Gastric/GEJ cancer: 3rd-line nivolumab boosts OS

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Takeaway

  • Nivolumab offers improved OS compared with placebo as a third-line therapy for patients with advanced gastric or gastroesophageal junction (GEJ) cancer who are refractory or intolerant to ≥2 lines of chemotherapy.

Why this matters

  • Current guidelines offer no guidance on third-line therapy for patients in whom prior chemotherapy regimens have failed to treat advanced gastric or gastroesophageal junction cancer.

Study design

  • Randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ATTRACTION-2).
  • 493 patients with advanced or recurrent gastric or gastroesophageal junction cancer previously treated with ≥2 chemotherapy regimens received nivolumab (n=330) or placebo (n=163).
  • Funding: Ono Pharmaceutical and Bristol-Myers Squibb.

Key results

  • Significantly longer median OS in nivolumab group vs placebo (5.26 mo vs 4.14 mo).
  • 68.5% of nivolumab and 86.5% of placebo patients died (HR, 0.63; P<.0001).
  • Risk for disease progression lower in the nivolumab group vs placebo (HR, 0.60; 95% CI, 0.49-0.75), with median PFS 1.61 mo with nivolumab and 1.45 mo with placebo.
  • 10% of nivolumab group reported grade 3-4 adverse events (AEs) vs 4% in placebo; 5 patients in nivolumab and 2 in placebo group died from treatment-related AEs.

Limitations

  • No data on QoL.