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AstraZeneca has reported positive “high-level” outcomes from the randomised Phase III MATTERHORN trial of Imfinzi (durvalumab) with standard-of-care fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy in individuals with resectable, early-stage, and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
In the double-blind, placebo-controlled, multi-centre trial, the perioperative treatment with Imfinzi plus FLOT showed “improvement” in event-free survival (EFS), the primary endpoint.
Subjects in the trial received a neoadjuvant combination of Imfinzi and chemotherapy before surgery, with adjuvant Imfinzi with chemotherapy followed, and then Imfinzi as a single agent.
They were enrolled across 176 centres in 20 nations, including Asia, Canada, Europe, South America, and the US.
AstraZeneca Oncology chief development officer and chief medical officer Cristian Massacesi said: “MATTERHORN is the first Phase III trial of an immunotherapy to show a statistically significant improvement in event-free survival in patients with resectable gastric and gastroesophageal junction cancers.
“This perioperative approach with Imfinzi underscores our commitment to moving into earlier stages of cancer where novel therapies can have the biggest impact on patients’ lives.”
AstraZeneca noted that 948 subjects were randomised and given a 1500mg fixed dosage of this human monoclonal antibody and FLOT chemotherapy or placebo with the chemo every four weeks for two cycles before surgery.
Imfinzi or placebo every four weeks followed for up to 12 cycles post-surgery.
According to the company, at the interim analysis, a “strong” trend towards overall survival (OS) was observed favouring the Imfinzi-based regimen, although this secondary endpoint will be formally evaluated at the trial's final analysis.
Imfinzi plus FLOT chemotherapy’s safety profile aligned with the established profiles of every medicine, presenting no new safety findings.
Gastric cancer is stated to be the fifth leading cause of cancer mortality worldwide.
The company recently reported positive outcomes from a planned interim analysis of Phase III SERENA-6 trial of camizestrant and a cyclin-dependent kinase (CDK) 4/6 inhibitor as first-line treatment of people with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.
"AstraZeneca reports positive outcomes from trial of Imfinzi" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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