#China #Shaoxing #NUT Carcinoma #Wenda Pharma #NHWD-870 HCl

Encouraging Results from Phase II Trial of NHWD-870 HCl by Wenda Pharma

At the 2026 ESMO Annual Meeting, Zhejiang Wenda Pharmaceutical Technology Co., Ltd. unveiled the promising results from a Phase II trial concerning its oral BET inhibitor, NHWD-870 HCl. This trial focuses on treating advanced NUT carcinoma (NC) in Chinese patients, a rare and aggressive form of cancer characterized by NUTM1 rearrangements.

Overview of the Trial

The Phase II clinical trial was designed as a multicenter, open-label, single-arm study. Patients received NHWD-870 HCl at a dosage of 2 mg, administered on a 5-days-on and 2-days-off schedule in 28-day cycles. Patients continued the treatment until disease progression or the emergence of intolerable side effects.

The trial aimed to achieve several primary and secondary endpoints. The primary endpoint revolved around the objective response rate (ORR) which was assessed using the RECIST v1.1 criteria. Meanwhile, secondary endpoints included progression-free survival (PFS), overall survival (OS), and the safety profile of the treatment.

Results Breakdown

By December 27, 2025, a total of 40 patients were enrolled in the study. The average age of participants was 42.2 years, with a notable demographic of 62.5% males. According to the assessments made by the independent radiologic review committee, the results showed an ORR of 30.0%, meaning 12 out of 40 patients experienced tumor response. Furthermore, the disease control rate (DCR) was recorded at 47.5%, indicating that nearly half of the participants had their disease controlled during the treatment.

The median progression-free survival and overall survival were reported at 2.76 and 9.33 months, respectively. A subgroup analysis revealed that patients with primary thoracic tumors demonstrated a higher ORR of 45.0%, translating into 9 out of 20 patients showing positive responses to treatment.

While the findings indicate promising results, the trial also noted common treatment-related adverse events (TRAEs). The most frequently reported issues included decreased platelet count (55.0%), hypertriglyceridemia (55.0%), elevated blood bilirubin levels (47.5%), and anemia (47.5%). Crucially, there were no treatment-related fatalities during the trial period.

Implications and Future Directions

The outcomes of this Phase II trial suggest that NHWD-870 HCl holds notable antitumor activity along with an acceptable safety profile in patients grappling with advanced NUT carcinoma. This significant data supports the call for further clinical investigations into NHWD-870 HCl, a drug that could be pivotal for patients afflicted by a rare cancer type characterized by considerable unmet medical needs.

Understanding NUT Carcinoma

NUT carcinoma is recognized for its rapid progression, making it exceedingly challenging to treat. Although it predominantly occurs in the lungs and head/neck regions, its complex clinical manifestations often lead to misdiagnoses. Most patients receive a diagnosis at an advanced stage, and the median survival concerning this malignancy is alarmingly low at merely 6.7 months as per literature reports.

Currently, there are no globally approved targeted therapies for this aggressive cancer, amplifying the importance of new options like NHWD-870 HCl.

About NHWD-870 HCl

NHWD-870 HCl is a groundbreaking oral BET inhibitor developed by Wenda Pharma. Its mechanism involves competitively binding to the bromodomains of BRD4 or BRD3, disrupting their interaction with the MYC enhancer, consequently inhibiting tumor-promoting transcription factors and suppressing the growth of cancerous cells. Given the positive Phase II results, the China National Medical Products Administration (NMPA) granted NHWD-870 HCl breakthrough therapy designation on May 9, 2026, for advanced thoracic NUT carcinoma, offering fresh hope to patients undergoing challenging treatment journeys.

About Wenda Pharma

Founded in 2013 and based in Shaoxing City, China, Wenda Pharma is focused on pioneering drug development across oncology, immunology, and neurodegenerative diseases. The promising outcomes of NHWD-870 HCl place it in a prime position to potentially become the first oral BET inhibitor aimed at treating NUT carcinoma. The company’s innovation pipeline also includes other candidates progressing through various trial phases, further cementing its commitment to advancing treatment options in critical areas of healthcare.