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Blood Cancer Drug Trial Sees Higher Death Rate
4 Jun
Summary
- ADC Therapeutics drug Zynlonta shows more deaths in trial.
- The study tested Zynlonta with Rituxan for aggressive blood cancer.
- Company plans FDA meeting in August for full approval.
ADC Therapeutics experienced a significant stock drop of nearly 53% in premarket trading on Thursday, June 4. This decline followed the release of late-stage study results for its blood cancer drug, Zynlonta.
The confirmatory study evaluated Zynlonta in combination with Roche's Rituxan. It targeted patients with relapsed or refractory diffuse large B-cell lymphoma, an aggressive form of blood cancer.
While the trial met its primary endpoint of improving progression-free survival, safety concerns emerged. The treatment arm experienced 27 deaths (13.2%), compared to 9 deaths (4.6%) in the control group that received Rituxan and chemotherapy. Most deaths occurred in patients aged 75 or older.
ADC Therapeutics plans to engage with the U.S. Food and Drug Administration (FDA) in August. A supplemental application for full approval is targeted for submission in the fourth quarter of 2026.
The company attributed the higher death rate partly to an older patient population and longer monitoring periods for adverse events. Patients in the treatment arm also remained on therapy longer.
