FDA approves tremelimumab regimen for metastatic non-small cell lung cancer
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The FDA approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for certain patients with metastatic non-small cell lung cancer.
The indication applies to adults with metastatic NSCLC who do not have sensitizing EGFR mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Tremelimumab (Imjudo, AstraZeneca) is an anti-CTLA-4 monoclonal antibody. Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
Earlier this fall, the FDA approved the combination for adults with unresectable hepatocellular carcinoma.
The agency based the new indication on results of the randomized phase 3 POSEIDON trial, which included patients with NSCLC with no sensitizing EGFR mutations or ALK aberrations. Study participants had not received prior systemic treatment.
Researchers randomly assigned study participants to one of three treatment arms.
In one group, patients received tremelimumab, durvalumab and platinum-based chemotherapy for four cycles, followed by durvalumab and maintenance chemotherapy every 4 weeks, followed by a fifth tremelimumab dose at week 16.
In the second group, patients received durvalumab plus platinum-based chemotherapy for four cycles followed by durvalumab and maintenance chemotherapy.
In the third group, patients received platinum-based chemotherapy for six cycles followed by maintenance chemotherapy.
PFS and OS served as the major efficacy outcome measures.
Researchers reported a statistically significant improvement in OS with tremelimumab, durvalumab and chemotherapy compared with chemotherapy alone (median, 14 months vs. 11.7 months; HR = 0.77; 95% CI, 0.65-0.92). Researchers also observed improved PFS (median, 6.2 months vs. 4.8 months) and a higher overall response rate (39% vs. 24%) with tremelimumab, durvalumab and chemotherapy.
Adverse reactions that occurred among at least 20% of patients assigned tremelimumab, durvalumab and chemotherapy included nausea, fatigue, decreased appetite, musculoskeletal pain, rash and diarrhea. Grade 3 or grade 4 laboratory abnormalities that occurred among at least 10% of patients included neutropenia, anemia, leukopenia, lymphocytopenia, lipase increase, hyponatremia and thrombocytopenia.
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