The US Food and Drug Administration (FDA) has lifted a partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a promising HER3-targeting antibody-drug conjugate (ADC) designed to treat certain types of cancer. This decision, announced on August 15th, allows the trial to move forward with adjusted dose levels after MediLink addressed the FDA’s concerns regarding potential safety risks.
The MediLink-sponsored trial is evaluating BNT326/YL202 as a late-line treatment option for patients with advanced or metastatic non-small cell lung cancer (NSCLC) or breast cancer who have not responded to other treatments. The FDA had initially placed the hold in June 2024 after expressing concerns that higher doses of the drug could pose an unreasonable risk to patients. These concerns stemmed from observed treatment-related adverse events (TRAEs) such as neutropenia (low neutrophil count) and mucositis (inflammation of the lining of the mouth, digestive tract, or other mucous membranes).
To address these concerns, MediLink and BioNTech SE (BNTX), a collaborator on the project, took proactive steps. These included halting patient enrollment in dose cohorts exceeding 3 mg/kg and reducing doses for participants who had already been enrolled at higher levels.
The FDA’s decision to lift the hold is a significant step forward for the development of BNT326/YL202. The trial will now resume, focusing on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile and encouraging clinical activity. This approach will allow researchers to continue exploring the potential of BNT326/YL202 as a promising treatment option for patients with difficult-to-treat cancers while ensuring patient safety remains paramount.
With the FDA’s approval, MediLink and BioNTech are set to resume clinical development under the revised guidelines. This represents a commitment to both patient safety and the pursuit of potentially life-saving therapies.
