Durvalumab Receives FDA Approval for Resectable Gastric and Gastroesophageal Junction Cancer
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The ‘Curative’ Era Begins in Gastric Cancer
The FDA has approved adding immunotherapy (Durvalumab) to standard chemotherapy (FLOT) in resectable gastric and GEJ cancer. In MATTERHORN, the pathological complete response (pCR) rate increased approximately 3-fold, while recurrence risk fell by 29%.
On 25 November 2025, the US Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) before and after surgery in adults with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, followed by durvalumab alone as continuation treatment after surgery.
This development marked a milestone in the treatment of gastric and gastroesophageal junction (GEJ) cancer. FLOT chemotherapy, our standard approach before and after surgery for many years, now has a powerful new partner: durvalumab.
This approval demonstrates that immunotherapy will be central not only to advanced (metastatic) disease, but also to curative (aiming for cure) treatment.
Why Does This Approval Matter?
- Gastric cancer is an aggressive tumor with a high risk of recurrence despite surgery.
- The standard FLOT regimen is potent, but its rate of complete tumor eradication (pCR, pathological complete response) was around 7%.
- Adding Durvalumab increased this rate to 19%. A higher pathological complete response rate means a greater chance of ‘complete cure’ over the long term.
⛰️ The MATTERHORN Trial
948 Patients participated in this major double-blind, placebo-controlled trial testing the integration of immunotherapy into early-stage treatment.
Result: Marked improvement in all parameters in the arm receiving immunotherapy.
Study Design: Who Was Included?
The FDA approval decision is based on data from one of the largest Phase 3 trials in this field: MATTERHORN . The study’s strength comes from its large patient population and rigorous methodology.
📋 Inclusion Criteria
- Number of Patients: 948 Adult Patients
- Tumor Type: Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
- Stage: Stage II, III or IVA (Resectable/Operable)
- Performance Status: ECOG 0 or 1
- PD-L1 Status: Regardless of status (all expression levels included)
⚔️ Treatment Arms (1:1 Randomization)
Results That Change Clinical Practice
In patients receiving chemotherapy alone, this rate was 7.2% . Immunotherapy produced an almost 3-fold increase .
The risk of recurrence or progression fell significantly (HR: 0.71; p < 0.001).
Overall survival showed a trend toward a 22% reduction in mortality risk (not yet mature, but promising).
The Newly Approved Treatment Protocol
FLOT + Durvalumab (1500mg)
(Every 4 weeks)
Followed by Durvalumab Alone
(Completing a total of 1 year)
👨⚕️ DROZDOGAN Academy Commentary: FLOT alone is no longer the ‘gold standard’. Combining it with Durvalumab increases our patients’ chance of complete tumor eradication (cure) and reduces recurrence risk. This development shows that the immuno-oncology era has officially begun in gastric cancer treatment.
Although adding immunotherapy brings expected immune-related adverse effects (hepatitis, thyroiditis, colitis, etc.), the overall profile is manageable, with no major increase in toxicity that would delay surgery.
- FDA. FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma. 25 November 2025. [Official FDA Announcement]
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