- Year: 2023
- Title: LIBRETTO-431
- Subtitle: First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC
- Trial Type: A Multicenter, Randomized, Open-Label, Phase 3 Trial
Objective: To determine if the study drug selpercatinib, compared to a standard treatment, is effective and safe in participants with RET fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
Inclusion Criteria:
- At least 18 years of age
- Having unresectable, stage IIIB, IIIC, or IV, non-squamous, RET fusion-positive NSCLC
- Participants who had not previously received systemic treatment for metastatic disease
- Adequate hematologic, hepatic, and renal function
Participants: 212 Patients
Treatment Groups:
- Selpercatinib (160 mg twice daily) – 129 patients
- Control group (Chemotherapy and/or Pembrolizumab) – 83 patients
Primary Outcome:
- Median progression-free survival (Months)
- Intention-to-treat-pembrolizumab population: HR, 0.46; 95% CI, 0.31-0.70 (P<0.001)
Secondary Outcomes:
- The percentage of patients with an objective response %: Selpercatinib 84, Control group 65
- Median response duration (Months): Selpercatinib 24.2, Control group 11.5
Conclusion: Treatment with selpercatinib led to significantly longer progression-free survival than platinum-based chemotherapy with or without pembrolizumab among patients with advanced RET fusion-positive NSCLC.
Reference: Zhou C et al. N Engl J Med 2023; 389:1839-1850