AstraZeneca Pharma India, a global, science-led biopharmaceutical company, announces the Central Drugs Standard Control Organisation (CDSCO) approval for Durvalumab in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) as the first and only perioperative immunotherapy approach for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), showing survival benefit.
Based on the results from the phase III MATTERHORN study, the approval allows the addition of Durvalumab to FLOT chemotherapy for patients in the neoadjuvant and adjuvant settings, followed by single agent durvalumab, reflecting a comprehensive perioperative approach aimed at reducing recurrence risk and improving long-term outcomes.
Gastric cancer remains a major health challenge in India, ranking as the seventh most common cancer with over 64,000 new cases diagnosed annually, and the sixth leading cause of cancer-related deaths. Around half of gastric and gastroesophageal junction cancers are diagnosed at a resectable stage, where surgery combined with peri-operative chemotherapy is the standard of care. Despite treatment with FLOT, five-year survival remains below 50%, and recurrence rates are high within two years of surgery, underscoring the need for more effective peri-operative options.
Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India said, “We are transforming cancer care in India. Patients with resectable gastric and gastroesophageal junction cancers face high recurrence risk. Backed by the MATTERHORN study, this approval brings immunotherapy earlier in the treatment pathway, significantly improving survival. This milestone advances our purpose to address unmet needs and demonstrates the power of science-led innovation at earlier stages, where the potential for cure is greatest.”
In the MATTERHORN study, the addition of durvalumab to peri-operative FLOT chemotherapy demonstrated a 28% reduction in the risk of event-free survival events or death compared with FLOT plus placebo (hazard ratio [HR] 0.78; 95% confidence interval [CI] 0.63–0.96; p = 0.021). The study also showed a 21% relative reduction in the risk of death, supporting a meaningful overall survival benefit. The combination was well tolerated, with a safety profile consistent with the known profiles of durvalumab and FLOT, and no new safety signals identified.
Durvalumab is a human immunoglobulin G1 kappa (IgGκ) monoclonal antibody that selectively blocks the interaction of programmed death-ligand 1 (PD-L1) with programmed death-1 (PD-1) and CD80, enhancing anti-tumour immune responses through T-cell activation. By optimising immunotherapy use in the peri-operative setting, AstraZeneca aims to redefine standards of care in gastrointestinal cancers and improve long-term outcomes for patients in India.