AstraZeneca (AZ) has shared positive results from a late-stage trial of its Imfinzi (durvalumab)-based perioperative regimen in gastric cancer.
The phase 3 MATTERHORN study has been evaluating Imfinzi in combination with standard-of-care fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy prior to surgery, followed by Imfinzi plus chemotherapy after surgery, then Imfinzi monotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.
The Imfinzi-based regimen demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) compared to perioperative chemotherapy alone.
A strong trend in favour of the Imfinzi regimen was also observed for the secondary endpoint of overall survival, which will be formally assessed at the final analysis, and the safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, with no new safety findings found.
Gastric cancer is the fifth leading cause of cancer-related deaths globally, with almost one million cases of the disease diagnosed globally every year.
Despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy, approximately one in four patients with resectable gastric cancer develop recurrent disease within one year, and one in four do not survive beyond two years.
AZ’s Imfinzi is an immunotherapy that targets the PD-L1 protein, which cancer cells use to evade the immune system. The drug already holds approvals in lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma.
Cristian Massacesi, chief medical officer and oncology chief development officer at AZ, said: “MATTERHORN is the first phase 3 trial of an immunotherapy to show a statistically significant improvement in EFS 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.”
Data from the trial will now be presented at a forthcoming medical meeting and shared with global regulatory authorities, AZ outlined.
The results come less than a month after AZ shared positive phase 3 results for an Imfinzi perioperative regimen in muscle-invasive bladder cancer at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium.