FDA had placed a partial hold on the phase 1 YL202-INT-101-01 trial sponsored by YL Biotech evaluating YL202 (BNT326), an antibody-drug conjugate (ADC) for treating advanced or metastatic cancers, including EGFR-mutated non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast cancer.
The partial hold was prompted by concerns about the safety of YL202, particularly at higher doses. The FDA identified five cases of severe side effects (grade 5 adverse events) reported in patients receiving higher doses of the drug during the trial.
The FDA emphasized the need for MediLink Therapeutics, the trial’s sponsor, to provide comprehensive data and analyses to address the partial hold and ensure patient safety.
The phase 2 trial (YL202-CN-201-01) remains ongoing and is evaluating the efficacy, safety, and pharmacokinetics of YL202 in a broader range of NSCLC and breast cancer.
As a result of the partial hold, enrollment of new patients in the YL202-INT-101-01 trial within the United States will be paused until the FDA’s concerns are addressed.
The FDA will continue to monitor the development of YL202 and provide updates as they become available.
Source: FDA Places Partial Clinical Hold on Phase 1 Trial of YL202 in Advanced NSCLC and Breast Cancer
https://www.onclive.com/view/fda-places-partial-clinical-hold-on-phase-1-trial-of-yl202-in-advanced-nsclc-and-breast-cancer
