Four-Year Outcomes for Nivolumab With Chemotherapy and Bevacizumab in Patients With Nonsquamous NSCLC in the TASUKI-52.

Phase III TASUKI-52: 4-year outcomes

Population & design

• • Untreated advanced nonsquamous NSCLC.
• • Randomized 1:1 to:
  • • Nivolumab + carboplatin/paclitaxel + bevacizumab (n=275)
  • • Placebo + carboplatin/paclitaxel + bevacizumab (n=275)
• • Minimum follow-up: 53.1 months.
• • Endpoints: overall survival (OS), progression-free survival (PFS), duration of response (DOR), safety, and characteristics of 4-year survivors.

Efficacy

• • OS:
  • • Hazard ratio (HR) 0.71 (95% CI 0.58–0.88), favoring nivolumab.
  • • 4-year OS: 34.7% vs 22.1% (nivolumab vs control).
• • PFS:
  • • HR 0.61 (95% CI 0.50–0.74), favoring nivolumab.
  • • 4-year PFS: 13.7% vs 3.3%.
• • DOR among 4-year survivors:
  • • Median 34.7 months (nivolumab) vs 13.5 months (control), numerically longer with nivolumab.

Safety

• • No new safety signals with longer follow-up.
• • Toxicity remained consistent with known profiles of the regimen.

Prognostic factors among 4-year survivors

• • Favorable: age <65 and absence of bone metastases.
• • Not clearly associated: PD-L1 status and tumor size.

Clinical implication

• • Adding nivolumab to carboplatin/paclitaxel plus bevacizumab provides durable PFS and OS benefit with manageable safety, supporting this regimen as a first-line option for advanced nonsquamous NSCLC.