In August 2015, AVEO announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody (Company Pipeline, AVEO, MAY 18, 2016, View Source [SID:1234512507]).

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GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Current evidence suggests that a pro- inflammatory state may be responsible for many of the symptoms associated with cachexia, a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions.

Preclinical data show that inhibition of GDF15 results in a switch from catabolism to anabolism, suggesting that GDF15 inhibition with AV-380 may reverse the effects of cachexia.

Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases. It affects some five million individuals in the United States.

On May 18, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the company and its collaborators will have two oral presentations, six poster discussions and nineteen posters presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016 taking place June 3-7 in Chicago (Press release, Foundation Medicine, MAY 18, 2016, View Source [SID:1234512552]).

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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

                  Schedule Your 30 min Free Demo!

The schedule for oral presentations by Foundation Medicine and/or its collaborators is as follows:

Date and Time: Sunday, June 5, 2015 from 9:57 – 10:09 a.m. CT
Title: PD-L1 Expression, Cancer Genome Atlas (TCGA) Subtype and Mutational Load are Independent Predictors of Response to Atezolizumab (atezo) in Metastatic Urothelial Carcinoma (mUC; IMvigor210)
Abstract Number: 104
Location: Hall D1
Session: Immunotherapy: Now We’re Getting Personal – Using Genomics and Biomarkers to Predict Response
Session Type: Clinical Science Symposium
Presenter: Jonathan E. Rosenberg, M.D., medical oncologist, Memorial Sloan Kettering Cancer Center
Collaborator(s): Memorial Sloan Kettering Cancer Center

Date and Time: Sunday, June 5, 2016 from 10:21 – 10:33 a.m. CT
Title: Hybrid Capture-Based Next-Generation Sequencing (HC NGS) in Melanoma to Identify Markers of Response to Anti-PD-1/PD-L1
Abstract Number: 105
Location: Hall D1
Session: Immunotherapy: Now We’re Getting Personal – Using Genomics and Biomarkers to Predict Response
Session Type: Clinical Science Symposium
Presenter: Douglas Buckner Johnson, M.D., M.S.C.I., clinical director, melanoma, Vanderbilt-Ingram Cancer Center
Collaborator(s): Vanderbilt University

The schedule for poster discussions by Foundation Medicine and/or its collaborators is as follows:

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Discussion Time: 3:00 – 4:15 p.m. CT
Title: Genomic Profiling to Distinguish Poorly Differentiated Neuroendocrine Carcinomas Arising in Different Sites
Abstract Number: 4020
Poster Board Number: 12
Poster Display Location: Hall A
Discussion Location: Hall D1
Session: Gastrointestinal (Noncolorectal) Cancer
Presenter: Emily K. Bergsland, M.D., endowed chair in medical oncology, University of California San Francisco
Collaborator(s): University of California San Francisco, Helen Diller Family Comprehensive Cancer Center

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Discussion Time: 3:00 – 4:15 p.m. CT
Title: Total Mutation Burden (TMB) in Lung Cancer (LC) and Relationship with Response to PD-1/PD-L1 Targeted Therapies
Abstract Number: 9017
Poster Board Number: 340
Poster Display Location: Hall A
Discussion Location: E354b
Session: Lung Cancer – Non-Small Cell Metastatic
Presenter: David R. Spigel, M.D., chief scientific officer; director, lung cancer research program; principal investigator, Sarah Cannon Research Institute
Collaborator(s): Sarah Cannon Research Institute

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Discussion Time: 3:00 – 4:15 p.m. CT
Title: Comprehensive Genomic Profiling of 298 Lung Cancers of Varying Histologies Harboring MET Exon 14 Alterations
Abstract Number: 9021
Poster Board Number: 344
Poster Display Location: Hall A
Discussion Location: E354b
Session: Lung Cancer – Non-Small Cell Metastatic
Presenter: Sai-Hong Ignatius Ou, M.D., Ph.D., medical oncologist, Chao Family Comprehensive Cancer Center, University of California Irvine
Collaborator(s): Chao Family Comprehensive Cancer Center, University of California Irvine

Date and Time: Saturday, June 4, 2016 from 1:00 – 4:30 p.m. CT
Discussion Time: 4:45 – 6:00 p.m. CT
Title: Comprehensive Genomic Sequencing (CGS) of 90 Patient Samples of Anaplastic Thyroid Cancer (ATC)
Abstract Number: 6014
Poster Board Number: 336
Poster Display Location: Hall A
Discussion Location: S406
Session: Head and Neck Cancer
Presenter: Saad A. Khan, M.D., medical oncologist, The University of Texas Southwestern Medical Center
Collaborator(s): The University of Texas Southwestern Medical Center

