2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.72 (Poster) Trial in Progress: Randomized Phase 3 Study of Tarlatamab, a DLL3-Targeting BiTE® (Bispecific T-cell Engager) Immunotherapy, Compared to Standard of Care in Patients With Relapsed Small Cell Lung Cancer (DeLLphi-304)

PP01.72 (Poster) Trial in Progress: Randomized Phase 3 Study of Tarlatamab, a DLL3-Targeting BiTE® (Bispecific T-cell Engager) Immunotherapy, Compared to Standard of Care in Patients With Relapsed Small Cell Lung Cancer (DeLLphi-304)

Back to course

Pdf Summary

The IASLC 2023 North America Conference on Lung Cancer presented data on tarlatamab, a bispecific T-cell engager (BiTE) molecule targeting delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC). DLL3 is expressed on SCLC cells and rarely on normal tissues, making it an attractive target. Tarlatamab binds to DLL3 on SCLC cells and CD3 on T cells, leading to T-cell mediated tumor lysis.<br /><br />The DeLLphi-304 study is a phase 3 trial comparing the efficacy and safety of tarlatamab with standard of care (SOC) in patients with relapsed SCLC after first-line platinum-based chemotherapy. Preliminary phase 1 and 2 studies showed promising results, with a manageable safety profile and encouraging antitumor activity.<br /><br />In the phase 2 dose evaluation/expansion study, the 10 mg dose of tarlatamab showed an objective response rate (ORR) of 40%, including one complete and 39 partial responses. The median time to response was 1.4 months, and the median duration of response was not reached. The disease control rate (DCR) was 70%. The median progression-free survival (PFS) was 4.9 months, and the median overall survival (OS) was 14.3 months. Tarlatamab had a favorable benefit to risk profile, with a low rate of discontinuations due to treatment-related adverse events.<br /><br />The ongoing phase 3 DeLLphi-304 trial aims to further evaluate the efficacy and safety of tarlatamab compared to SOC in relapsed SCLC. The primary endpoint is overall survival, and key secondary endpoints include progression-free survival and patient-reported outcomes. The study is enrolling approximately 700 patients at 200 sites globally.<br /><br />Overall, tarlatamab shows promising results as a potential treatment option for patients with relapsed SCLC. Ongoing clinical trials will provide more information on its long-term response durability and survival benefits.

Asset Subtitle

Hossein Borghaei

Keywords

tarlatamab

bispecific T-cell engager

DLL3

small cell lung cancer

relapsed SCLC

progression-free survival

overall survival

DeLLphi-304 trial

patient-reported outcomes

clinical trials