Wenda Pharma's Phase II Trials Show Promising Outcomes for NHWD-870 HCl Against NUT Carcinoma

Promising Developments from Zhejiang Wenda Pharma's Phase II Trial

At the forefront of oncology advancements, Zhejiang Wenda Pharmaceutical Technology Co., Ltd., also known as Wenda Pharma, recently announced noteworthy results from their Phase II clinical trial of NHWD-870 HCl. This oral BET inhibitor was specifically developed for patients suffering from advanced NUT carcinoma (NC). The findings were unveiled at the 2026 ESMO Annual Meeting, drawing significant attention from the medical community.

Overview of the Trial

The Phase II trial, designed as a multicenter, open-label, single-arm study, focused on Chinese patients diagnosed with advanced NUT carcinoma. The study's protocol administered NHWD-870 HCl at a dosage of 2 mg, managed on a schedule of five days on treatment followed by two days off, repeated in cycles of 28 days. Treatment continued until either disease progression occurred or patients experienced intolerable adverse effects.

The primary measure for success was the objective response rate (ORR) according to RECIST v1.1, while secondary measures included progression-free survival (PFS), overall survival (OS), and safety assessments.

Key Findings

As of December 27, 2025, the study had enrolled 40 patients with a mean age of 42.2, and interestingly, 62.5% of participants were male. According to an independent radiologic review committee, key outcomes revealed an ORR of 30.0% (12 out of 40 patients) and a disease control rate (DCR) of 47.5% (19 out of 40). For those patients specifically with primary thoracic tumors (20 individuals), the ORR improved to 45.0% (9 out of 20). Moreover, participants achieved median PFS and OS values of 2.76 months and 9.33 months, respectively.

While the treatment was generally well-received, common treatment-related adverse events included decreased platelet counts (55.0%), hypertriglyceridemia (55.0%), increased blood bilirubin levels (47.5%), and anemia (47.5%). Notably, there were no treatment-related fatalities reported during the study.

Implications of the Results

The outcomes showcase NHWD-870 HCl’s potential effectiveness and manageable safety profile in treating a challenging and rare malignancy like NUT carcinoma. Given the aggressive nature of NC, which often presents with a grim prognosis, these results offer a glimmer of hope and support further clinical investigations.

Understanding the gravity of NUT carcinoma, characterized by rapid progression and high mortality, this trial's results are not merely statistical victories but represent crucial advancements towards targeted therapies that have long been elusive for patients.

Background on NUT Carcinoma

NUT carcinoma is recognized as a rare, highly malignant form of cancer typically related to NUTM1 gene rearrangements. Its aggressive nature means that median survival rates hover around 6.7 months—a tragic reality for many affected individuals. Primarily manifesting in the lungs or head and neck region, the disease can often lead to misdiagnoses, as its symptoms can be non-specific, further complicating treatment at already advanced stages.

The Future of NHWD-870 HCl

The mechanisms underpinning NHWD-870 HCl's efficacy hinge on its action as a BET inhibitor. By binding competitively to the bromodomains (BD1, BD2) of proteins like BRD4 or BRD3, it disrupts pivotal tumor-promoting transcription factors tied to the MYC gene, presenting a promising avenue for cancer therapy tailored for harsh malignancies.

In light of these Phase II results, the China National Medical Products Administration (NMPA) has granted NHWD-870 HCl breakthrough therapy designation as of May 9, 2026. This designation is a significant step toward establishing NHWD-870 HCl as a pivotal treatment for patients battling advanced thoracic NUT carcinoma who haven't found relief through prior chemotherapy regimens.

About Wenda Pharma

Founded in 2013 and based in Shaoxing City, China, Wenda Pharma is dedicated to pioneering innovative drug development in the realms of oncology, immunology, and neurodegenerative conditions. Their evolving pipeline features multiple candidates currently undergoing various phases of clinical trials. The promising results from the NHWD-870 HCl program position it as a potential first-in-class oral BET inhibitor targeted for NUT carcinoma patients, embodying new hope in the fight against such formidable cancers.

For further information on Wenda Pharma and their ongoing research efforts, please visit www.wendapharma.com.