MATTERHORN (gastric cancer)
Trial question
What is the effect of perioperative durvalumab in patients with resectable gastric or GEJ adenocarcinoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 948
948 patients (266 female, 682 male).
Inclusion criteria: adult patients with resectable gastric or GEJ adenocarcinoma.
Key exclusion criteria: peritoneal dissemination or distant metastasis; squamous cell or adenosquamous cell carcinoma; gastrointestinal stromal tumor; current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab; contraindication to any of the study drugs; history of allogeneic organ transplantation.
Interventions
N=474 perioperative durvalumab plus chemotherapy (durvalumab 1,500 mg every 4 weeks plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for 4 cycles).
N=474 perioperative chemotherapy alone (matching placebo every 4 weeks plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for 4 cycles).
Primary outcome
Event-free survival at 2 years
67.4%
58.5%
67.4 %
50.6 %
33.7 %
16.9 %
0.0 %
Perioperative durvalumab plus
chemotherapy
Perioperative chemotherapy
alone
Significant
increase ▲
NNT = 11
Significant increase in event-free survival at 2 years (67.4% vs. 58.5%; HR 1.41, 95% CI 1.16 to 1.72).
Secondary outcomes
Significant increase in overall survival at 2 years (75.7% vs. 70.4%; AD 5.3%, 95% CI 0.51 to 10.09).
Significant increase in pathological complete response (19.2% vs. 7.2%; RR 2.69, 95% CI 1.86 to 3.9).
Significant increase in disease-free survival at 2 years (75.2% vs. 66.2%; HR 1.43, 95% CI 1.08 to 1.89).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with resectable gastric or GEJ adenocarcinoma, perioperative durvalumab plus chemotherapy was superior to perioperative chemotherapy alone with respect to a event-free survival at 2 years.
Reference
Yelena Y Janjigian, Salah-Eddin Al-Batran, Zev A Wainberg et al. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jun 1. Online ahead of print.
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