Bavencio extends survival at Phase 3 in previously untreated locally advanced or metastatic urothelial carcinoma

pharmafile | January 7, 2020 | News story | Manufacturing and Production, Research and Development Bavencio, Merck KGaA, Pfizer, pharma 

Bavencio (avelumab), the anti-programmed death ligand-1 (PD-L1) antibody co-developed by Pfizer and Merck KGaA’s biopharma unit EMD Serono, has been shown to extend survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC).

The Phase 3 data revealed that the therapy, in combination with best supportive care (BSC), demonstrated a “statistically significant improvement” in overall survival compared to BSC alone, meeting the study’s primary endpoint.

The data related specifically to patients whose disease did not progress on induction chemotherapy and who were randomised to receive first-line maintenance therapy.

“Our unique maintenance approach with Bavencio has significantly prolonged survival for patients with locally advanced or metastatic urothelial carcinoma in this trial,” said Luciano Rossetti, Head of Global R&D at EMD Serono. “We believe this approach could become part of routine clinical practice, as these results are a major advance on the existing standard of care.”

Dr Chris Boshoff, Chief Development Officer, Oncology at Pfizer Global Product Development, added: “Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma. These latest positive data from the JAVELIN clinical development programme add to the body of evidence for Bavencio in the treatment of genitourinary cancers, and we look forward to discussing these results with health authorities.”

The pair of companies confirmed that the full raft of data will be presented at an upcoming event, with plans to also submit them to the FDA and other global regulatory bodies.

Matt Fellows

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