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AstraZeneca's 6-K Report: Imfinzi Shines in Phase III MATTERHORN Trial for Gastric Cancer

$AZN
Form 6-K
Filed on: 2025-03-07
Source
AstraZeneca's 6-K Report: Imfinzi Shines in Phase III MATTERHORN Trial for Gastric Cancer

Key Information and Insights from AstraZeneca's 6-K Filing on Imfinzi's Phase III MATTERHORN Trial

Company Overview:

  • Name: AstraZeneca PLC
  • Headquarters: Cambridge, United Kingdom
  • Industry Focus: Biopharmaceuticals, specifically Oncology and Gastrointestinal (GI) cancers.

Trial Overview:

  • Trial Name: MATTERHORN
  • Type: Randomized, double-blind, placebo-controlled, multi-center, global Phase III trial.
  • Participants: 948 patients with resectable Stage II-IVA gastric and gastroesophageal junction (GEJ) cancers.
  • Primary Endpoint: Event-Free Survival (EFS), defined as the time from randomization until disease progression or recurrence.

Results:

  • Improvement in EFS: The Imfinzi (durvalumab) regimen demonstrated a statistically significant and clinically meaningful improvement in EFS compared to standard chemotherapy alone.
  • Pathologic Complete Response Rate: The combination of Imfinzi with chemotherapy more than doubled the pathologic complete response rate (19% vs. 7%), with an odds ratio of 3.08 (p<0.00001).
  • Trend in Overall Survival: A strong trend in favor of the Imfinzi-based regimen was observed for the secondary endpoint of overall survival, which will be formally assessed in the final analysis.

Clinical Insights:

  • Gastric cancer represents the fifth leading cause of cancer death globally, with nearly one million new diagnoses annually.
  • The MATTERHORN trial is significant as it is the first to demonstrate superior EFS with an immunotherapy combination over the standard of care in early-stage gastric cancer.
  • Despite curative-intent therapy, recurrence remains common in gastric cancer, highlighting the need for innovative treatment options.

Expert Commentary:

  • Dr. Yelena Y. Janjigian: Principal investigator emphasized the positive implications of the trial results for improving patient outcomes and reducing recurrence risks.
  • Cristian Massacesi, CMO at AstraZeneca: Stressed the commitment to advancing treatments in earlier stages of cancer to maximize patient benefits.

Safety Profile:

  • The safety profile of the Imfinzi and FLOT chemotherapy combination was consistent with existing data, with no new safety findings reported.

Future Directions:

  • AstraZeneca plans to present detailed data from the MATTERHORN trial at upcoming medical meetings and share findings with global regulatory authorities.
  • Ongoing research and development efforts include the exploration of Imfinzi in additional combinations and settings, reflecting a broader strategy to address unmet medical needs in GI cancers.

Conclusion

The MATTERHORN trial results indicate that Imfinzi, when used in combination with standard chemotherapy, can significantly improve event-free survival and pathologic response rates in patients with early-stage gastric and GEJ cancers. This advancement represents a potential shift in treatment paradigms and underscores AstraZeneca's commitment to addressing serious unmet medical needs in oncology.