Trial reportESMO open2026
Efficacy and safety of trastuzumab emtansine in patients with advanced human epidermal growth factor receptor 2-positive extramammary Paget's disease: an investigator-initiated, open-label, single-arm, multicentre, prospective, phase II clinical trial (TEMENOS-2).
Trial report in ESMO open, 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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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExtramammary Paget's disease (EMPD) is a rare cutaneous adenocarcinoma with no established standard systemic therapy owing to limited clinical evidence. Approximately 40% of metastatic EMPD cases overexpress human epidermal growth factor receptor 2 (HER2), suggesting a potential therapeutic target. However, prospective evidence for HER2-directed antibody-drug conjugates (ADCs) in advanced EMPD is lacking. This study aimed to assess the efficacy and safety of trastuzumab emtansine (T-DM1) in patients with HER2-positive advanced EMPD. PATIENTS AND
methodsThis investigator-initiated, open-label, single-arm, multicentre, prospective phase II trial enrolled Japanese patients with HER2-positive metastatic EMPD who had not received prior HER2-targeted therapy. Patients received intravenous T-DM1 at 3.6 mg/kg every 3 weeks for up to 2 years. The primary endpoint was objective response rate (ORR) assessed by independent central review. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.
resultsFourteen patients were enrolled and received study treatment between December 2021 and July 2024. The median age was 65 (range: 42-80) years. Thirteen patients had an Eastern Cooperative Oncology Group performance status of 0, and 12 had distant metastases at baseline. The ORR assessed by central review was 92.9% [95% confidence interval (CI) 66.1%-99.8%], with best responses of complete response (n = 2), partial response (n = 11), and progressive disease (n = 1). Median OS was not reached, whereas median PFS was 16.95 months (95% CI 5.75 months-not applicable). Grade 3 adverse events occurred in 6 (42.9%) patients. No grade ≥4 adverse events were observed, and one patient discontinued treatment due to grade 1 interstitial lung disease.
conclusionsThis study provides the first prospective clinical evidence supporting the efficacy and safety of a HER2-directed ADC in HER2-positive advanced EMPD. T-DM1 demonstrated robust antitumour activity with a tolerable safety profile in this predominantly older adult population.
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