Durvalumab added to chemotherapy improves pathological complete response rate in the perioperative setting for patients with gastric cancer.
Perioperative FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has become the standard of care in resectable GC/GEJC.1 However, approximately 50% of patients eventually will relapse. A combination of PD-1 blockade and chemotherapy is the standard first-line treatment in advanced/metastatic GC/GEJ.2
The global, phase 3, randomized, double-blind, placebo-controlled MATTERHORN trial (NCT04592913) assesses perioperative durvalumab with FLOT in participants with resectable GC/GEJ. Dr. Salah-Eddin Al-Batran of the Institute of Clinical Cancer Research IKF at Northwest Hospital Frankfurt, Germany, presented the results of a pre-planned interim analysis.3
The MATTERHORN trial randomized 948 participants with resectable stage III-IVA gastric or gastroesophageal adenocarcinoma 1:1 to perioperative FLOT (4 doses before, 4 doses after surgery) or FLOT plus durvalumab (2 doses before, 2 doses after surgery). Thereafter, durvalumab and placebo were continued for 10 doses. The primary outcome of MATTERHORN is event-free survival. One of the secondary outcomes is the pCR rate.
The addition of durvalumab to FLOT significantly increased the pCR rate from 7% to 19% (absolute difference, 12%; odds ratio [OR], 3.08; 95% CI, 2.03-4.67; P<.00001). Likewise, durvalumab significantly increased combined pathological complete and near-complete response rate: 14% versus 27% (absolute difference, 12%; OR, 2.19; 95% CI, 1.58-3.04; P<.00001). In the durvalumab arm, more participants presented with downstaging (T0: 23% vs 11%, N0: 52% vs 37%). No unexpected safety signals were observed.
Based on these outcomes, Dr. Al-Batran concluded: “Perioperative treatment with durvalumab plus FLOT leads to a significant improvement of pathological response versus FLOT alone and a significant improvement of downstaging. However, while the results are promising, the event-free survival data are required before any impact on clinical practice can be suggested.”
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