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Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An

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Tarlatamab, a novel bispecific T-cell engager, shows promising results in treating small-cell lung cancer (SCLC). This therapy targeting Delta-like ligand 3 (DLL3) demonstrated manageable safety and durable responses in heavily pretreated patients.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Drug Development

Background:

  • Small-cell lung cancer (SCLC) is an aggressive cancer with limited therapeutic options.
  • Delta-like ligand 3 (DLL3) is a promising target due to its high expression in most SCLC cases.
  • Tarlatamab (AMG 757) is a bispecific T-cell engager designed to target both DLL3 and CD3.

Purpose of the Study:

  • To report Phase I results of tarlatamab in patients diagnosed with SCLC.
  • To evaluate the safety and efficacy of tarlatamab in patients with relapsed/refractory SCLC.

Main Methods:

  • A Phase I study involving dose exploration and expansion cohorts of tarlatamab in patients with SCLC.
  • Safety was assessed as the primary endpoint, with antitumor activity, overall survival, and pharmacokinetics as secondary endpoints.
  • Patients received varying doses of tarlatamab, with a focus on 100 mg in the expansion cohort.

Main Results:

  • Tarlatamab was administered to 107 patients, with 90.7% experiencing treatment-related adverse events, most commonly cytokine release syndrome.
  • The objective response rate was 23.4%, with a median duration of response of 12.3 months.
  • Median progression-free survival was 3.7 months, and median overall survival was 13.2 months, with exploratory analysis suggesting benefit in patients with higher DLL3 expression.

Conclusions:

  • Tarlatamab demonstrated manageable safety and encouraging response durability in heavily pretreated SCLC patients.
  • The study supports further investigation of tarlatamab as a potential treatment for SCLC.
  • Targeting DLL3 with tarlatamab shows clinical benefit, particularly in patients with elevated DLL3 expression.