Skip to main content

Imjudo FDA Approved with Imfinzi and Chemotherapy for Metastatic NSCLC

January 2023, Vol 13, No 1

Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations.

The efficacy of this immunotherapy combination plus chemotherapy was evaluated in the phase 3 POSEIDON clinical trial, a randomized, multicenter, open-label study of patients with metastatic NSCLC who had not received systemic treatment. Patients were randomized to 1 of 3 treatment arms: (1) tremelimumab, durvalumab, and platinum-based chemotherapy for 4 cycles, followed by durvalumab and maintenance chemotherapy every 4 weeks, and a fifth dose of tremelimumab at week 16; (2) durvalumab plus platinum-based chemotherapy for 4 cycles, followed by durvalumab and maintenance chemotherapy; or (3) platinum-based chemotherapy for 6 cycles, followed by maintenance chemotherapy. Treatment was continued until disease progression or unacceptable adverse events.

The FDA approval was based on the results of the 675 patients in arms 1 and 3. The main efficacy measures included progression-free survival (PFS) and overall survival (OS). Tremelimumab plus durvalumab and chemotherapy showed a significant and clinically meaningful improvement in OS versus chemotherapy alone (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65-0.92; 2-sided P = .00304).

The median OS was 14 months (95% CI, 11.7-16.1) with the triplet combination versus 11.7 months (95% CI, 10.5-13.1) with chemotherapy alone. The median PFS was 6.2 months (95% CI, 5.0-6.5) and 4.8 months (95% CI, 4.6-5.8), respectively (HR, 0.72; 2-sided P = .00031). The overall response rate was 39% versus 4%, respectively, and the median duration of response was 9.5 months versus 5.1 months, respectively.

The most common (≥20%) adverse events with the triplet were nausea, fatigue, decreased appetite, musculoskeletal pain, rash, and diarrhea. Grade 3 or 4 laboratory abnormalities (≥10%) were neutropenia, anemia, leukopenia, lymphocytopenia, increased lipase, hyponatremia, and thrombocytopenia.

Related Articles