Merck and Pfizer to Present Avelumab Data in Seven Different Cancers at ASCO Annual Meeting
DARMSTADT, Germany & NEW YORK–(BUSINESS WIRE)– Merck and Pfizer today announced that avelumab* presentations across seven different tumor types, including two oral presentations, will be featured at the 52 nd American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3–7, 2016, in Chicago, IL. 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.
“One of our key highlights for ASCO will be the new avelumab data in second-line metastatic Merkel cell carcinoma,” said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. “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 2015, the collaboration between Merck 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 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 and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
About Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab, as a monotherapy, as well as combination regimens, and is striving to find new ways to treat cancer.
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Pfizer Disclosure Notice
The information contained in this release is as of May 18, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about avelumab (MSB0010718C), the potential of immuno-oncology, Pfizer’s and Merck’s immuno-oncology alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any jurisdictions for any potential indications for avelumab, combination therapies or other product candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of avelumab, combination therapies or other product candidates; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
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