Amgen 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. 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.

Tarlatamab is an investigational potential first-in-class half-life extended bispecific T-cell engager (BiTE) molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in neuroendocrine cancers, such as small cell lung cancer (SCLC) and neuroendocrine prostate cancer – both of which have high unmet medical needs.1,2 DLL3 is highly upregulated on the cell surface of neuroendocrine tumors and rarely expressed on nonmalignant cells, making it a novel target for investigating a BiTE immuno-oncology molecule. Tarlatamab is being investigated in multiple studies, including DeLLphi-301, a potentially registrational Phase 2 study in relapsed/refractory SCLC; DeLLphi-303, a Phase 1b study testing tarlatamab in combination with standard of care therapies in first-line SCLC; DeLLphi-302, a Phase 1b combination study with AMG 404 in second-line or later SCLC; and DeLLpro-300, a Phase 1b study in de novo or treatment-emergent neuroendocrine prostate cancer. Small cell lung cancer (SCLC) is a particularly aggressive form of the disease that accounts for about 10% to 15% of all lung cancers.5 SCLC tends to spread faster than NSCLC, with nearly 70% of people with SCLC having metastatic disease at the time of diagnosis.

The five-year survival rate for advanced SCLC remains low at 3% and unfortunately treatment options have not changed much in several decades.6,7 Delta-like ligand 3 (DLL3) is an emerging treatment target that is expressed in greater than 80% of SCLC tumors with minimal expression in normal cells. BiTE® (bispecific T-cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens.

The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T-cell treatment available to all providers when their patients need it. Amgen is advancing a number of BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. At Amgen Oncology, our mission to serve patients drives all that we do.

That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer. For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.