The U.S. Food and Drug Administration has accepted Bristol-Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a treatment for resected high-risk advanced melanoma.
The agency also granted the application priority review status, which accelerates FDA review time from 10 months to six months.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, meaning it is an immunotherapy designed to harness the body’s own immune system and restore its anti-tumor response.
Because of this immune-centered mechanism of action, Opdivo is becoming an important treatment option across multiple oncology indications. Opdivo is now approved for seven cancer indications, including six solid cancers and classical Hodgkin’s lymphoma (see full list of indications here).
The FDA had previously granted Opdivo breakthrough therapy status for this new indication as a way to expedite its development and review, making this the seventh indication for which Opdivo has received this designation.
“Priority review of our sBLA and the granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence,” Murdo Gordon, executive vice president and chief commercial officer of Bristol-Myers Squibb, said in a press release.
The sBLA is based on results from the CheckMate -238 Phase 3 trial (NCT02388906), evaluating whether Opdivo can outperform Yervoy (ipilimumab) in the prevention of recurrent melanoma after surgery. Yervoy is another BMS immune checkpoint inhibitor that is FDA-approved for the treatment of Stage 3 melanoma following surgery.
The study’s primary endpoint was time to the first recurrence or death, also called recurrence-free survival. Secondary endpoints included overall survival, recurrence-free survival by PD-L1 tumor expression, safety, and quality of life.
At 12 months, 70.5% of patients in the Opdivo group were alive and recurrence-free, compared to 60.8% in the Yervoy arm. This represented a 35% reduction in the risk of disease progression, with the trial meeting its primary endpoint.
Also, treatment-related adverse events were lower in the Opdivo arm (14.4%) compared to the Yervoy group (45.9%), highlighting the superior safety of the treatment.
Results of the CheckMate -238 trial were recently published in the New England Journal of Medicine in the study titled “Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.”
They were also presented during the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, on the same day. The presentation was titled “Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate 238).”
Melanoma has five stages of severity, from 0 to 4, based on thickness, ulceration of the tumor, or if the cancer has spread to the lymph nodes and beyond.
In Stage 3 melanoma, the cancer has reached the regional lymph nodes but has not yet reached the adjuvant lymph nodes, or other body parts. In this case, the patient might need surgical removal of the primary tumor as well as of the affected lymph nodes.
After this treatment the cancer still has a significant chance of returning, so some patients also receive adjuvant therapy (additional treatments to lower the risk of cancer recurrence) after surgery. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, or immunotherapy, among others.
