Opdivo Approved for Renal Cell Carcinoma, Melanoma

Opdivo found to improve overall survival compared with other leading cancer therapies.

The FDA issued a pair of approvals yesterday and today for nivolumab (Opdivo) in the treatment of 2 different cancers.

On Monday, Opdivo was approved for metastatic renal cell carcinoma (RCC) following prior anti-angiogenic therapy, while an approval was granted today for Opdivo as a single agent treatment of BRAF V600 wild-type (WT) unresectable or metastatic melanoma.

“Our focused approach to Immuno-Oncology research is to deliver treatment options that have the potential to improve long-term survival outcomes for patients,” said Michael Giordano, MD, senior vice president and head of Oncology Development at Bristol-Myers Squibb. “Opdivo has become a critical part of the treatment landscape for advanced melanoma patients and their physicians, both as a monotherapy and in combination, and we are committed to exploring opportunities for this treatment across stages of disease and lines of therapy.”

The approval in RCC followed a phase 3 trial that showed Opdivo reduced the risk of death by 27% compared with everolimus (Afinitor), which is an overall 5.4-month improvement in median overall survival (OS).

The results of the study showed that after a minimum follow-up of 14 months, median OS was 25 months with Opdivo compared with 19.6 months with Afinitor (HR, 0.73; 98.5% CI, 0.57-0.93; P = .002).

Median progression free survival was 4.6 months with Opdivo versus 4.4 months with Afinitor (HR, 0.88; 95% CI, 0.75-1.03; P = .11). In patients who did not progress at 6 months, median PFS was 15.6 months with Opdivo compared with 11.7 months with Afinitor.

The approval of Opdivo for the treatment of melanoma followed CheckMate -066, a randomized, double-blind phase 3 trial of treatment-naïve patients with unresectable or metastatic BRAF WT melanoma. Patients received Opdivo or dacarbazine chemotherapy with a primary efficacy endpoint of OS and secondary endpoints for progression-free survival (PFS) and objective response rate (ORR).

Opdivo was found to offer superior OS compared with chemotherapy. Median OS was not reached for the Opdivo group, compared with 10.8 months in the dacarbazine group. Median PFS was 5.1 months with Opdivo compared with 2.2 months with dacarbazine.

ORR with Opdivo was 34% (4% complete response rate, 30% partial response rate [95% CI: 28-41]) compared with 9% in the dacarbazine (1% complete response rate, 8% partial response rate [95% CI: 5-13]) treatment arm.

Immune-mediated adverse events associated with Opdivo include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis; infusion reactions; and embryofetal toxicity.

“Advanced melanoma continues to be one of the deadliest and most challenging cancers to treat, and ongoing research in Immuno-Oncology from clinical trials like CheckMate -066 shows the potential to provide improved overall survival for newly diagnosed patients with BRAF wild-type metastatic melanoma,” said Jeffrey S. Weber, MD, PhD, deputy director of the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. “This important news means that we now have another new option to offer patients with BRAF wild-type metastatic melanoma.”