Children’s Cancer and Blood Disorder Center
Updated data from the DRIVE PK study will be presented at the time of the meeting.

Poster presentation by Agios collaborator:

Title: Ex-vivo treatment of red blood cells from 15 Pyruvate Kinase (PK)-deficient patients with AG-348, an allosteric activator of PK-R, increases enzymatic activity, protein stability and ATP levels
Date & Time: Saturday, June 24, 2017 from 5:30-7:00 p.m. CET
Session Title: Enzymes and sickle cell disease
Abstract Code: P614
Location: Poster area (Hall 7)
Author: Richard van Wijk, Ph.D., University Medical Center Utrecht

Encore presentations 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: Saturday, June 24, 2017 from 4:00-4:15 p.m. CET
Oral Abstract Session: Targeted treatment of AML
Abstract Code: S471
Location: Hall D
Presenter: Eytan Stein, 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: Friday, June 23, 2017 from 5:15-6:45 p.m. CET
Session Title: Acute myeloid leukemia – Clinical 3
Abstract Code: P215
Location: Poster area (Hall 7)
Author: Amir Tahmasb Fathi, M.D., Massachusetts General Hospital and Harvard Medical School

About Agios
Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutic areas, Agios has multiple first-in-class investigational medicines in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics. For more information, please visit the company’s website at www.agios.com.

About Agios/Celgene Collaboration
IDHIFA (enasidenib) and AG-881 are part of Agios’ global strategic collaboration with Celgene Corporation focused on cancer metabolism. Under the terms of the 2010 collaboration agreement, Celgene has worldwide development and commercialization rights for IDHIFA (enasidenib). Agios continues to conduct clinical development activities within the IDHIFA (enasidenib) development program and is eligible to receive reimbursement for those development activities and up to $95 million in remaining payments assuming achievement of certain milestones and royalties on net sales. Celgene and Agios intend to co-commercialize IDHIFA (enasidenib) in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts.