IMFINZI® (durvalumab) plus chemotherapy significantly improved pathologic comple… – Press Release


First global Phase III trial of immunotherapy and chemotherapy combination to demonstrate clinical benefit in this setting

Trial will continue to assess event-free survival

Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI® (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) neoadjuvant (before surgery) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

The trial will continue as planned to assess event-free survival (EFS) and overall survival (OS) to which the trial team, investigators and participants remain blinded.

The safety and tolerability of adding IMFINZI to neoadjuvant FLOT chemotherapy was consistent with the known profile of this combination and did not decrease the number of patients able to undergo surgery versus chemotherapy alone.

Josep Tabernero, MD, PhD, head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain, and principal investigator of the MATTERHORN trial, said: “Patients with resectable gastric and gastroesophageal junction cancers urgently need better treatment options, because today, one in four patients still progress within one year even after surgery with curative intent. These results demonstrate an increase in pathologic complete response after adding durvalumab treatment to FLOT chemotherapy and surgery. This is an encouraging early sign that this regimen may deliver long-term clinical benefit for these patients, as pathologic complete response has been correlated with both event-free and overall survival in multiple settings.”

Susan Galbraith, Executive Vice…