Article Type
Changed
Tue, 04/15/2025 - 10:21

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 04/15/2025 - 10:20
Un-Gate On Date
Tue, 04/15/2025 - 10:20
Use ProPublica
CFC Schedule Remove Status
Tue, 04/15/2025 - 10:20
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Tue, 04/15/2025 - 10:20