PAP opening to nivolumab + ipilimumab
After the recent opening of two Early Access Programs (PAP) to tepotinib and amivantamab (see news here!) for the treatment of two subtypes of lung cancer, INFARMED granted the request for a PAP to nivolumab in combination with ipilimumab for the treatment of unresectable malignant pleural mesothelioma.
This approval is based on the results of CheckMate 743, a multicenter, open-label, randomized (1:1) study, in which patients were divided into two treatment arms: nivolumab (3 mg/kg intravenously once every 2 weeks) plus ipilimumab (1 mg/kg intravenously once every 6 weeks) for up to 2 years, or platinum chemotherapy plus pemetrexed (pemetrexed [500 mg/m2 intravenous] plus cisplatin [75 mg/m2 intravenously] or carboplatin once every 3 weeks for up to six cycles.
The primary endpoint was overall survival among all participants randomly assigned to treatment, and safety was assessed in all participants who received at least one dose of study treatment.
Data from a pre-specified interim analysis, based on a minimum follow-up of 22 months, showed that nivolumab + ipilimumab combination therapy resulted in a 4-month improvement in median overall survival compared to platinum-based dual chemotherapy (18 .1 versus 14.1 months; HR = 0.74, 95% CI 0.60-0.91; p = 0.0020). The 2-year overall survival rates were 40.8% in the immunotherapy arm versus 27.0% in the chemotherapy arm.
In summary, nivolumab + ipilimumab provided significant and clinically significant improvements in overall survival versusstandard chemotherapy, which is very important, given that pleural mesothelioma is a rare and aggressive type of cancer, resistant to several treatments, causing patients to have a poor prognosis.
The relevance of the approval of this PAP by INFARMED is thus evident, with the following therapeutic indication: “Nivolumab in combination with ipilimumab, in the first-line treatment of adult patients with unresectable malignant pleural mesothelioma, ineligible for chemotherapy according to the criteria clear and objective.”