Date and Time: Monday, June 6, 2016 from 8:00 – 11:30 a.m. CT
Discussion Time: 1:15 – 2:30 p.m. CT
Title: Evaluation of Microsatellite Instability (MSI) Status in 11,573 Diverse Solid Tumors using Comprehensive Genomic Profiling (CGP)
Abstract Number: 1523
Poster Board Number: 346
Poster Display Location: Hall A
Discussion Location: S404
Session: Cancer Prevention, Hereditary Genetics and Epidemiology
Presenter: Michael J. Hall, M.D., M.S., associate professor; director, gastrointestinal risk assessment, Fox Chase Cancer Center
Collaborator(s): Fox Chase Cancer Center

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Discussion Time: 4:45 – 6:00 p.m. CT
Title: DNA-Based Genomic Profiling for Classification of Tissue of Origin for Patients with Carcinoma of Unknown Primary Site
Abstract Number: 11519
Poster Board Number: 216
Poster Display Location: Hall A
Discussion Location: S406
Session: Tumor Biology
Presenter: Michael Goldberg, clinical data analyst II cancer genomics, Foundation Medicine

The schedule for poster presentations by Foundation Medicine and/or its collaborators is as follows:

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: Tumor Mutational Burden as a Potential Biomarker for PD-11/PD-L1 Therapy in Colorectal Cancer
Abstract Number: 3587
Poster Board Number: 284
Poster Display Location: Hall A
Session: Gastrointestinal (Colorectal) Cancers
Presenter: Thomas J. George, M.D., F.A.C.P., medical director, gastrointestinal oncology, University of Florida
Collaborator(s): University of Florida

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: Genomic Distinctions Between Colon and Rectal Cancer in Young Patients
Abstract Number: 3574
Poster Board Number: 271
Poster Display Location: Hall A
Session: Gastrointestinal (Colorectal) Cancer
Presenter: Joshua E. Meyer, M.D., assistant professor; residency/fellowship training director, department of radiation oncology, Fox Chase Cancer Center
Collaborator(s): Fox Chase Cancer Center

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: MDM2 Amplification (Amp) to Mediate Cabozantinib Resistance in Patients (Pts) with Advanced RET-Rearranged Lung Cancers
Abstract Number: 9068
Poster Board Number: 391
Poster Display Location: Hall A
Session: Lung Cancer – Non-Small cell Metastatic
Presenter: Romel Somwar, Ph.D., senior research scientist, pathology, Memorial Sloan Kettering Cancer Center
Collaborator(s): Memorial Sloan Kettering Cancer Center

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: Lung-MAP (S1400) Lung Cancer Master Protocol: Accrual, Demographics, and Molecular Markers
Abstract Number: 9088
Poster Board Number: 411
Poster Display Location: Hall A
Session: Lung Cancer – Non-Small Cell Metastatic
Presenter: Vassiliki Papadimitrakopoulou, M.D., professor, department of thoracic/head and neck medical oncology, medical oncology, The University of Texas MD Anderson Cancer Center
Collaborator(s): The University of Texas MD Anderson Cancer Center

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: Emerging genomic landscape and therapeutic targets in young patients with colorectal cancer (CRC).
Abstract Number: 3589
Poster Board Number: 286
Poster Display Location: Hall A
Session: Gastrointestinal (Colorectal) Cancer
Presenter: Christopher Hanyoung Lieu, M.D., director, Colorectal Medical Oncology Program, deputy director, Cancer Clinical Trials Office, University of Colorado
Collaborator(s): University of Colorado

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: Significant Systematic and CNS Activity of the RET Inhibitor Vandetanib Combined with mTOR inhibitor Everolimus in Patients with Advanced NSCLC with RET fusion
Abstract Number: 9069
Poster Board Number: 392
Poster Display Location: Hall A
Session: Lung Cancer – Non-Small Cell Metastatic
Presenter: Tina Cascone, M.D., Ph.D., hematology/oncology fellow, The University of Texas MD Anderson Cancer Center
Collaborator(s): The University of Texas MD Anderson Cancer Center

Date and Time: Saturday, June 4, 2016 from 1:00 – 4:30 p.m. CT
Title: TMPRSS-ERG Fusion in Men with Prostate cancer(PCa) and Non-prostate Malignancies: Defining a role for Comprehensive Genomic Profiling (CGP) to guide Clinical Care
Abstract Number: 5037
Poster Board Number: 294
Poster Display Location: Hall A
Session: Genitourinary (Prostate) Cancer
Presenter: Primo Lara, M.D., associate director for translational research, University of California, Davis
Collaborator(s): University of California, Davis

