ArticleESMO gastrointestinal oncology2026
DKN-01 and atezolizumab as second- or third-line therapy in advanced oesophagogastric adenocarcinoma: the WAKING trial.
Article in ESMO gastrointestinal oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Survival for patients with advanced oesophagogastric adenocarcinoma (OGA) is poor. Immune checkpoint inhibitor (ICI) monotherapy has limited efficacy in mismatch repair proficient (MMRp) OGA. Dickkopf-1 modulates Wnt/β-catenin signalling and promotes an immunosuppressive tumour microenvironment potentially enhancing ICI activity. Patients and methods: This multicentre, single-arm phase II trial occurred in two phases: dose escalation (IIA) and dose expansion (IIB). Phase IIA established the recommended phase II dose of DKN-01. Phase IIB evaluated DKN-01 600 mg i.v. plus atezolizumab 840 mg i.v. administered two-weekly in patients with previously treated MMRp advanced OGA. The primary endpoint was objective response rate (ORR) per RECIST v1.1 (target ORR 25% in 40 patients). Secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). Results: Between June 2022 and May 2024, 61 patients were enrolled; 47 started treatment (5 phase IIA, 42 phase IIB). No dose-limiting toxicities occurred. Forty patients were assessable for the primary endpoint. ORR was 7.5% (3/40) [one-sided 95% lower confidence interval (CI) 2.1], median duration of response 8.6 months (range 2.7-19.4); 13/40 (32.5%; 95% CI 18.6-49.1) had disease control. Baseline programmed death-ligand 1 combined positive score (CPS) in responders was 1, 2, and 85; the patient with CPS 85 remained alive 3 years postprogression. Median PFS was 1.8 months, and median OS was 5.9 months, with a median follow-up of 39.3 months. Grade ≥3 adverse events occurred in 60% of patients. Conclusions: DKN-01/atezolizumab was well tolerated. However, efficacy in MMRp/microsatellite stable OGA in an otherwise biomarker-unselected population did not meet the primary efficacy endpoint.
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