FDA Approves Merck/Pfizer PD-L1 Inhibitor Bavencio as First-Line Maintenance Therapy for Urothelial Carcinoma

From: Jike Pharmaceutical News

Today, Merck KGaA and Pfizer jointly announced that the U.S. FDA has approved the supplemental Biologics License Application (sBLA) for the PD-L1 antibody Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have not progressed following platinum-containing chemotherapy.The press release noted that this is the first first-line immunotherapy to demonstrate a significant improvement in overall survival for this patient population in Phase 3 clinical trials.

Bladder cancer is the 10th most common cancer worldwide. In 2018, more than 500,000 new cases of bladder cancer were diagnosed globally, and approximately 200,000 people died from the disease. Urothelial carcinoma (UC) accounts for about 90% of all bladder cancers. It becomes more difficult to treat as the disease progresses by spreading through the layers of the bladder wall. Based on higher initial response rates, platinum-based chemotherapy is currently the standard first-line treatment for eligible patients with advanced disease. However, most patients eventually experience disease progression within 9 months after initiating treatment, and only 5% of patients diagnosed with metastatic disease survive beyond 5 years.

Bavencio is a humanized anti-PD-L1 monoclonal antibody. Bavencio has been shown to stimulate both adaptive and innate immune functions in preclinical models. By blocking the interaction between PD-L1 and the PD-1 receptor, Bavencio has been demonstrated to relieve the suppression of T cell-mediated anti-tumor immune responses in preclinical models. In November 2014, Merck KGaA and Pfizer announced a strategic alliance to jointly develop and commercialize Bavencio.

This approval is based on the results of the Phase 3 JAVELIN Bladder 100 trial, which demonstrated that Bavencio as first-line maintenance therapy in combination with best supportive care (BSC) significantly improved median overall survival (OS) by 7.1 months compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9). The risk of death in the overall population was reduced by 31% (HR=0.69; 95% CI: 0.56-0.86; P=0.001).

Dr. Petros Grivas, one of the principal investigators of the JAVELIN Bladder 100 trial, stated, “As the first immunotherapy to statistically demonstrate a significant improvement in overall survival in the first-line treatment of locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab represents one of the most notable advances in the treatment paradigm for this condition in 30 years. The JAVELIN Bladder 100 regimen, utilizing avelumab as first-line switch maintenance therapy, has the potential to become a new standard of care.”

References: [1] FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Retrieved 2020-07-01, from https://www.prnewswire.com/news-releases/fda-approves-bavencio-as-first-line-maintenance-treatment-for-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-301086396.html

Original Title: FDA Approves German Merck/Pfizer PD-L1 Inhibitor for First-Line Maintenance Treatment of Patients with Urothelial Carcinoma

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