Merck KGaA and Pfizer’s combo impresses in first-line treatment of advanced kidney cancer
pharmafile | September 12, 2018 | News story | Research and Development, Sales and Marketing | Cancer, Kidney cancer, Merck KGaA, Pfizer, pharma
Bavencio (avelumab), Merck KGaA and Pfizer’s human anti-programmed death ligand-1 (PD-L1) antibody, combined with the latter’s Inlyta (axitinib) has shown strong results in a Phase 3 trial investigating its efficacy as a first-line therapy for patients with advanced renal cell carcinoma (RCC) compared to Pfizer’s Sutent (sunitinib).
In the JAVELIN Renal 101 study, the combination was found to produce “statistically significant improvement in progression-free survival (PFS)” in tumours with a PD-L1+ expression greater than 1% and regardless of PD-L1 expression – findings that were confirmed by an Independent Data Monitoring Committee.
The study is currently ongoing to determine how effectively the combo fares in improving overall survival, but the firms have said they now plan to file the drug in the US based on these new data.
“We are encouraged by these data which illustrate the impact of Bavencio in combination with Inlyta as a potential first-line treatment for people with advanced RCC, a serious and life-threatening cancer,” said Dr Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA. “They also support our firm belief in the promise of combining Bavencio with currently approved therapies and novel agents, a strong focus of the overall JAVELIN clinical development programme.”
Dr Chris Boshoff, Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, at Pfizer Global Product Development, also remarked: “JAVELIN Renal 101 is the first positive Phase III study combining an immune checkpoint blocker with a TKI, supporting the potential of Bavencio and Inlyta as a new cancer treatment approach for patients with advanced RCC. These positive results reinforce Pfizer’s long-standing heritage in advancing standards of care for people with RCC, and we look forward to discussing these data in greater detail with health authorities.”
Matt Fellows
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