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Wenda Pharma's oral BET inhibitor shows responses in NUT carcinoma trial

Wenda Pharma's oral BET inhibitor shows responses in NUT carcinoma trial

New Capabilities

Oral drug posts 30% response rate and 9.33-month median survival in advanced NUT carcinoma

Yesterday: Phase II results presented at ESMO 2026

Overview

Updated 1 hour ago

NUT carcinoma is a rare, aggressive cancer with no targeted therapy and a median survival measured in months. At the European Society for Medical Oncology's (ESMO) 2026 annual meeting on October 24, Zhejiang Wenda Pharma reported its oral drug NHWD-870 produced a 30% response rate in a 40-patient Phase II trial. Among 20 patients whose tumors began in the chest, the response rate was 45%.

Median overall survival reached 9.33 months at the December 2025 data cutoff. China's National Medical Products Administration (NMPA) granted the drug breakthrough therapy designation in May 2026, an accelerated review path for serious conditions. NHWD-870 blocks BRD4, a protein that drives the disease by amplifying the MYC oncogene; approval would make it the first targeted therapy for NUT carcinoma in China.

Why it matters

NUT carcinoma patients have no targeted therapy and a median survival under a year; a working oral drug changes what treatment can offer them.

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Key Indicators

30%
Objective response rate (Phase II)
12 of 40 advanced NUT carcinoma patients had confirmed tumor responses.
45%
Response rate, thoracic tumor subgroup
9 of 20 patients with primary thoracic NUT carcinoma responded.
9.33 months
Median overall survival
Across all 40 patients at the December 2025 data cutoff.
47.5%
Disease control rate
19 of 40 patients had tumor shrinkage or stable disease.
2.76 months
Median progression-free survival
Time before tumor growth or death in the trial population.

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Organizations Involved

ZW
Zhejiang Wenda Pharmaceutical Technology Co., Ltd. (Wenda Pharma)
Pharmaceutical Company
Developer of NHWD-870; reported Phase II results at ESMO 2026

Chinese biotech developing NHWD-870, an oral BET inhibitor for NUT carcinoma and other cancers.
National Medical Products Administration (NMPA)
National Medical Products Administration (NMPA)
Regulatory Agency
Granted breakthrough therapy designation to NHWD-870 in May 2026

China's drug regulator, responsible for approving and supervising medicines for the Chinese market.

Timeline

December 2023 October 2026

7 events Latest: Yesterday
Tap a bar to jump to that date

  1. Phase II results presented at ESMO 2026

    Latest Conference

    Wenda Pharma presents full Phase II data on NHWD-870 at the annual ESMO meeting.

  2. NMPA grants breakthrough therapy designation

    Regulatory

    China's drug regulator designates NHWD-870 for advanced thoracic NUT carcinoma that failed prior chemotherapy.

  3. Phase II data cutoff: 40 patients enrolled

    Clinical Data

    Response rate 30%, disease control rate 47.5%, median overall survival 9.33 months.

  4. Complete response after four months

    Case Report

    Imaging shows a complete response in the case report patient; surgery later finds no residual cancer cells.

  5. Phase II trial opens in China

    Clinical Trial

    Wenda Pharma opens a multicenter, open-label, single-arm Phase II study (NCT06527300) in adults and adolescents with advanced NUT cancer.

  6. Patient starts NHWD-870 treatment

    Case Report

    The case report patient begins NHWD-870 monotherapy at 2 mg daily, 5 days on / 2 days off.

  7. Case report: stage IIIB NUT carcinoma diagnosis

    Case Report

    A 36-year-old woman is diagnosed with stage IIIB pulmonary NUT carcinoma, a disease with no targeted standard therapy.

Scenarios

1

NMPA approves NHWD-870 for advanced NUT carcinoma

Likely Resolves by End of 2027

Discussed by: Wenda Pharma announcements; China's conditional approval pathway for unmet medical needs

The breakthrough therapy designation puts NHWD-870 on an accelerated review. Phase II data in a disease with no targeted options could support a conditional approval filing, with a post-market confirmatory trial likely required. Approval would give Chinese NUT carcinoma patients their first targeted oral therapy.

2

Wenda Pharma launches confirmatory Phase III trial

Possible Resolves by Q2 2027

Discussed by: Standard regulatory expectation after conditional approval; company pipeline statements

Conditional approvals in China often carry a commitment to confirm benefit in a larger trial. Registration of a Phase III study on a clinical trial database would signal that commitment and support international filings. A broader BET-inhibitor indication would expand the patient population beyond NUT carcinoma.

3

NMPA asks for more data; NHWD-870 approval delayed

Unlikely Resolves by End of 2027

Discussed by: BET inhibitor safety profile; regulatory caution

Over half of trial patients had low platelet counts or high triglycerides, known effects of BRD4 inhibition. If the regulator judges the safety picture needs more evidence, it could require longer follow-up or a larger safety database before any approval decision.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

May 2001

Imatinib (Gleevec) for chronic myeloid leukemia (2001)

The FDA approved imatinib, the first drug built to block a specific cancer-driving protein, the BCR-ABL fusion that causes chronic myeloid leukemia. Before imatinib, CML had a median survival of roughly three to five years; most patients treated early achieved lasting remission.

Then

Imatinib became the standard of care, and CML survival climbed toward near-normal.

Now

It established the paradigm of molecularly targeted therapy for fusion-driven cancers.

Why this matters now

NHWD-870 targets the BRD4-NUT fusion that defines NUT carcinoma, applying the same logic that worked in CML: identify the driver protein, block it.

November 2018

Larotrectinib (Vitrakvi) for NTRK fusion cancers (2018)

The FDA approved larotrectinib for any solid tumor carrying an NTRK gene fusion, the first tumor-agnostic cancer drug. Across tumor types, the majority of patients responded regardless of where the cancer originated.

Then

Larotrectinib became a treatment option for rare fusion-driven cancers previously treated with standard chemotherapy.

Now

It set a precedent for matching rare genetic drivers with targeted drugs across tumor types.

Why this matters now

NUT carcinoma, like NTRK fusion cancers, is rare, genetically defined, and historically treated with chemotherapy. Larotrectinib showed a small patient population can still get a molecularly matched therapy.

2015-2024

BET inhibitor clinical development (2015-2024)

BET inhibitors from Bristol Myers Squibb and others entered clinical trials starting in the mid-2010s. Many faced on-target toxicity, since BRD4 inhibition cuts platelet production, and several showed limited efficacy. BMS-986158 demonstrated responses in NUT carcinoma but with the same platelet effects.

Then

Several BET inhibitors advanced into later trials in NUT carcinoma and other solid tumors.

Now

Intermittent dosing schedules and more selective inhibitors are being explored to manage toxicity while preserving efficacy.

Why this matters now

NHWD-870's Phase II response rate, achieved on an intermittent schedule with manageable toxicity, stands out in a drug class where safety has repeatedly limited development.

Sources

(7)
+2
PRNewswire ClinicalTrials.gov PMC / NCBI Wenda Pharma CCC Health Platform PRNewswire PRNewswire