Merck KGaA and Pfizer Submit sBLA for Bavencio as First-Line Maintenance Therapy in Locally Advanced or Metastatic Urothelial Carcinoma, Granted FDA Breakthrough Therapy Designation

On the 10th, Merck KGaA and Pfizer jointly announced that they had submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for their co-developed PD-L1 antibody Bavencio (avelumab) as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma (UC). Meanwhile, the FDA granted this therapy Breakthrough Therapy designation and decided to review it using the Real-Time Oncology Review (RTOR) pilot program.

Urothelial carcinoma is the most common type of bladder cancer, accounting for 90% of all cases. According to statistics cited in a press release, more than 500,000 new cases of bladder cancer were diagnosed globally in 2018, and approximately 200,000 patients died from the disease worldwide. Cisplatin-based chemotherapy is typically recommended as the first-line treatment; for patients who are ineligible for this regimen due to health reasons, carboplatin-based chemotherapy serves as the next alternative. However, fewer than half of patients respond to carboplatin-based regimens, and their prognosis is poorer compared to those receiving cisplatin-based therapy.

Bavencio is a fully humanized PD-L1 monoclonal antibody co-developed by Merck KGaA and Pfizer. By binding to PD-L1, it prevents cancer cells from using PD-L1 to evade the anti-tumor immune response, thereby activating T cells to participate in tumor killing. Bavencio has received FDA approval for the treatment of metastatic Merkel cell carcinoma (MCC) and for patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously undergone chemotherapy.

Image source: Reference [2]

This submission is based on the positive results obtained from the Phase 3 clinical trial JAVELIN Bladder 100. This trial was a randomized, multicenter clinical study involving 700 patients with locally advanced or metastatic urothelial carcinoma (UC) who had received induction chemotherapy and whose disease had not progressed. Patients were randomly assigned to receive either first-line maintenance therapy consisting of Bavencio plus best supportive care (BSC), or BSC alone. The trial results demonstrated that, compared with the BSC group, the Bavencio combination therapy significantly prolonged overall survival (OS) in UC patients, thereby meeting the primary endpoint of the study. Detailed data from this trial will be presented at future medical conferences.

“Bavencio is the first immunotherapy to demonstrate a significant improvement in overall survival for patients with locally advanced or metastatic urothelial carcinoma in a Phase 3 clinical trial,” said Dr. Chris Boshoff, Chief Development Officer, Oncology, Global Product Development at Pfizer. “We are pleased that Bavencio has received Breakthrough Therapy Designation and will be reviewed through the Real-Time Oncology Review pilot program, which will accelerate patient access to this therapy.”

References:

[1] EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO^® for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma. Retrieved 2020-04-09, from https://www.prnewswire.com/news-releases/emd-serono-and-pfizer-receive-us-fda-breakthrough-therapy-designation-and-submit-application-for-bavencio-for-first-line-maintenance-treatment-of-locally-advanced-or-metastatic-urothelial-carcinoma-301037913.html

[2] Pfizer, Merck KGaA's Bavencio posts first-in-class bladder cancer win. Retrieved 2020-04-09, from https://www.fiercepharma.com/pharma/pfizer-merck-kgaa-s-bavencio-posts-first-class-bladder-cancer-win

Original Title: Express | First-Line Maintenance Therapy Improves Overall Survival in Bladder Cancer Patients, PD-L1 Inhibitor Receives Breakthrough Therapy Designation

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