BMS eyes approval for second Opdivo combo in kidney cancer

Bristol Myers Squibb has reported positive data for a combination of its PD-L1 inhibitor Opdivo with Exelixis’ Cabometyx in renal cell carcinoma (RCC), where it already has approval alongside CTLA-4 inhibitor Yervoy.

The results, presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress, detailed a 40% reduction in the risk of death among previously untreated RCC patients receiving Opdivo (nivolumab) plus tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) compared to Pfizer’s older drug Sutent (sunitinib). According to BMS, the benefit applied to all patients regardless of their PD-L1 status.

The combo also met the primary trial endpoint of achieving a statically significant improvement in progression-free survival (PFS), with Opdivo plus Cabometyx hitting a median PFS of 16.6 months compared to 8.3 months for Sutent.

The Opdivo/Cabometyx combination also demonstrated a superior objective response rate when compared to Sutent, with almost twice as many patients responding to BMS’ treatment compared to Pfizer's – 56% and 27%, respectively.

Opdivo is already approved in combination with Yervoy (ipilimumab) as an initial treatment for advanced RCC patients, after the treatment showed an ability to improve survival compared to Sutent.

However, it has been facing competition from Merck & Co/MSD’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) plus Pfizer’s TKI Inlyta (ipilimumab) after the combination treatment won US Food and Drug Administration (FDA) approval in the same indication last year.

Topline results from the phase 3 Keynote-426 trial of Keytruda plus Inlyta in first-line RCC showed an overall response rate of 59.3%, alongside a 47% reduction in the risk of death compared to Sutent.

Although Keytruda plus Inlyta outperformed BMS’ combos in RCC, Opdivo has the advantage of being the first immunotherapy to win approval in this cancer type and has strong – and lasting – efficacy data in this market.

“This data is yet another example of the potential of immunotherapy-based combinations to meaningfully extend survival for patients with advanced cancers, strengthening our legacy in the genitourinary space,” said Nick Botwood, vice president, interim head, Oncology Development at Bristol Myers Squibb.

“Opdivo was the first immune checkpoint inhibitor approved as a second-line treatment for advanced renal cell carcinoma and then, with the addition of Yervoy, the first dual immunotherapy approved for certain patients in the first-line setting,” he added.

BMS and Exelixis have already completed their respective FDA submissions for Opdivo plus Cabometyx in RCC, with BMS adding that it also plans to discuss the data with other regulatory authorities across the world.

This includes in the EU, where the European Medicines Agency (EMA) recently validated the completion of BMS/Exelixis’ submissions and the beginning of the agency’s centralised review process of the combination treatment.