Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Relapsed small cell lung cancer (SCLC) has a poor prognosis with current standard treatments like amrubicin (AMR).
• Preclinical data suggest anthracyclines may enhance anti-tumor immunity and synergize with immune checkpoint inhibitors.

Purpose of the Study:

• To evaluate the efficacy and safety of combining pembrolizumab with amrubicin in patients with relapsed SCLC.
• To determine the overall response rate (ORR) as the primary endpoint.

Main Methods:

• A clinical trial enrolled 25 patients with relapsed SCLC who had previously received platinum-based chemotherapy.
• Patients were treated with pembrolizumab plus amrubicin until disease progression.
• Key endpoints included ORR, progression-free survival (PFS), overall survival, and safety assessments.

Main Results:

• The combination therapy achieved an ORR of 52.0% (95% CI: 31.3%-72.2%).
• Median progression-free survival (PFS) was 4.0 months, with a 1-year PFS rate of 14.4%.
• Median overall survival was 10.6 months, with manageable toxicity including neutropenia and febrile neutropenia.

Conclusions:

• Pembrolizumab plus amrubicin demonstrated significant efficacy and tolerability in patients with relapsed SCLC.
• This combination represents a promising treatment option for this patient population.