- 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.
- 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.
- 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.
- No data on QoL.