(Gastric Cancer) Nivolumab Plus Chemotherapy: Is It Effective?
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- January 26, 2022
- Reading time: 2 minutes
On January 11, 2022, Yoon-Koo Kang and colleagues at the University of Ulsan College of Medicine published in the medical journal The Lancet the efficacy and safety results of the ATTRACTION-4 Phase 2/3 trial evaluating first-line treatment with the anti-PD-1 antibody nivolumab plus chemotherapy in patients with HER2-negative unresectable or recurrent gastric cancer and gastroesophageal junction (GEJ) cancer.
ATTRACTION-4 Phase 2/3 Trial Design
ATTRACTION-4 was a multicenter, double-blind trial. Patients with HER2-negative unresectable or recurrent gastric cancer and GEJ cancer (N=724) were randomized 1:1 to:
- Nivolumab group: 360 mg nivolumab + chemotherapy on Day 1 of each 3-week cycle (N=362)
- Placebo group: Placebo + chemotherapy (N=362)
The primary endpoint was progression-free survival (PFS).
Efficacy Results
At a median follow-up of 11.6 months, median PFS was:
- Nivolumab group: 10.45 months / Placebo group: 8.34 months
- The nivolumab group showed a 32% reduction in the risk of disease progression or death
At a median follow-up of 26.6 months, median overall survival (OS) was:
- Nivolumab group: 17.45 months / Placebo group: 17.15 months
- The nivolumab group showed a 10% reduction in the risk of death for OS
Safety Profile
Grade 3–4 adverse events most commonly confirmed in patients were:
- Neutropenia: Nivolumab 20% (N=71/359) / Placebo 16% (N=57/358)
- Thrombocytopenia: Nivolumab 9% (N=34) / Placebo 9% (N=33)
- Serious adverse events: Nivolumab 25% (N=88) / Placebo 14% (N=51)
- Most common: decreased appetite (Nivolumab 5% [N=18] / Placebo 3% [N=10])
Conclusions
Based on the ATTRACTION-4 results, Yoon-Koo Kang and colleagues concluded that first-line nivolumab plus chemotherapy significantly improved PFS in HER2-negative unresectable or recurrent gastric cancer and GEJ cancer patients. Although the improvement in OS was more modest, this combination is expected to become a promising new first-line treatment option.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00692-6/fulltext
- Immunotherapy
- Clinical trial drug
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