Date and Time: Saturday, June 4, 2016 from 1:00 – 4:30 p.m. CT
Title: Analysis of Tumor Mutational Burden (TMB) in > 51,000 Clinical Cancer Patients to identify Novel Non-Coding PMS2 Promoter Mutations Associated with increased TMB
Abstract Number: 9572
Poster Board Number: 177
Poster Display Location: Hall A
Session: Melanoma/Skin Cancers
Presenter: Zachary Rockow Chalmers, senior research associate, Foundation Medicine

Date and Time: Saturday, June 4, 2016 from 1:00 – 4:30 p.m. CT
Title: Comprehensive Genomic Profiling of Neuroendocrine Carcinoma of the Prostate
Abstract Number: 5027
Poster Board Number: 284
Poster Display Location: Hall A
Session: Genitourinary (Prostate) cancer
Presenter: Philip J. Stephens, Ph.D., chief scientific officer, Foundation Medicine

Date and Time: Saturday, June 4, 2016 from 1:00 – 4:30 p.m. CT
Title: Deep Sequencing of Metastatic Cutaneous Basal Cell and Squamous Cell Carcinomas to Reveal Distinctive Genomic Profiles and New Routes to Targeted Therapies
Abstract Number: 9522
Poster Board Number: 127
Poster Display Location: Hall A
Session: Melanoma/Skin Cancers
Presenter: Jeffrey S. Ross, M.D., medical director, Foundation Medicine
Collaborator(s): Albany College of Medicine

Date and Time: Saturday, June 4, 2016 from 8:00 – 11:30 a.m. CT
Title: The Genomics of Young Lung Cancer
Abstract Number: 9083
Poster Board Number: 406
Poster Display Location: Hall A
Session: Lung Cancer – Non-Small Cell Metastatic
Presenter: Barbara J. Gitlitz, M.D., associate professor of clinical medicine, University of Southern California Keck School of Medicine
Collaborator(s): University of Southern California Keck School of Medicine

Date and Time: Sunday, June 5, 2016 from 8:00 – 11:30 a.m. CT
Title: Biomarkers of Immune Checkpoint Inhibitor Response in Metastatic Breast Cancer: PD-L1 Protein Expression, CD274 Gene Amplification, and Total Mutational Burden
Abstract Number: 3057
Poster Board Number: 379
Poster Display Location: Hall A
Session: Developmental Therapeutics and Translational Research
Presenter: Jeffrey S. Ross, M.D., medical director, Foundation Medicine
Collaborator(s): Albany College of Medicine

Date and Time: Monday, June 6, 2016 from 8:00 – 11:30 a.m. CT
Title: Distinct Age-Associated Genomic Profiles Identified in Acute Myeloid Leukemia (AML) Using FoundationOne Heme
Abstract Number: 7041
Poster Board Number: 33
Poster Display Location: Hall A
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Katherine Tarlock, M.D., acting instructor, hematology-oncology, Seattle Children’s Hospital
Collaborator(s): Fred Hutchinson Cancer Research Center

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Comparison of Upper Tract Urothelial Carcinoma and Urothelial Carcinoma of the Bladder to Reveal Key Differences in Mutational Profile and Load
Abstract Number: 4522
Poster Board Number: 145
Poster Display Location: Hall A
Session: Genitourinary (Nonprostate) Cancer
Presenter: Sumanta K. Pal, M.D., assistant clinical professor, department of medical oncology & therapeutics research, City of Hope
Collaborator(s): City of Hope

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Assessment of Tumor Mutation Burden from > 60,000 Clinical Cancer Patients Using Comprehensive Genomic Profiling
Abstract Number: 11558
Poster Board Number: 255
Poster Display Location: Hall A
Session: Tumor Biology
Presenter: Garrett Michael Frampton, Ph.D., associate director, bioinformatics, Foundation Medicine

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Immunotherapy (IO) Versus Targeted Therapy Triage in Advanced Endometrial Adenocarcinoma (aEA) by Coordinate Assessment Tumor Mutation Burden (TMB), Microsatellite Instability (MSI) Status, and Targetable Genomic Alterations (GA)
Abstract Number: 5591
Poster Board Number: 414
Poster Display Location: Hall A
Session: Gynecologic Cancer
Presenter: Alessandro Santin, M.D., professor of obstetrics, gynecology and reproductive sciences; clinical research program leader, gynecologic oncology program, Yale School of Medicine
Collaborator(s): Yale School of Medicine

