Phase II data at ESMO 2026
Zhejiang Wenda Pharmaceutical Technology, known as Wenda Pharma, will publish Phase II trial data for NHWD-870 HCl at the 2026 ESMO Annual Meeting. The drug is an oral BET inhibitor and the trial enrolled Chinese patients with advanced NUT carcinoma, the company said. The study was multicentre, open-label and single-arm, with patients taking a 2 mg oral dose on a five-days-on, two-days-off schedule across 28-day cycles until disease progression or intolerable adverse events. Objective response rate under RECIST v1.1 was the primary endpoint, and progression-free survival, overall survival and safety were secondary endpoints.
Response and survival
As of 27 December 2025, 40 patients had been enrolled. The mean age was 42.2 years and 62.5% of patients were male. Assessment by an independent radiologic review committee put the objective response rate at 30.0% (12/40) and the disease control rate at 47.5% (19/40). Median progression-free survival was 2.76 months and median overall survival 9.33 months. In the subgroup of 20 patients whose primary tumours were thoracic, the objective response rate was 45.0% (9/20).
Safety findings
The most common treatment-related adverse events were decreased platelet count and hypertriglyceridemia, each reported in 55.0% of patients, followed by increased blood bilirubin and anemia at 47.5% each. No treatment-related deaths occurred. Wenda Pharma said the findings supported further clinical investigation of NHWD-870 HCl in this rare malignancy.
Breakthrough designation in China
The China National Medical Products Administration granted breakthrough therapy designation to NHWD-870 HCl on 9 May 2026, based on the Phase II results, according to Wenda Pharma. The proposed indication is advanced thoracic NUT carcinoma that has failed previous chemotherapy. The company said NUT carcinoma is a rare, highly aggressive malignancy defined by NUTM1 rearrangements, with a median survival of about 6.7 months according to literature it cited, and that no effective targeted therapies for it are approved globally.