AstraZeneca's Imfinzi has the potential to 'redefine care for patients with gastrointestinal cancers' interim analysis shows

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags gastroesophageal junction cancers Cancer Clinical trials Patient centricity Oncology

A new treatment approach to improve outcomes for patients with earlier stages of gastric and gastroesophageal junction cancers has had positive high-level results from a planned interim analysis of a phase 3 trial.

The interim analysis of the Matterhorn trial showed treatment with AstraZenca’s Imfinzi (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel neoadjuvant, pre-surgery chemotherapy demonstrated a statistically significant and clinically meaningful improvement.

This was in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone for patients with resectable, early-stage and locally advanced stages (2, 3, 4a) gastric and gastroesophageal junction (GEJ) cancers.

Josep Tabernero is head of the medical oncology department, Vall d'Hebron University Hospital, Barcelona, Spain, and principal investigator of the trial.

He 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.”

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

Susan Galbraith, executive vice president, oncology research and development at AstraZeneca, said: “These early results from Matterhorn support harnessing the immune system together with chemotherapy and surgery as a new treatment approach to improve outcomes for patients with earlier stages of gastric and gastroesophageal junction cancers.

“These findings reinforce our focus on delivering novel Imfinzi-based treatments that have the potential to redefine care for patients with gastrointestinal cancers.”

The team found in their research that gastric cancer is the fourth leading cause of cancer death globally, with more than one million people diagnosed each year. ​By 2030, approximately 70,000 patients in the US, EU and Japan will be newly diagnosed with stage 2-3 gastric or GEJ cancers.

Approximately one in four patients with gastric cancer who undergo surgery with curative intent develop recurrent disease within one year, reflecting a high unmet medical need. 

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