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Comprehensive Genomic Profiling to Identify Clinically Relevant Genomic Alterations in Patients with Advanced Penile Cancers
Abstract Number: 4573
Poster Board Number: 195
Poster Display Location: Hall A
Session: Genitourinary (Nonprostate) Cancer
Presenter: Andre Poisl Fay, M.D.
Collaborator(s): Pontifícia Universidade Católica do Rio Grande do Sul School of Medicine

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Decision Impact Analysis of Comprehensive Genomic Profiling (CGP) in Advanced Breast Cancer: A Prospective Study
Abstract Number: 11578
Poster Board Number: 275
Poster Display Location: Hall A
Session: Tumor Biology
Presenter: Raquel E. Reinbolt, M.D., assistant professor, internal medicine, college of medicine, The Ohio State University
Collaborator(s): The Ohio State University Medical Center James Comprehensive Cancer Center

Date and Time: Monday, June 6, 2016 from 1:00 – 4:30 p.m. CT
Title: Investigating the Utility of Comprehensive Genomic Profiling for Patients with Newly Diagnosed Breast Cancer
Abstract Number: TPS11617
Poster Board Number: 312b
Poster Display Location: Hall A
Session: Tumor Biology
Presenter: Casey B. Williams, Pharm.D., BCOP, director, molecular and experimental medicine, Avera Health
Collaborator(s): Avera Cancer Institute

On May 18, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five abstracts at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, June 3 to June 7, 2016, in Chicago (Press release, TESARO, MAY 18, 2016, View Source [SID:1234512599]). In addition, TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting.

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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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"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. Because symptoms occur outside the clinic, patients don’t always report their experiences with delayed CINV. The two post-hoc analyses to be presented highlight increased control of CINV for patients who received VARUBI while being treated with chemotherapy for gynecologic and breast cancers," said Mary Lynne Hedley, Ph.D., President and COO, TESARO. "In addition, posters describing currently ongoing studies, including a Phase 1 trial of niraparib plus bevacizumab in patients with ovarian cancer (AVANOVA), a Phase 1 trial of niraparib plus pembrolizumab in patients with triple-negative or recurrent ovarian cancer (KEYNOTE-162) and a Phase 3 trial of niraparib as a maintenance therapy in patients who have responded to first-line, platinum-based chemotherapy (PRIMA) will be presented."

Please visit TESARO at Booth #14159 for information about VARUBI and our pipeline. TESARO will also be providing information on homologous recombination deficiency (HRD) and ovarian cancer at Booth #21047.

Presentation Details:

(VARUBI) Rolapitant

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer.
Abstract: 10121, Poster Board: 109, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.
Abstract: 10122, Poster Board: 110, Location: S Hall A

Niraparib

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A phase 1 study of bevacizumab in combination with niraparib in patients with platinum-sensitive epithelial ovarian cancer: The ENGOT-OV24/AVANOVA1 trial.
Abstract #5555, Poster Board #378, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Phase 1/2 study of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent ovarian cancer (KEYNOTE-162).
Abstract #TPS5599, Poster Board #421a, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A randomized, double-blind phase 3 trial of niraparib maintenance treatment in patients with HRD+ advanced ovarian cancer after response to front-line platinum-based chemotherapy.
Abstract #TPS5606, Poster Board #424b, Location: S Hall A

Niraparib is an investigational product candidate that has not been approved by any regulatory agencies.

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting. At this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

On May 18, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer reported that avelumab* presentations across seven different tumor types, including two oral presentations, will be featured at the 52nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3–7, 2016, in Chicago, IL (Press release, Merck KGaA, MAY 18, 2016, View Source;newsType=1 [SID:1234512553]). The avelumab presentations, from the rapidly accelerating JAVELIN clinical development program, include new study results from a number of difficult-to-treat cancers, including data from the pivotal Phase II trial of avelumab being investigated as second-line treatment for metastatic Merkel cell carcinoma (MCC). Additional data include highlights from mesothelioma, adrenocortical carcinoma, non-small cell lung cancer, and urothelial bladder, gastric and ovarian cancers, as well as updated safety data.

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!

"One of our key highlights for ASCO (Free ASCO Whitepaper) will be the new avelumab data in second-line metastatic Merkel cell carcinoma," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "As there are currently no approved treatments for this rare and aggressive cancer, these clinically meaningful data represent a breakthrough for this difficult-to-treat tumor type."

