ADC Therapeutics pauses enrollment in cancer drug trial after…
Written by on July 26, 2023
By Raghav Mahobe
July 11 (Reuters) – ADC Therapeutics has paused enrollments to a mid-stage study evaluating its drug to treat a type of blood cancer after seven patients died and five others developed respiratory issues, it said on Tuesday.
Shares sank 21% after the drugmaker said a review of the trial data of 40 patients indicated potentially excessive respiratory-related events.
The trial was testing Zynlonta along with rituximab, a biosimilar drug for Roche’s monoclonal antibody Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma.
An investigator assessment showed 11 of the 12 events, including six of the seven deaths, were assessed as unlikely or unrelated to the study drug, the company said, adding that the cause is being further probed.
The cancer patients who died were aged 80 years or above and had one or more severe respiratory, cardiac conditions such as pulmonary edema and recent COVID-19 infection, ADC said.
TD Cowen analyst Boris Peaker said in a note the safety concerns could be due to the combination with rituximab and that a change in protocol such as lower dose and patient exclusion criteria could be necessary to continue the trial.
Zynlonta was granted an accelerated approval by the U.S.Food and xnxx Drug Administration to treat adults with certain types of large B-cell lymphoma that has come back or that did not respond to previous treatment.
The company is also testing the drug in an ongoing confirmatory trial to show its clinical benefits for full approval in the U.S.
ADC said it does not expect to report more data from the mid-stage trial by the end of the year and has notified all study investigators and regulators, including in Europe where the drug is approved, of its decision to pause enrollment.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Sriraj Kalluvila and Arun Koyyur)
