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March 24, 2017

Merck KGaA, Pfizer PD-L1 mAb Wins Accelerated Approval for Rare Skin Cancer

  • The FDA approved Merck KGaA and Pfizer’s checkpoint inhibitor Bavencio® (avelumab) for treating metastatic Merkel cell carcinoma (mMCC) in adults and children aged 12 years and over. The fully human monoclonal antibody (mAb) is the first treatment approved for the rare, aggressive form of skin cancer, and was cleared through the agency’s accelerated approval process. Bavencio also has Breakthrough Therapy Designation.

    Pfizer and Merck KGaA inked their potentially $2.85 billion collaboration for global development of avelumab, and Pfizer’s programmed cell death protein 1 (PD-1) antibody, in 2014. Belén Garijo, M.D., CEO Healthcare and member of the executive board of Merck KGaA, commented, “Bavencio’s journey has included years of hard work—from the scientists who discovered this molecule in our labs, to our alliance with Pfizer and to the study participants and investigators worldwide.”

    “Today is a significant milestone for people fighting mMCC, who until now have not had any options beyond chemotherapy,” added Albert Bourla, Ph.D., group president, Pfizer Innovative Health. “This approval demonstrates the power of collaboration to accelerate meaningful new choices for cancer patients.”

    FDA cleared Bavencio based on data from the JAVELIN Merkel 200 study in 88 patients with mMCC that had progressed either during or after chemotherapy. The study demonstrated a 33% overall response rate, with 11 patients exhibiting a complete response, and 22% demonstrating a partial response. A total of 45% of responses lasted at least 12 months, and 86% lasted at least 6 months.

    In May 2016, FDA’s accelerated approval of Roche’s Tecentriq® (atezolizumab) in people with previously treated advanced bladder cancer marked the first clearance of a programmed death-ligand 1 (PD-L1) inhibitor for any indication. The drug has since been approved for treating metastatic non-small-cell lung cancer and in January was granted priority review for a second advanced bladder cancer indication.

    In contrast to inhibition of the PD-L1 ligand, Bristol-Myers Squibb’s (BMS) marketed checkpoint inhibitor Opdivo® (nivolumab) and Merck’s Keytruda® (pembrolizumab) target the PD-1 receptor. Just last month, BMS and Exelixis announced a clinical development collaboration to evaluate the latter’s small-molecule receptor tyrosine kinase inhibitor, combined with Opdivo, either alone or with Yervoy® (ipilimumab), for treating multiple tumor types.
     

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