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Merck and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017

Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media

- A total of 13 abstracts across seven hard-to-treat cancers 
  highlight the progress of avelumab as a monotherapy and potential 
  novel combination treatment option  
- New data in metastatic Merkel cell carcinoma and previously treated
  metastatic urothelial carcinoma, following recent US FDA 
  accelerated approvals  

Merck and Pfizer today announced that 13 avelumab* abstracts across seven challenging tumor types will be featured at the 53rd American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6, 2017 in Chicago, IL. Key presentations include data for avelumab in first-line metastatic Merkel cell carcinoma (mMCC) and in previously treated metastatic urothelial carcinoma (UC), as well as results from the Phase Ib trial investigating avelumab in combination with the tyrosine kinase inhibitor axitinib, in advanced renal cell carcinoma (RCC).

(Logo: http://mma.prnewswire.com/media/477506/Merck_Pfizer_Logo.jpg )

"Our ASCO presence adds to what has already been a momentous year for the alliance, coming shortly after the US FDA granted two accelerated approvals for avelumab," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck, which in the US and Canada operates as EMD Serono. "We're particularly excited to share the latest avelumab data in both metastatic Merkel cell carcinoma in the first-line setting and previously treated metastatic urothelial carcinoma with the cancer community."

"Our data at ASCO this year underscore the potential of avelumab as a monotherapy treatment, as well as part of combination regimens," said Chris Boshoff, M.D., PhD, Senior Vice President and Head of Immuno-Oncology, Early Development, Translational Oncology, Pfizer Global Product Development. "Now with accelerated approvals in two indications for avelumab in the US, we are entering the next chapter of our clinical development program to provide meaningful new treatment options for patients who need them most."

Highlights of avelumab data at ASCO 2017 include the following:

- Preliminary data from the ongoing JAVELIN Merkel 200 trial, an 
  open-label, multicenter study conducted in first-line mMCC 
  investigating avelumab in patients who had no prior systemic 
  treatment for mMCC, will be presented for the first time at a 
  medical congress.
- Data from a pooled analysis of two metastatic UC cohorts of the 
  JAVELIN Solid Tumor trial, a Phase Ib, open-label, single-arm, 
  multicenter study of avelumab in the treatment of various solid 
  tumors, will be presented.
- An oral presentation of results from the JAVELIN Renal 100 trial, a
  Phase Ib, open-label study evaluating the clinical activity and 
  safety of the combination of avelumab and axitinib for the 
  first-line treatment of advanced RCC.
- Beyond mMCC, metastatic UC and RCC, the Merck-Pfizer Alliance will 
  also showcase avelumab abstracts in non-small cell lung cancer, 
  metastatic castrate-resistant prostate cancer, locally advanced 
  squamous cell carcinoma of the head and neck and relapsed or 
  refractory diffuse large B-cell lymphoma, as well as updated safety
  data in solid tumors. 

The alliance's rapidly accelerating JAVELIN clinical development program now involves at least 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types. Results from JAVELIN program trials have supported two FDA accelerated approvals in 2017.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO website (https://am.asco.org/).




Abstract ID /     Presentation
Title                Lead Author  Poster No.         Date / Time 
Session
Oral Presentations

Renal Cell           Choueiri TK          4504    Monday, June 5 
Genitourinary
Carcinoma                                        8:00-11:00 a.m. 
(Nonprostate) Cancer
(JAVELIN Renal
100)

First-line
avelumab +
axitinib therapy
in patients with                  
advanced renal
cell carcinoma:
results from a                                                  
phase 1b trial                

Poster Sessions

Head and Neck             Lee NY       TPS6093    Monday, June 5 
Head and Neck Cancer
Cancer (TiP)                                      1:15-4:45 p.m.
(JAVELIN Head and
Neck 100)

JAVELIN Head and
Neck 100: a phase
3 trial of
avelumab in
combination with
chemoradiotherapy
(CRT) vs CRT for
1st-line
treatment of
locally advanced                           
squamous cell
carcinoma of the
head and neck (LA
SCCHN)              

Lymphoma (TiP)            Chen R      TPS7575    Monday, June 5  
Hematologic
(JAVELIN DLBCL)                                 8:00-11:30 a.m.  
Malignancies-Lymphoma

and Chronic Lymphocytic
Phase 1b/3 study                                                 
Leukemia
of avelumab-based
combination                                                      
regimens in                                                 
patients (pts)                                             
with relapsed or                           
refractory
diffuse large
B-cell lymphoma
(R/R DLBCL)

