FDA Presses Clinical Hold Button For BioNTech's Partner Late-Stage Trial Of Investigational Lung Cancer Treatment

BioNTech SE BNTX has been notified by its partner, OncoC4 Inc., that the FDA has imposed a partial clinical hold on its Phase 3 PRESERVE-003 trial.

The open-label, randomized study evaluates BNT316/ONC-392 (gotistobart) as a monotherapy in patients with metastatic non-small cell lung cancer (NSCLC) who have previously progressed after PD-(L)1-inhibitor treatment.

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Varying outcomes between patients with squamous and non-squamous NSCLC triggered the partial hold, BioNTech said in its SEC regulatory filing.

Following a review by the independent data monitoring committee, which identified a potential discrepancy in the patient population results, BioNTech and OncoC4 paused new patient enrollment and informed the FDA to align on the next steps.

Patients currently enrolled will continue treatment, while trials of BNT316/ONC-392 for other indications remain unaffected.

Earlier this year, BioNTech’s partner MediLink Therapeutics (Suzhou) Co., Ltd said the FDA placed a partial clinical hold on the Phase 1 trial of BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer.

The clinical trial resumed recruitment in August, focusing on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile and encouraging clinical activity.

Price Action: BNTX stock is down 0.37% at $111.36 at last check Monday.

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