Nivolumab Plus Cabozantinib Demonstrates Positive Results for Renal Cell Carcinoma

The combination of nivolumab (Opdivo) plus cabozantinib (Cabometyx) demonstrated sustained response rate and survival benefits compared with sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC), according to 3-year follow-up data from the phase 2 CheckMate -9ER trial.

Additionally, a biomarker analysis showed improvements in median progression-free survival (PFS) and overall survival (OS) were sustained with the combination, regardless of the individual’s programmed death-ligand 1 status.

“Despite the progress made through science and medicine, there remains a need for treatment options that can durably extend survival for patients with metastatic [RCC], especially for those classified as higher risk,” Mauricio Burotto, MD, medical director at Bradford Hill Clinical Research Center in Santiago, Chile, said in a statement.

“With these updated results from CheckMate -9ER, we’ve now seen nivolumab in combination with cabozantinib durably extend survival and sustain response benefits compared to sunitinib for over 3 years, regardless of patients’ risk classification. These results reinforce the importance of this immunotherapy-tyrosine kinase inhibitor regimen for patients and its potential to help change survival expectations for patients with this challenging cancer,” Burotto said.

Investigators found that treatment with the combination continued to show a 30% reduction in the risk of death, as well as an improvement of median OS at 49.5 months for the combination and 35.5 for sunitinib. Further, the median OS improved by 11.8 months since the previous data cut at the 32.9 months median follow-up.

PFS benefits were also sustained, continuing to double at 16.6 months compared with 8.4 months, respectively. Duration of response (DoR) and objective response rate (ORR) benefits were also maintained.

Investigators reported that nearly twice as many individuals responded to the combination with sunitinib at 55.7% compared with 28.4%, respectively, for ORR. The median DoR was 23.1 months compared with 15.2 months, respectively.

Complete response (CR) rates were also sustained, with 12.4% of individuals treated with the combination having CR compared with just 5.2% on sunitinib.

Furthermore, approximately 97% of individuals treated with the combination experienced a treatment-related adverse event (TRAE) of any grade compared with approximately 93% of individuals with sunitinib. Approximately 67% and 55% had a grade 3 or greater TRAEs, respectively.

The updated results were featured in 1 oral and 1 poster presentation at the American Society of Clinical Oncology 2023 Genitourinary Cancers Symposium (ASCO GU) between February 16 and 18, 2023.

“With 44 months median follow-up, the compelling survival benefit further reinforces the value of the cabozantinib and nivolumab combination regimen as a first-line option for patients with advanced kidney cancer,” Vicki Goodman, MD, chief medical officer and executive vice president of product development and medical Affairs at Exelixis, which markets Cabometyx, said in the statement. “We are pleased to share these long-term findings at ASCO GU and remain steadfast in our longstanding commitment to improving outcomes for patients living with advanced kidney cancer.”

Reference

Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) shows durable survival with over three years of follow-up in the CheckMate -9ER trial in first-line advanced renal cell carcinoma. Bristol Myer Squibb. News release. February 14, 2023. Accessed February 22, 2023. https://news.bms.com/news/details/2023/Opdivo-nivolumab-in-Combination-with-CABOMETYX-cabozantinib-Shows-Durable-Survival-with-Over-Three-Years-of-Follow-Up-in-the-CheckMate--9ER-Trial-in-First-Line-Advanced-Renal-Cell-Carcinoma/default.aspx