LIBRETTO-431 Trial: Selpercatinib in NSCLC

libretto 431 trial
  • 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

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