Adults with unresectable or metastatic liver cancer now have access to the combination for first-line therapy.
US adults now have access to nivolumab with ipilimumab for the first-line treatment of unresectable hepatocellular carcinoma, thanks to new FDA approval.
The regulator announced the move on 11 April, citing efficacy and safety data from the CHECKMATE-9DW trial of almost 700 adults with unresectable or metastatic HCC.
The study found that patients taking the combination immunotherapy had increased overall survival and objective response rates compared with traditional therapy.
Patients with histologically confirmed cancer, Child Pugh Class A, ECOG performance status 0 or 1 and no prior systemic therapy for advanced disease were randomly assigned to receive the new treatment or the investigator’s choice of lenvatinib or sorafenib.
Those in the intervention group were given an IV infusion of nivolumab 1mg/kg with ipilimumab 3mg/kg IV every three weeks for a maximum of four doses, followed by nivolumab 480mg IV alone every four weeks
They found that overall survival was 23.7 months on average in the intervention group, compared with 20.6 months among people taking lenvatinib or sorafenib.
Objective response rates were 36.1% in the intervention group compared with 13.2% in the TYK inhibitor monotherapy group.
Rash, pruritus, fatigue and diarrhea were the most common reactions, reported in more than 20% of patients. They identified no new safety signals.
“The CheckMate-9DW approval is an important advancement for patients, considering the incidence of liver cancer has tripled in the last four decades, yet prognosis for HCC patients remains poor,” study author and US gastrointestinal medical oncologist Dr Aiwu Ruth He told press.
“The availability of a new first-line treatment option that demonstrated a deep response can offer adults with this form of liver cancer long-term overall survival and may help address an unmet need.
“Given the strength of evidence from the trial, especially considering the selection and performance of a strong comparator arm, I believe that Opdivo plus Yervoy has the potential to become a standard of care for the first-line treatment of patients with unresectable or metastatic HCC.”
In 2020, the immunotherapy combination was granted accelerated approval in the US, with this move confirming the indication to full approval and expanding it to allow for first-line treatment.
Clinicians were advised to monitor for immune-mediated adverse reactions, which could occur during or after treatment.
“Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with Opdivo and before each dose of Yervoy,” according to safety information from manufacturer Bristol Myers Squibb.
“In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative aetiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.”
Patients should be given systemic corticosteroids if treatment is paused or stopped until the disease improves to Grade 1 or less.
“Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy,” according to BMS.
