Amgen (AMGN) Presents New Tarlatamab Clinical Data At WCLC 2022

August 8, 2022 2:18 PM EDT

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Amgen (NASDAQ: AMGN) today announced new data from the DeLLphi300 clinical trial, a Phase 1 dose exploration and expansion study evaluating the safety and efficacy of investigational tarlatamab, a potential first-in-class half-life extended bispecific T-cell engager (HLE BiTE®) molecule targeting delta-like ligand 3 (DLL3), in small cell lung cancer (SCLC). Updated data from the ongoing Phase 1 study were presented at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) in Vienna, Austria.

"Small cell lung cancer is one of the most devastating and aggressive solid tumor cancers. The disease has lacked effective treatments with no therapies specifically approved to treat patients in the third-line setting," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Our Phase 1 data for tarlatamab presented earlier today at WCLC continues to demonstrate exciting antitumor activity with remarkable response durability in heavily pre-treated patients. We are encouraged by the overall survival of 13.2 months."

In heavily pretreated patients with SCLC (n=106), a population with few treatment options beyond first-line, investigational tarlatamab demonstrated encouraging antitumor activity with notable response durability. Tarlatamab delivered a confirmed ORR of 23% (confirmed and unconfirmed responses), a median duration of response of 13.0 months and a median overall survival (OS) of 13.2 months. Treatment-related adverse events (TRAEs) of any grade occurred in 97 patients (92%), and TRAEs grade ≥ 3 occurred in 33 patients (31%). Cytokine release syndrome (CRS) was primarily grade 1/2, mostly occurred in Cycle 1, rarely occurred in subsequent cycles and was generally manageable. Overall, treatment discontinuation due to treatment-related AEs was low (4%).

Based on these data, a potentially registrational Phase 2 study of tarlatamab in the third-line treatment of SCLC is currently enrolling patients. Additional studies investigating tarlatamab are underway, including DeLLphi-303, a Phase 1b study testing tarlatamab in combination with standard of care in first-line SCLC and a Phase 1b study in de novo or treatment-emergent neuroendocrine prostate cancer.

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