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.

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"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.