FDA approves Opdivo and Cabometyx combo for advanced kidney cancer treatment

The U.S. Food and Drug Administration (FDA) has officially approved the combination of Bristol Myers Squibb’s Opdivo (nivolumab) and Exelixis‘ Cabometyx (cabozantinib) for the first-line treatment of advanced renal cell carcinoma (RCC), a common and aggressive form of kidney cancer. This approval introduces a powerful new therapeutic option for patients, marking a significant milestone in the treatment of advanced kidney cancer.

What does the Opdivo and Cabometyx combination mean for advanced RCC patients?

The new FDA-approved combination regimen will see patients receive 240mg of Opdivo intravenously every two weeks or 480mg every four weeks, in combination with 40mg of Cabometyx tablets taken once daily. This treatment protocol follows a thorough review by the FDA, with the approval coming on the back of a priority review granted in October 2023. The approval also includes a notable contribution from the Real-Time Oncology Review (RTOR) pilot program, which aims to accelerate the availability of effective cancer therapies.

Opdivo, a PD-1 immune checkpoint inhibitor, has already been approved for use in various cancer types, either alone or in combination with other treatments. Cabometyx, a tyrosine kinase inhibitor, is an established therapy for advanced RCC and liver cancer. Together, these two therapies promise to offer patients a more robust and targeted approach to fighting advanced RCC.

The pivotal clinical trial results behind the approval

The FDA’s decision to approve the Opdivo-Cabometyx combination was based on the results of the CheckMate -9ER Phase 3 clinical trial. In this trial, 651 randomized patients with advanced RCC were treated with either the Opdivo-Cabometyx regimen or Pfizer’s sunitinib, a long-standing standard therapy for RCC. The results were compelling—patients treated with Opdivo and Cabometyx saw their survival rates double, while their tumors were less likely to progress compared to those on sunitinib. Additionally, the combination reduced the risk of death by 40% compared to sunitinib.

Expert opinions on the breakthrough approval

Michael M. Morrissey, President and CEO of Exelixis, expressed great enthusiasm for the approval, pointing out that this new combination not only demonstrated a significant improvement in survival rates but also delivered a remarkable improvement in progression-free survival and objective response rates compared to sunitinib. He noted that this approval represents a critical milestone for advanced RCC patients, reinforcing the growing potential of Cabometyx in combination with immune checkpoint inhibitors for treating other hard-to-treat cancers.

From Bristol Myers Squibb, Adam Lenkowsky, General Manager and Head of U.S. Oncology, Immunology, and Cardiovascular, highlighted that this approval expands Opdivo’s potential in RCC treatment, providing physicians with a new therapeutic option. According to Lenkowsky, the combination therapy could offer significant benefits for patients where immunotherapy plus a tyrosine kinase inhibitor regimen is deemed appropriate.

Impact on the future of kidney cancer treatment

With the FDA’s approval of this combination therapy, patients with advanced renal cell carcinoma now have access to a treatment regimen that significantly improves survival outcomes and reduces tumor progression. The approval signals a new era of hope for those affected by advanced RCC, providing a much-needed alternative to traditional therapies and offering a promising path toward more effective cancer care.

As the treatment landscape for advanced RCC evolves, it is clear that the combination of Opdivo and Cabometyx represents a breakthrough in the fight against kidney cancer, potentially transforming how this aggressive disease is managed moving forward.