Trial reportThe oncologist2026
Pembrolizumab combined with disitamab vedotin in human epidermal growth factor receptor 2-positive metastatic colorectal cancer.
Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05333809 (Explore the Efficacy and Safety of Pembrolizumab and Disitamab Vedotin in HER2 Expressing Metastatic Colorectal Cancer Failed at Least Two Lines of Systemic Treatment), which is not on this map. Not yet cited in PubMed.
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Explore the Efficacy and Safety of Pembrolizumab and Disitamab Vedotin in HER2 Expressing Metastatic Colorectal Cancer Failed at Least Two Lines of Systemic Treatment
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13 authors.
Funding
Abstract
backgroundLate-line treatment options for microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) are limited. PD-1 blockade alone has minimal clinical benefit in this population. Human epidermal growth factor receptor 2 (HER2)-targeted therapies represent an emerging strategy for HER2-expressing mCRC. This study evaluated the efficacy and safety of pembrolizumab combined with disitamab vedotin (DV), an anti-HER2 antibody-drug conjugate (ADC), in pretreated patients with HER2-positive mCRC.
methodsThis multicenter, single-arm, phase II study enrolled patients with MSS/pMMR, HER2-positive mCRC who received 2 prior lines of systemic therapy. Patients received pembrolizumab 400 mg every 6 weeks plus DV 2.5 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or death. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
resultsBetween December 2022 and May 2024, 15 patients (median age 59.0 years; 60.0% male) were enrolled. Fourteen patients (93.3%) had HER2 IHC 3+ expressions, and 2 had received prior anti-HER2 therapy. Two patients achieved partial response (ORR = 13.3%; 95% CI, 1.7%-40.5%). With a median follow-up of 26.7 months, median PFS was 2.9 months (95% CI, 2.3 to not reached). Median OS was not reached (95% CI, 16.7 to NR). The 6-month OS rate was 92.9% (95% CI: 6.9%-80.3%), and the 1-year OS rate was 71.4% (95% CI: 51.3%-99.5%). The most common treatment-related adverse events (TRAEs) included nausea, anorexia, alanine aminotransferase elevation, aspartate aminotransferase elevation, and alopecia. Grade 3-4 TRAEs occurred in 2 patients (14.3%), both neutropenia.
conclusionsPembrolizumab plus disitamab vedotin showed limited antitumor activity in pretreated HER2-positive mCRC. CLINICALTRIALS.GOV IDENTIFIER: NCT05333809.
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