Long-Term Follow-Up Supports Treatment with Opdivo in Advanced Renal Cell Carcinoma

After five years of follow-up, treatment with Opdivo in those with previously treated advanced or metastatic renal cell carcinoma induced superior survival outcomes.

At five years of follow-up, treatment with Opdivo (nivolumab) demonstrated superior overall survival and objective response rates, compared with Afinitor (everolimus), in patients with previously treated advanced or metastatic renal cell carcinoma (RCC), according to results from the phase 3 Checkmate-025 study.

“Five-year survival results from the CheckMate-025 study, along with the ongoing response rates observed in the trial, highlight the potential for long-term survival and efficacy of nivolumab monotherapy for patients with previously-treated advanced RCC,” said lead investigator Dr. Robert J. Motzer, the Kidney Cancer Section Head at Memorial Sloan Kettering Cancer Center in New York City, in a press release.

Renal cell carcinoma is the most common type of kidney cancer in adults, which is approximately twice as common in men than women. Globally, the five-year survival rates for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.

“These data represent the longest follow-up for a PD-1 immune checkpoint inhibitor in this setting and underscore the potential increased survival rates nivolumab can deliver for patients with advanced RCC who have received prior antiangiogenic therapy,” he added.

In the open-label, randomized Checkmate-025 trial, which was presented on at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium, held in San Francisco from Feb. 13-15, the researchers compared the efficacy and safety of Opdivo with Afinitor in 803 patients with previously treated advanced renal cell carcinoma (RCC) after prior anti-angiogenic therapy.

In total, 406 patients received 3 mg/kg of Opdivo intravenously every two weeks and 397 patients were given 10 mg of oral Afinitor once daily, until disease progression or unacceptable toxicity.

Overall survival served as the primary endpoint of the study, while secondary endpoints included objective response rate, progression-free survival (the time from treatment to disease progression or worsening), quality of life and safety.

With an extended minimum follow-up of 64 months, the Opdivo arm demonstrated superior overall survival (26% versus 18%), compared with Afinitor. In addition, 23% of patients treated with Opdivo experienced a response, compared with 4% of those given Afinitor. The median duration of response for Opdivo was also maintained longer than for Afinitor (18.2 months versus 14 months, respectively).

The incidence and type of treatment-related side effects were consistent with those seen in the primary analysis of the study. Overall, 21% of patients in the Opdivo arm and 37% in the Afinitor arm experienced grade 3-4 side effects.

“The updated CheckMate-025 results support why Opdivo monotherapy became a standard of care for previously treated RCC patients worldwide and offer additional evidence that treatment with Opdivo has the potential to help patients live longer,” Brian Lamon, development lead of genitourinary cancers at Bristol-Myers Squibb, said in the press release. “This study represents exciting progress in our mission to improve survival outcomes for all patients.”