Oncology News Central (ONC)ADC Therapeutics Pauses Enrollment in Cancer Drug Trial After Patient Deaths

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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As of 2021, the estimated five-year survival rate for patients with DLBCL was about 63%.