Dr. Halmos on the FDA Approval of Tremelimumab Plus Durvalumab and Chemotherapy in NSCLC

Balazs Halmos, MD, professor, medical oncology, Department of Oncology, professor, oncology and hematology, Department of medicine, chief, thoracic oncology, Albert Einstein College of Medicine, Montefiore Medical Center, discusses the significance of the FDA approval of tremelimumab-actl (Imjudo) plus durvalumab (Imfinzi) and chemotherapy in patients with metastatic non–small cell lung cancer (NSCLC).

On November 10, 2022, the FDA granted approval to the combination of tremelimumab, durvalumab, and platinum-based chemotherapy for adult patients with metastatic NSCLC without sensitizing ALK or EGFR aberrations. The regulatory decision was based on the results of the phase 3 POSEIDON trial (NCT03164616), in which the combination elicited an overall survival (OS) of 14 months vs 11.7 months with chemotherapy alone.

This decision marks the first approval for tremelimumab for any indication in NSCLC, Halmos says. The POSEIDON trial compared tremelimumab plus durvalumab and doublet chemotherapy vs durvalumab plus chemotherapy vs chemotherapy alone, and showed that the 4-drug combination elicited significant progression-free survival and OS benefits, Halmos explains.

Integrating this combination into clinical practice will be a challenge, as many other regimens are already approved, such as the phase 3 CheckMate 227 (NCT02477826) regimen of nivolumab (Opdivo) plus ipilimumab (Yervoy) and the phase 3 CheckMate 9LA (NCT03215706) regimen of nivolumab plus ipilimumab plus chemotherapy, Halmos emphasizes. However, this newly approved combination could bring additional value to certain cohorts of patients, such as those with poor prognostic factors, although further research is needed to determine exactly who will benefit most, Halmos concludes.