Biotechnology company Amgen Inc (NASDAQ: AMGN) announced on Monday that it presented new data for its first-in-class bispecific T-cell engager, IMDELLTRA (Tarlatamab-dlle), targeting DLL3 in extensive-stage small cell lung cancer (ES-SCLC) during the World Conference on Lung Cancer (WCLC) 2024. Results from the Phase 1b DeLLphi-303 study demonstrated that IMDELLTRA, in combination with PD-L1 inhibitors, serves as an effective first-line maintenance therapy.

Findings highlighted manageable safety and positive survival outcomes from the combination therapy. In the IMDELLTRA and Durvalumab arm, the disease control rate was 62.5%, with a 9-month overall survival of 91.8% and a median progression-free survival of 5.3 months. In the IMDELLTRA and Atezolizumab cohort, a similar disease control rate of 62.5% was noted, with a median duration of disease control at 7.2 months and a 9-month overall survival of 86.7%.

Long-term follow-up data from the DeLLphi-301 Phase 2 study reaffirmed the drug's sustained efficacy and safety in previously treated ES-SCLC patients. The objective response rate was 40% among 100 patients, with a median overall survival of 15.2 months.

Safety profiles indicated treatment-related adverse events, with Durvalumab resulting in 15% dose interruptions and Atezolizumab at 17%. Cytokine Release Syndrome primarily manifested as grade 1-2, while Immune effector cell-associated neurotoxicity syndrome occurred infrequently.

IMDELLTRA, which targets DLL3 on cancer cells and CD3 on T cells, received accelerated FDA approval on 16 May 2024 for patients experiencing disease progression after platinum-based chemotherapy. Ongoing studies will further clarify its efficacy and safety profile in treating this challenging malignancy.