FDA Approves Cabozantinib Plus Nivolumab for Frontline Advanced RCC

“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib — progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

The approval is based off findings from the phase 3 CheckMate-9ER trial, which analyzed cabozantinib plus nivolumab compared to sunitinib in patients with previously untreated advanced or metastatic RCC. Results, which were published at the European Society of Medical Oncology Virtual Congress, showed that the combination improved overall survival and compared to the sunitinib arm.

CheckMate-9ER findings also showed that the cabozantinib/nivolumab arm doubled average progression-free survival (PFS) over the sunitinib arm, at 16.6 months and 8.3 months, respectively. Objective response rate was also doubled in the cabozantinib/nivolumab arm, 56% versus 27% respectively.

“While significant progress has been made in the treatment landscape for advanced kidney cancer over the last several years, patients still need more therapeutic options to treat this disease as we search for a possible cure,” said Bryan Lewis, President and Co-founder of KidneyCAN.

“As patients are living longer with advanced kidney cancer, focusing on the safety and effectiveness of new treatments has become even more important. The findings for the combination of Cabometyx and Opdivo in the CheckMate -9ER trial make the FDA approval of this combination a notable development for the patient community,” Lewis said.

Adverse events (AEs) with were consistent with what was previously seen with cabozantinib (a TKI inhibitor) and nivolumab (an immunotherapy agent). Common AEs that occurred in 20% or more of patients included: diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection

The FDA recommends the following dosage: 240 mg every 2 weeks of nivolumab via IV infusion or 480 mg every 4 weeks and 40 mg of cabozantinib orally every day without food until disease progression or unacceptable toxicity.

“With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer,” Choueiri said.