- Part A was conducted in 88 patients with histologically confirmed mMCC whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with life expectancy of more than 3 months, and a minimum follow-up of 18 months. Overall in Part A, 59% of patients were reported to have had one prior anti-cancer therapy for mMCC and 41% had two or more prior therapies. The major efficacy outcome measures for Part A were confirmed best overall response (BOR) and DOR, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by a blinded independent endpoint review committee (IERC). - Part B, at the time of the data cut-off, included 39 patients with histologically confirmed mMCC who were treatment-naive to systemic therapy, 29 of whom had at least 13 weeks of follow-up. Enrollment in Part B of the study is ongoing and is planned to include 112 treatment-naive patients. For Part B, the major efficacy outcome measure is durable response, defined as objective response (CR or PR) with a duration of at least 6 months; secondary outcome measures include BOR, DOR, PFS and overall survival (OS).
The trial excluded patients with active or a history of central nervous system (CNS) metastasis, prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, active or a history of autoimmune disease, a history of other malignancies within the last 5 years, organ transplant, and conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C. Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
About BAVENCIO BAVENCIO(R) (avelumab) is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO 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. BAVENCIO 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 BAVENCIO.
| Indications in | the | US[12] | The | US | Food | and | Drug | Administration | (FDA) | granted | accelerated | approval | for | BAVENCIO for | the | treatment | of | (i) | 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. | These | indications | were | approved | under | accelerated | approval | based | on | tumor | response | rate | and | duration | of | response. | Continued | approval | for | these | indications | may | be | contingent | upon | verification | and | description | of | clinical | benefit | in | confirmatory | trials |
Important Safety Information from the US FDA Approved Label 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 BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
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 BAVENCIO, an investigational anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize BAVENCIO and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO, as a monotherapy, as well as combination regimens, and is striving to find new ways to treat cancer.
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About Merck Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 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 2016, Merck generated sales of EUR 15.0 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 except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Pfizer Inc.: Working together for a healthier world(R) 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. [http://www.pfizer.com ] In addition, to learn more, follow us on Twitter at @Pfizer [http://cts.businesswire.com/ct/CT?id=sma... ] and @Pfizer_News [http://cts.businesswire.com/ct/CT?id=sma... ] , LinkedIn [https://www.linkedin.com/company/pfizer ] and like us on Facebook at Facebook.com/Pfizer [http://cts.businesswire.com/ct/CT?id=sma... ] .
Pfizer Disclosure Notice The information contained in this release is as of September 21, 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.
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