(Reuters) -BioNTech SE said on Friday it has been informed by its partner OncoC4 that the U.S. Food and Drug Administration has lifted the partial clinical hold on a late-stage trial studying its drug for a type of lung cancer.
In October, a partial clinical hold was placed on the trial studying the drug, gotistobart, in some lung cancer patients after an assessment of the trial data by an independent data monitoring committee.
The committee identified a potential disparity in results between the squamous and non-squamous non-small cell lung cancer (NSCLC) patients.
Based on the available trial data and following an alignment with the FDA, the companies said they will solely continue enrollment of patients with squamous NSCLC.
NSCLC is the most common type of lung cancer.
Squamous NSCLC originates in the thin, flat cells that line the airways and typically forms in the central region of the lungs, whereas non-squamous NSCLC usually begins in the peripheral lung tissue.
The partial clinical hold only affected new patient enrollment, with no impact to patients already enrolled in the trial.
Other trials studying gotistobart in other diseases also remained unaffected, the companies said.
(Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona)
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