Business Wire

Merck and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer

Del

Not intended for UK-based media

Merck and Pfizer today announced the initiation of an international Phase III study of the investigational cancer immunotherapy avelumab* in a treatment naïve advanced NSCLC setting. The study, JAVELIN Lung 100, is designed to assess the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer. Avelumab (previously known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer.

The Phase III study is an open-label, multicenter, randomized clinical trial in which patients with recurrent or Stage IV PD-L1+ NSCLC will receive either avelumab or the investigator’s choice of platinum-based chemotherapy, depending on the patient’s histology (either squamous or non-squamous), as first-line treatment. Patients will be pre-screened for PD-L1+ status using an immunohistochemistry-based companion diagnostic test.

The study expects to enroll approximately 420 patients across more than 240 sites in Africa, America (North and South), Asia and Europe. Clinical trials in North America on behalf of Merck will be conducted by EMD Serono, the company’s US and Canadian biopharma business.

“Through this Phase III trial, we hope to gain a better understanding of avelumab as a potential first-line treatment for non-small cell lung cancer – a prevalent and devastating disease,” said Dr. Luciano Rossetti, Head of Global Research & Development at Merck’s biopharma business. “We are working to help patients with this challenging cancer and will continue to develop our NSCLC program by evaluating avelumab as a potential monotherapy and in combination with our extensive portfolios of approved and investigational oncology therapies.”

The primary endpoint of the study is progression-free survival in patients with PD-L1+ tumors. Secondary endpoints include progression-free survival in patients with strongly PD-L1 positive (PD-L1++) tumors, overall survival, objective response rate, quality of life, tolerability and safety in patients treated with avelumab versus investigator-choice chemotherapy. This is the second randomized Phase III study of avelumab in NSCLC initiated in just over six months; the first study was initiated in April 2015 and is evaluating avelumab in patients whose disease has progressed after receiving a platinum-containing doublet chemotherapy compared with docetaxel.

“There is great promise for the use of immunotherapy in the treatment of non-small cell lung cancer and this new trial underscores our continuing commitment to investigating potential immune-based treatment options for this devastating disease,” said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. “The clinical development program for avelumab continues to accelerate, and the initiation of this Phase III study represents another important achievement in 2015 for the alliance between Merck and Pfizer.”

The clinical development program for avelumab now includes more than 1,400 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal (GEJ) cancers, head and neck cancer, Merkel cell carcinoma, melanoma, NSCLC, ovarian cancer, renal cell carcinoma and urothelial (e.g., bladder) cancer.

*Avelumab is the proposed International Non-proprietary 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.

References

  1. American Cancer Society (2015) Global Facts & Figures Third Edition. Available from: www.cancer.org/acs/groups/content/@research/documents/document/acspc-044738.pdf. Accessed October 2015.
  2. American Cancer Society (2015) Lung Cancer (Non-Small Cell) [Fact sheet]. Available from: www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf. Accessed October 2015.
  3. Mayo Clinic (2015) Cancer survival rate: what it means for your prognosis: http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/cancer/art-20044517. Accessed October 2015.

About Non-Small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women,1 responsible for more deaths than colon, breast and prostate cancer combined2. NSCLC is the most common type of lung cancer, accounting for 85 to 90 percent of all lung cancers2. The five-year survival rate for people diagnosed with late-stage lung cancer that has spread (metastasized) to other areas of the body is 4 percent.3

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 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 will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.

Pfizer Inc.: Working together for a healthier world ®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of € 11.3 billion in 66 countries.

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. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Pfizer Disclosure Notice

The information contained in this release is as of November 4, 2015. 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), including a potential indication for avelumab for the treatment of patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer, 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, including the risk that the final results of the Phase I study for avelumab and/or additional clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development; 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, 2014, 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 SEC and available at www.sec.gov and www.pfizer.com.

Contact information

Merck
Media: Gangolf Schrimpf, +49 6151 72 9591
Investor Relations: +49 6151 72 3321
or
Pfizer
Media: Sally Beatty, +1 212 733 6566
Investor Relations: Ryan Crowe, +1 212 733 8160

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00Pressemelding

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08Pressemelding

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15Pressemelding

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47Pressemelding

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom