Tarlatamab received accelerated approval for treatment of patients with previously treated small-cell lung cancer. It meaningfully improved overall survival compared with Chemotherapy in SCLC patients that progressed on or after initial platinum-based CTx. These observations are from the results of Phase 3 DeLLphi-304 clinical trial, published by investigators in Journal of Clinical Oncology and presnted at 2025 American Society of Clinical Oncology Annual Meeting in Chicago.
In phase 1 and 2 trials, tarlatamab demonstrated promising efficacy amomg SCLC patients. It was granted approval by FDA in 2024 for patients with extensive-Stage SCLC. In this latest study, findings showed that a median followup of 11.2 months for patients treated with tarlatamab and 11.7 months for those with chemotherapy treatment. Tarlatamab led to a median OS of 13.6 months in comparison to 8.3 months for chemotherapy.
In this DeLLphi trial, 509 patients with SCLC were enrolled who had disease progression after first-line platinum-based chemotherapy, with or withouorPD-(L)1 inhibitor. The patients were randomly assigned to receive tarlatamab or chemotherapy. Chemotherapy included topotecan, lurbinectedin or amrubicin. Tarlatamab improved the objective respinse rate, duration of response, PFS and OS. The results from this trial were published in The New England Journal of Medicine as well.
study author Charles Rudin said, “Taking the efficacy and safety data together, I think these data clearly support tarlatamab as a preferable therapy for patients in the second-line setting for small-cell lung cancer. Beyond redefining the standard of care for these patients, this study also establishes a new paradigm for the use of bispecific T-cell engager immunotherapies in our patients with lung cancer.”
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