Since ASCO (Free ASCO Whitepaper) 2015, the collaboration between Merck KGaA, Darmstadt, Germany, and Pfizer has made significant progress. The JAVELIN development program for avelumab now includes 30 ongoing clinical programs and nine pivotal studies. As of May 2016, JAVELIN now includes approximately 2,200 patients, being treated across more than 15 tumor types.

"These data add to the growing body of evidence for avelumab, indicating efficacy and a favorable safety profile in multiple cancers, which supports ongoing development," said Chris Boshoff, M.D., PhD., Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology. "Through our comprehensive JAVELIN clinical development program for avelumab, we are making meaningful advances for a broad range of patients with cancer."

Avelumab is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand. As a checkpoint inhibitor, avelumab is thought to have a dual mechanism of action which is believed to enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO (Free ASCO Whitepaper) website.

Title Lead Author
Abstract
ID /
Poster
No.

Presentation
Date / Time
Session
Oral Presentations
Mesothelioma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Hassan R
Abstract
ID: 8503

Sunday, June 5
8:00 a.m. CDT
Arie Crown Theater

Lung Cancer –
Metastatic
Disease
Merkel Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: results of the Phase II JAVELIN Merkel 200 trial
Kaufman H
Abstract
ID: 9508

Monday, June 6
1:15 p.m. CDT
Arie Crown Theater

Melanoma/Skin
Cancers
Poster Discussions
Gastric/Gastro-esophageal
Junction Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity
Chung HC
Abstract
ID: 4009
Poster No.: 1

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Urothelial Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity, and PD-L1 expression
Apolo A
Abstract ID:
4514
Poster
No.: 137

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Adrenocortical Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced adrenocortical carcinoma from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Le Tourneau C
Abstract
ID: 4516
Poster
No.: 138

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Poster Presentations
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Verschraegen C
Abstract
ID: 9036
Poster
No.: 359

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer –
Non-Small Cell
Metastatic
Gastric Cancer
Maintenance therapy with avelumab (MSB0010718C; anti-PD-L1) vs continuation of first-line chemotherapy in patients with unresectable, locally advanced or metastatic gastric cancer: the Phase III JAVELIN Gastric 100 trial
Moehler M
Abstract ID:
TPS4134
Poster No.:
124b

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Gastric Cancer
Avelumab (MSB0010718C; anti-PD-L1) + best supportive care (BSC) vs BSC ± chemotherapy as third-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial
Bang Y-J
Abstract ID:
TPS4135
Poster No.:
125a

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) vs platinum-based doublet as first-line treatment for metastatic or recurrent PD-L1–positive non-small-cell lung cancer: the Phase III JAVELIN Lung 100 trial
Reck M
Abstract ID:
TPS9105
Poster No.:
425a

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer—
Non‐Small Cell
Metastatic
Advanced Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer: safety data from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor trial
Kelly K
Abstract ID:
3055
Poster No.:
377

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Advanced Malignancies
Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN Medley study
Ribas A
Abstract ID:
TPS3106
Poster No.:
422b

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian cancer from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Disis ML
Abstract ID:
5533
Poster No.:
356

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) ± pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200 trial
Pujade Lauraine E
Abstract ID:
TPS5600
Poster No.:
421b

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Renal Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in combination with axitinib as first-line treatment for patients with advanced renal cell carcinoma
Larkin J
Abstract ID:
TPS4580
Poster No.:
199a

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer

*Avelumab is the proposed nonproprietary name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

On May 19, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter called "Sumitomo Dainippon Pharma") reported that clinical data of napabucasin (BBI608) and amcasertib (BBI503) will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3 to June 7, 2016 (Press release, Dainippon Sumitomo Pharma, MAY 18, 2016, View Source [SID:1234512577]).

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Napabucasin: 6 presentations
1. ABSTRACT #3564, Poster #261: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-246: NCT02024607: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC). The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

2. ABSTRACT #4128, Poster #120: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-118: NCT02231723: A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

3. ABSTRACT #9093, Poster #416: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

4. ABSTRACT #1094, Poster #199: Sunday, June 5 from 8:00 a.m. – 11:30 a.m.:BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer. 2 The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

5. ABSTRACT #5578, Poster #401: Monday, June 6 from 1:00 p.m. – 4:30 p.m.:BBI608-118: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

6. ABSTRACT #TPS4144, Poster #129b: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.:BBI608-336: NCT02178956: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

Amcasertib: 1 presentation
1. ABSTRACT #6018, Poster #340: Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Poster Session) Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session):BBI503-101: NCT01781455: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)