AZN : Imfinzi Improves Event-Free Survival In Early-Stage Gastric & GEJ Cancers In Phase III Trial

AstraZeneca

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(RTTNews) - The Imfinzi-based regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers, according to AstraZeneca Plc.'s (AZN.L, AZN) MATTERHORN Phase III trial results.

The company noted that 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.

Positive results from the Phase III trial showed perioperative treatment with AstraZeneca's Imfinzi (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS).

Patients were treated with neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

For the secondary endpoint of overall survival (OS), a strong trend was observed in favour of the Imfinzi-based regimen at this interim analysis. The trial will continue to follow overall survival, which will be formally assessed at the final analysis, the company said.

The company noted that the safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, and there were no new safety findings.

In a previously reported interim analysis for the key secondary endpoint of pathologic complete response (pCR), the Imfinzi combination more than doubled the pathologic complete response rate compared to neoadjuvant chemotherapy alone.

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