- 14 avelumab abstracts at ASCO 2016
highlight significant progress being made by the collaboration
between Merck and Pfizer
- Two oral presentations: avelumab
investigated as a second-line treatment for metastatic Merkel cell
carcinoma and in advanced mesothelioma
- Data featured contributes to growing
understanding of the potential role of avelumab in treating a broad
range of cancers
- JAVELIN clinical program rapidly
accelerating
ASCO Abstract #8503, 9508, 4009, 4514, 4516, 9036,
TPS4134, TPS4135, TPS9105, 3055, TPS3106, 5533, TPS5600,
TPS4580
Merck and Pfizer today announced that avelumab* presentations
across seven different tumor types, including two oral
presentations, will be featured at the 52nd 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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About Merck
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work to further develop technologies that improve and enhance life
– from biopharmaceutical therapies to treat cancer or multiple
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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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