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GUIDELINES/RECOMMENDATIONS On July 11, 2023, ADC Therapeutics announced the suspension of enrollments in a mid-stage study of its blood cancer drug, following the death of seven patients and respiratory complications in five others.
ADC Therapeutics has put its mid-stage trial of Zynlonta, a drug for a type of blood cancer, on hold following unexpected patient complications and fatalities.
Key Points:
- The trial was assessing the combined use of Zynlonta and rituximab, a biosimilar drug, in treating unfit or frail patients with untreated diffuse large B-cell lymphoma.
- ADC Therapeutics reported that of the 12 serious adverse events, 11 were deemed unlikely or unrelated to the study drug.
- All patients who died were more than 80 years old with severe respiratory, cardiac conditions, or recent COVID-19 infections.
- Zynlonta previously received an accelerated approval from the FDA for specific types of large B-cell lymphoma.
Additional Points:
- TD Cowen analyst Boris Peaker suggests that the safety issues may stem from the combination with rituximab and changes may be needed to continue the trial.
- The company is also conducting a confirmatory trial for Zynlonta to demonstrate its clinical benefits for full US approval.
- ADC does not expect further data from the mid-stage trial this year and has notified all investigators and regulators, including in Europe.
Conclusion:
- In light of serious adverse events during a mid-stage trial, ADC Therapeutics has suspended the testing of Zynlonta, despite the drug having received accelerated approval from the FDA for certain types of large B-cell lymphoma.
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Did You Know?
As of 2021, the estimated five-year survival rate for patients with DLBCL was about 63%.
