CDSCO approves durvalumab with FLOT for resectable gastric and GEJ cancer in India

AstraZeneca Pharma India announced that the Central Drugs Standard Control Organisation (CDSCO) has approved durvalumab in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) as a perioperative immunotherapy option for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma.

The approval is based on results from the phase III MATTERHORN study and allows the use of durvalumab with FLOT chemotherapy in the neoadjuvant and adjuvant settings, followed by single-agent durvalumab. The regimen represents a perioperative treatment approach intended to address recurrence risk and survival outcomes.

Gastric cancer is reported as the seventh most common cancer in India, with over 64,000 new cases diagnosed each year, and is listed as 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 perioperative chemotherapy is the standard of care. Despite treatment with FLOT, five-year survival remains below 50 per cent, with recurrence occurring within two years of surgery in many cases.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited, 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 perioperative FLOT chemotherapy showed a 28 per cent reduction in the risk of event-free survival events or death compared with FLOT plus placebo, with a hazard ratio of 0.78 and a 95 per cent confidence interval of 0.63 to 0.96 (p=0.021). The study also reported a 21 per cent relative reduction in the risk of death. The safety profile of the combination was consistent with the known profiles of durvalumab and FLOT, with no new safety signals reported.

Durvalumab is a human immunoglobulin G1 kappa monoclonal antibody that blocks the interaction of programmed death-ligand 1 with programmed death-1 and CD80, supporting immune response through T-cell activation. AstraZeneca stated that the use of immunotherapy in the perioperative setting is intended to support treatment approaches in gastrointestinal cancers and patient outcomes in India.