Bavencio+Inlyta combo OK’d in Europe for first-line advanced kidney cancer

pharmafile | October 29, 2019 | News story | Manufacturing and Production, Sales and Marketing Bavencio, Cancer, Kidney cancer, Merck KGaA, Pfizer, inlyta, pharma 

Merck KGaA and Pfizer’s joint drug Bavencio (avelumab) has received European approval in combination with Inlyta (axitinib) in the first-line treatment of adult patients with advanced renal cell carcinoma (RCC), it has emerged.

The decision follows that of the FDA in the same indication, made earlier this year in May, and is based on findings that demonstrate that the combo “significantly lowered risk of disease progression or death” by 31% compared to Pfizer’s Sutent in advanced RCC patients regardless of PD-L1 status.

The combo was also shown to almost double objective response rate, recording a score of 52% versus 27.3% with Sutent. Research is ongoing to evaluate the combo’s overall survival benefit.

“There is a high incidence of kidney cancer in Europe, and for the most common type, renal cell carcinoma, we continue to need additional treatment options, particularly for patients with advanced disease, where outcomes are poorest,” commented Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor at the Institute of Cancer Research (ICR). “We’ve seen a demonstrated efficacy benefit and safety and tolerability profile for avelumab in combination with axitinib across all prognostic risk groups in patients with advanced renal cell carcinoma, so today’s approval in Europe brings an important option that can help healthcare professionals optimise treatment strategies across risk stratification.”

Rehan Verjee, Global Head of Innovative Medicine Franchises for Merck KGaA’s Biopharma business, also remarked: “This first European approval of an anti-PD-L1 as part of a combination treatment for advanced renal cell carcinoma builds on our commitment to bringing innovative treatment options to patients with hard-to-treat cancers through our extensive JAVELIN clinical trial programme. RCC is the most common form of kidney cancer, accounting for 90% of diagnoses. We are now working to make Bavencio in combination with axitinib available for patients with advanced renal cell carcinoma as quickly as possible.”

Matt Fellows

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