Immunotherapy combination improves survival in advanced liver cancer
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The addition of nivolumab to ipilimumab significantly improved OS among adults with previously untreated advanced hepatocellular carcinoma, according to a release by the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 immune checkpoint inhibitor, whereas ipilimumab (Yervoy, Bristol Myers Squibb) is a CTLA-4-directed recombinant, human monoclonal antibody. The two agents, both alone and in combination, have received numerous indications for the treatment of malignancies.
FDA based approval on results from the randomized phase 3 CheckMate -9DW trial to evaluate the efficacy of nivolumab plus ipilimumab — compared with investigator’s choice of sorafenib or lenvatinib monotherapy — for the first-line treatment of adults with advanced hepatocellular carcinoma (HCC) that had not received prior systemic therapy.
Study investigators randomly assigned 668 patients to receive either 1 mg/kg of nivolumab plus 3 mg/kg ipilimumab for up to 4 doses followed by 480 mg nivolumab monotherapy or single-agent sorafenib or lenvatinib as oral capsules.
OS served as the study’s primary endpoint, with key secondary endpoints of objective response rate and time to symptom deterioration.
Combination of the two immunotherapy agents “demonstrated a statistically significant and clinically meaningful improvement in OS” compared with the study’s control arm.
Additionally, the safety profile of the combination treatment appeared consistent with previously reported data, with no new safety signals identified.
“[Patients with] advanced-stage liver cancer remain in need of additional treatment options that may help improve survival,” Dana Walker, MD, MSCE, vice president and global program lead of gastrointestinal and genitourinary cancers with Bristol Myers Squibb, said in the release. “The overall survival benefit demonstrated by the combination of Opdivo plus Yervoy in the CheckMate -9DW trial demonstrates its potential to improve outcomes compared to well-established TKI treatment options.”
Full results from the CheckMate -9DW trial will be shared at an upcoming medical conference, according to the manufacturer.
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