IMFINZI® (durvalumab) plus chemotherapy significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Phase III trial

First global Phase III trial of immunotherapy and chemotherapy combination to demonstrate clinical benefit in this setting

Trial will continue to assess event-free survival

WILMINGTON, Del.--(BUSINESS WIRE)-- Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI® (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) neoadjuvant (before surgery) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

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

Josep Tabernero, MD, PhD, head of the Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain, and principal investigator of the MATTERHORN trial, 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.”

Susan Galbraith, Executive Vice President, Oncology R&D, 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.”

Gastric cancer is the fourth leading cause of cancer death globally, with more than one million people diagnosed each year.1 By 2030, approximately 70,000 patients in the US, EU and Japan will be newly diagnosed with Stage II-III gastric or GEJ cancers.2 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.3

These data will be shared with health authorities and presented at a forthcoming medical meeting.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

• IMFINZI as a Single Agent
  • In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (

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