MATTERHORN
Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer
Phase 3N = 948NCT04592913
- Population
- Adults with previously untreated, histologically documented resectable gastric or gastro-oesophageal junction adenocarcinoma, eligible for radical surgery (stage II-IVa).
- Design
- Multinational, double-blind, randomised phase 3 trial (147 medical centres in 20 countries per the 2026 report): durvalumab 1500 mg or placebo every 4 weeks plus FLOT for four cycles (two neoadjuvant, two adjuvant), then durvalumab or placebo every 4 weeks for ten further cycles. Stratified by region, clinical node status and PD-L1 expression. 948 randomised (474 per arm) of 1258 enrolled. The ClinicalTrials.gov record lists 957 participants, which differs from the 948 randomised in the papers.
- Primary endpoint
- EFS
- Arms
- Placebo plus FLOT (control, n = 474): Placebo with FLOT, then placebo
- Durvalumab plus FLOT (experimental, n = 474): Durvalumab 1500 mg with FLOT, then durvalumab
- People
- Janjigian YY, senior author MATTERHORN Investigators
EFSHR 0.71 (95% CI 0.58–0.86)Δ 24-month EFS+8.9 pointsΔ pCR+12 pointsΔ 24-month OS+5.3 pointsOSHR 0.78 (95% CI 0.63–0.96)
Show the numbers
| Endpoint | Analysis | Durvalumab plus FLOT | Placebo plus FLOT | Effect |
|---|---|---|---|---|
| EFSAll randomised participants (474 per arm) | primarymedian follow-up 31.5 monthsJanjigian 2025 | 67.4% at 2 y | 58.5% at 2 y | HR 0.71 (95% CI 0.58–0.86)P<0.001 |
| pCRAll randomised participants (474 per arm) | primaryJanjigian 2025 | 19.2% | 7.2% | A secondary endpoint in the 2025 report. Relative risk 2.69 (95% CI 1.86 to 3.90) as published. |
| OSAll randomised participants (474 per arm) | interimJanjigian 2025 | 75.7% at 2 y | 70.4% at 2 y | P=0.03Overall survival was a secondary endpoint. Piecewise hazard ratios as published: 0.99 (95% CI 0.70 to 1.39) for months 0 to 12 and 0.67 (0.50 to 0.90) from month 12 onward. The reported P value of 0.03 did not cross the prespecified significance threshold of P<0.0001. |
| OS | finalJanjigian 2026 | — | — | HR 0.78 (95% CI 0.63–0.96)P=0.021Key secondary endpoint, final analysis; prespecified significance threshold p<0.0499. Medians and landmark rates are not given in the abstract. |
| Endpoint | Analysis | Durvalumab plus FLOT | Placebo plus FLOT | Effect |
|---|---|---|---|---|
| EFSAll randomised participants (474 per arm) | primarymedian follow-up 31.5 monthsJanjigian 2025 | 67.4% at 2 y | 58.5% at 2 y | HR 0.71 (95% CI 0.58–0.86)P<0.001 |
| pCRAll randomised participants (474 per arm) | primaryJanjigian 2025 | 19.2% | 7.2% | A secondary endpoint in the 2025 report. Relative risk 2.69 (95% CI 1.86 to 3.90) as published. |
| OSAll randomised participants (474 per arm) | interimJanjigian 2025 | 75.7% at 2 y | 70.4% at 2 y | P=0.03Overall survival was a secondary endpoint. Piecewise hazard ratios as published: 0.99 (95% CI 0.70 to 1.39) for months 0 to 12 and 0.67 (0.50 to 0.90) from month 12 onward. The reported P value of 0.03 did not cross the prespecified significance threshold of P<0.0001. |
| OS | finalJanjigian 2026 | — | — | HR 0.78 (95% CI 0.63–0.96)P=0.021Key secondary endpoint, final analysis; prespecified significance threshold p<0.0499. Medians and landmark rates are not given in the abstract. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| EFS | 0.71 | 0.58–0.86 |
| OS | 0.78 | 0.63–0.96 |
Appears in
Sources
Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, et al. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025;393(3):217-230.
Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, et al. Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet. 2026;408(10560):1114-1128.