Yufan Liu, Jeannette Nashed, Amy Barone, Mengdie Yuan, Anup Amatya, Yue Xiang, Hong Zhao, Youwei Bi, Melissa A. Pegues, Claudia P. Miller, Ashley Lane, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, R. Angelo de Claro, Erin Larkins
On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (hereafter referred to as tarlatamab) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval was based on data from DeLLphi-301 (NCT05060016), an open-label, multicenter, multicohort trial involving patients with relapsed/refractory SCLC with disease progression after platinum-based chemotherapy and at least one other line of systemic therapy. Among 99 patients, the overall response rate (ORR) was 40% [95% confidence interval (CI), 31%-51%], with a median duration of response (DoR) of 9.7 months (range, 2.7-20.7+ months). The most common adverse reactions (≥20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea. Product labeling includes a Boxed Warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).