Zhejiang Wenda Pharma reports Phase II BET inhibitor trial data

SHAOXING, China, Oct. 25, 2026 /PRNewswire/ -- At the 2026 ESMO Annual Meeting, Zhejiang Wenda Pharmaceutical Technology Co., Ltd. ("Wenda Pharma") will publish the phase II clinical trial data for NHWD-870 HCl, an oral BET inhibitor, in Chinese patients with advanced NUT carcinoma (NC).

In this multicenter, 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.

Results:

As of 27 December 2025, 40 patients had been enrolled. The mean age was 42.2 years, and 62.5% were male. Based on independent radiologic review committee assessment, the ORR was 30.0% (12/40), and the disease control rate (DCR) was 47.5% (19/40). Median PFS and OS were 2.76 and 9.33 months, respectively. In the subgroup of 20 patients with primary thoracic tumors, the ORR was 45.0% (9/20). The most common treatment-related adverse events (TRAEs) were decreased platelet count (55.0%), hypertriglyceridemia (55.0%), increased blood bilirubin (47.5%), and anemia (47.5%). No treatment-related deaths occurred.

NHWD-870 HCl demonstrated promising antitumor 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.

NUT carcinoma (NC) is a rare, highly aggressive malignancy defined by NUTM1 rearrangements. The disease progresses rapidly, with a median survival of only about 6.7 months according to literature reports ^[1]. It predominantly occurs in the lungs or head & neck regions, with a median age of onset as low as 23.6 years. Due to its nonspecific clinical manifestations and limited public awareness, misdiagnoses are extremely common, and most patients are diagnosed at an advanced stage. Currently, there are no effective targeted therapies approved globally for NUT carcinoma, making the treatment particularly challenging.

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 tumor-promoting transcription factors, and subsequently suppressing the proliferation of cancer cells.

Based on these positive Phase II results, the China National Medical Products Administration (NMPA) had officially granted breakthrough therapy designation (BTD) to NHWD-870 HCl on May 9, 2026, and the proposed indication is for advanced thoracic NUT carcinoma that has failed previous chemotherapy. This landmark progress has brought new hope for targeted therapy to patients with NUT carcinoma, a tumor characterized by extremely high malignancy and poor prognosis.

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