FDA Approves Tremelimumab in Combination With Additional Medication for Metastatic Non-Small Cell Lung Cancer
The FDA has approved tremelimumab—a monoclonal antibody—in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC).
The treatment’s approval follows the completion of a randomized, multicenter, active-controlled, open-label study that evaluated patients with NSCLC who did not receive systematic treatment prior to the newly approved treatment.
Participants in the study were randomly divided into three treatment arms:
- Tremelimumab, durvalumab, and platinum-based chemotherapy for four cycles, followed by durvalumab and maintenance chemotherapy every 4 weeks. At week 16, patients were treated with a fifth dose of tremelimumab.
- Durvalumab with platinum-based chemotherapy for four cycles followed by durvalumab and maintenance chemotherapy.
- Platinum-based chemotherapy for six cycles followed by maintenance chemotherapy.
The researchers compared treatment arms one and three to determine their approval of treatment. In total, both cohorts included 675 patients. Upon their analysis, the researchers found that tremelimumab combined with durvalumab and platinum-based chemotherapy demonstrated a strong overall survival rate compared with only platinum-based chemotherapy treatment. The overall response rate of treatment arm one was 39% (95% CI, 34 to 44) compared with the response rate of treatment arm three (24% [95% CI, 20 to 29]).
Common adverse reactions, which occurred in over 20% of patients, included nausea, fatigue, decreased appetite, musculoskeletal pain, rash, and diarrhea.
FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. US Food and Drug Administration; November 18, 2022. Accessed December 7, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non