Merkel Cell          D'Angelo SP        9530  Saturday, June 3   
Melanoma/Skin Cancers
Carcinoma                                       1:15-4:45 p.m.
(JAVELIN Merkel
200)

First-line
avelumab
treatment in
patients with
metastatic Merkel                         
cell carcinoma:
preliminary data
from an ongoing
study

Merkel Cell            Shapiro I        9557  Saturday, June 3  
Melanoma/Skin Cancers
Carcinoma                                       1:15-4:45 p.m.
(JAVELIN Merkel
200)

Exploratory
biomarker
analysis in
patients with
chemotherapy-
refractory metastatic
Merkel cell
carcinoma treated
with avelumab           

Non-Small Cell         Gulley JL        9086  Saturday, June 3   
Lung Cancer-Non-Small
Lung Cancer                                    8:00-11:30 a.m.   
Cell Metastatic
(JAVELIN Solid
Tumor)

Exposure-response
and PD-L1
expression
analysis of
second-line
avelumab in
patients with
advanced NSCLC:
data from the
JAVELIN Solid                                               
Tumor trial

Pan-Tumor                Kelly K        3059    Monday, June 5   
Developmental
(JAVELIN Solid                                 8:00-11:30 a.m.   
Therapeutics-
Tumor)                                                           
Immunotherapy

Safety profile of
avelumab in
patients with
advanced solid
tumors: a JAVELIN
pooled analysis                                                 
of phase 1 and 2                                           
data

Prostate Cancer   Fakhrejahani F        5037    Monday, June 5   
Genitourinary
(JAVELIN Solid                                    1:15-4:45 PM   
(Prostate) Cancer
Tumor)

Avelumab in
metastatic
castration-resist
ant prostate                                        
cancer (mCRPC)                   

Renal Cell           Choueiri TK      TPS4594  Sunday, June 4   
Genitourinary
Carcinoma                                     8:00-11:30 a.m.    
(Nonprostate)
(JAVELIN Renal
101)

Avelumab plus
axitinib vs
sunitinib as
first-line
treatment of                                                    
advanced renal                             
cell carcinoma:
phase 3 study
(JAVELIN Renal
101)

Urothelial              Apolo AB        4528   Sunday, June 4    
Genitourinary
Carcinoma                                     8:00-11:30 a.m.  
(Nonprostate) Cancer
(JAVELIN Solid
Tumor)

Updated efficacy
and safety of                                                   
avelumab in
metastatic
urothelial
carcinoma: pooled                          
analysis from 2
cohorts of the
phase 1b JAVELIN
Solid Tumor study

Publications

Merkel Cell            Bharmal M      e21070
Carcinoma
(JAVELIN Merkel
200)

Non-progression
during avelumab
treatment is
associated with
clinically
relevant
improvements in
health-related
quality of life
in patients with
Merkel cell
carcinoma          

Merkel Cell           Kaufman HL      e21065
Carcinoma
(JAVELIN Merkel
200)

Patient
experiences with
avelumab vs
chemotherapy for
treating Merkel
cell carcinoma:
results from
protocol-specified
qualitative
research          

Non-Small Cell            Feng Z      e20581
Lung Cancer
(JAVELIN Solid
Tumor)

Comparative study
of two PD-L1
expression assays
in patients with
non-small cell
lung cancer
(NSCLC)              

*Avelumab is under clinical investigation for treatment of NSCLC, RCC, DLBCL, SSCHN and mCRPC and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for NSCLC, RCC, DLBCL, SSCHN and mCRPC by any health authority worldwide.

About Avelumab

Avelumab is a human antibody specific for a protein called PD-L1, or programmed death

ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. 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 has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Indications

The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is not approved for any indication in any market outside the US.

Important Safety Information

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

About the Merck-Pfizer Alliance

Immuno-oncology is a top priority for Merck and Pfizer Inc. 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 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 in combination regimens, and is striving to find new ways to treat cancer.

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Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

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Pfizer Disclosure Notice

The information contained in this release is as of May 17, 2017. 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 BAVENCIO (avelumab), the Merck-Pfizer 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, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; 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 potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for BAVENCIO for metastatic Merkel cell carcinoma in the EU) 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 BAVENCIO, 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, 2016, 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 http://www.sec.gov and http://www.pfizer.com.

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