The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) submitted by Bristol-Myers Squibb seeking approval for Opdivo (nivolumab) to treat patients with hepatocellular carcinoma (HCC) who received prior Nexavar (sorafenib) therapy.
The FDA granted the application priority review, which reduces the review time from 10 months to six months. The action date is Sept. 24, 2017.
“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC, which is often diagnosed in the advanced stage when treatment options are limited,” Dr. Ian M. Waxman, development lead for gastrointestinal cancers at Bristol-Myers Squibb, said in a press release. “We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting.”
The submission was based on data from the Phase 1/2 CheckMate-040 (NCT01658878), which is assessing the safety and efficacy of Opdivo in advanced HCC patients, with or without hepatitis B virus or hepatitis C virus infection.
Results from the trial, to be presented at the upcoming American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, in Chicago, have shown that Opdivo induces durable responses with long-term survival and favorable safety in both patients who never received Nexavar, and in those who did. Responses occurred regardless of PD-L1 expression.
The open-label, non-comparative, dose escalation and expansion trial took place at 46 hospitals or academic centers in the United States, Canada, Europe and Asia. It main outcome measures were safety and tolerability and overall response rate. Secondary endpoints included duration of response, disease control rate and overall survival.
Opdivo showed a manageable safety profile and acceptable tolerability. Among the 214 patients treated with Opdivo 3 mg/kg in the dose expansion part, 20 percent responded to treatment, with a median duration of response of 9.9 months, while 74 percent of patients were alive nine months after starting treatment.
Stratifying patients based on prior Nexavar treatment revealed that Nexavar-naive patients had a 23 percent overall response rate, compared to 16-19 percent for Nexavar-treated patients. In addition, those who had not taken Nexavar previously had a 12-month survival rate of 73 percent, compared to 58-60 percent for those who did.
The poster, “Nivolumab (nivo) in sorafenib (sor)-naive and -experienced pts with advanced hepatocellular carcinoma (HCC): CheckMate 040 study,” will be presented June 3.