(HER2-Positive Solid Tumors) Is Trastuzumab Duocarmazine Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- August 28, 2019
- Read time: 2 minutes
On June 27, 2019, Udai Banerji published in The Lancet Oncology "Safety and efficacy verification of anti-HER2 monoclonal antibody drug trastuzumab duocarmazine (SYD985) monotherapy in HER2-positive locally advanced solid tumor patients in a Phase 1 clinical trial."
The Phase 1 clinical trial administered trastuzumab duocarmazine (SYD985) 0.3–2.4 mg/kg as monotherapy on a 3-week cycle to HER2-positive locally advanced solid tumor patients, continued until disease progression or unexpected adverse events. The primary endpoints were safety and objective response rate.
The background for this trial was that antitumor activity of the novel anti-HER2 monoclonal antibody drug trastuzumab duocarmazine (SYD985) had already been confirmed in preclinical studies. Therefore, this trial evaluated whether it would be effective in HER2-positive locally advanced solid tumor patients.
Trial results showed that dose-limiting toxicity was observed at 2.4 mg/kg, where one patient died due to pneumonia. At the 1.5 mg/kg dose, another patient died due to disease progression. Grade 3–4 adverse events included keratitis in 3 patients and fatigue in 1 patient. Based on these results, 1.2 mg/kg was selected for the Phase 2 clinical trial.
For the primary endpoint, the objective response rate in HER2-positive breast cancer patients (N=48) was 33%. In HER2 non-overexpressing hormone receptor-positive breast cancer patients (N=32) it was 28%, and in HER2 non-overexpressing hormone receptor-negative breast cancer patients (N=16) it was 40%.
For other cancer types: gastric cancer patients (N=16) 6%, urothelial cancer patients (N=16) 25%, endometrial cancer patients (N=13) 39%.
Based on the Phase 1 clinical trial results, Udai Banerji concluded: In HER2-positive locally advanced solid tumor patients, trastuzumab duocarmazine (SYD985) monotherapy demonstrated favorable antitumor activity in heavily pretreated patients.
[Important Note] Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.
Source: Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study. (Lancet Oncol. 2019 June 27. pii: S1470-2045(19)30328-6. doi: 10.1016/S1470-2045(19)30328-6.)
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