China-based Zhejiang Wenda Pharmaceutical Technology Co Ltd announced on Sunday the publication of its phase II clinical trial data for NHWD-870 HCl, an oral BET inhibitor, in Chinese patients with advanced NUT carcinoma (NC) at the 2026 ESMO Annual Meeting.
In this multicentre, open-label, single-arm phase II study, patients with advanced NC received oral NHWD-870 HCl 2 mg on a 5-days-on/2-days-off schedule in 28-day cycles until disease progression or intolerable adverse events. The primary endpoint was objective response rate (ORR) per RECIST v1.1. Secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
The most common treatment-related adverse events were decreased platelet count (55.0%), hypertriglyceridemia (55.0%), increased blood bilirubin (47.5%), and anaemia (47.5%). No treatment-related deaths occurred.
According to Wenda Pharma, NHWD-870 HCl demonstrated promising antitumour activity with a manageable safety profile in patients with advanced NC. These findings support further clinical investigation of NHWD-870 HCl in this rare malignancy with substantial unmet need.
NHWD-870 HCl is a novel oral BET inhibitor developed by Wenda Pharma. Its mechanism of action is to competitively bind to the bromodomains (BD1, BD2) of BRD4 or BRD3, causing the dissociation of BRD4/3 from the MYC enhancer, thereby down-regulating the expression of the MYC gene, inhibiting the related tumour-promoting transcription factors, and subsequently suppressing the proliferation of cancer cells.
Based on the positive Phase II results, China's National Medical Products Administration (NMPA) officially granted breakthrough therapy designation (BTD) to NHWD-870 HCl in May 2026, and the proposed indication is for advanced thoracic NUT carcinoma that has failed previous chemotherapy.
Alnylam reports positive Phase 1b results for brezosiran in Huntington's disease
Zai Lab reports promising Phase 1b results for zocilurtatug pelitecan in small cell lung cancer
HUYABIO International reports positive Phase 3 trial results for HBI-8000 and nivolumab combination
NFL Biosciences secures regulatory approval to launch Phase 2 trial of NFL-102
Lynch Regenerative Medicine's Phase IIb clinical trial of rhPDGF-BB injection cleared by FDA
European Commission approves Novartis' Cosentyx for polymyalgia rheumatica
GSK wins US FDA approval for chronic hepatitis B treatment Hibsago