FDA Lifts Partial Hold for Phase 2 Trial of R/R Hodgkin Lymphoma Therapy

FDA has lifted a partial clinical hold on a phase 2 trial of a treatment for patients with relapsed or refractory Hodgkin lymphoma (HL) from ADC Therapeutics. The trial of camidanlumab tesirine (Cami), an antibody drug conjugate that binds to CD25, included 100 patients in a multicenter, open-label, single-arm trial.

“The ADC Therapeutics team worked diligently to provide a thorough and prompt response to the FDA following its request for information about our pivotal Phase 2 clinical trial of Cami,” Jay Feingold, MD, PhD, senior vice president and chief medical officer of ADC Therapeutics, said in a statement. “During the partial clinical hold we continued to treat patients benefiting from Cami, and now look forward to resuming the enrollment of new patients in the trial as soon as possible.”

The clinical trial includes patients with relapsed or refractory HL who have failed 3 previous lines of therapy. The phase 2 trial is evaluating the safety and efficacy of Cami and is intended to support the submission of a Biologics License Application to the FDA.

“While advances have been made in the treatment of HL, a significant unmet medical need remains in the relapsed or refractory HL patient population, especially patients who have progressed following treatment with other novel agents. I believe ADCT-301 has the potential to fill this important medical need,” Alex Herrera, MD, assistant professor, Department of Hematology/Hematopoietic Cell Transplantation at City of Hope Medical Center and an investigator for the trial, said in a statement.

In June 2019, ADC presented promising phase 1 data on Cami (formerly ADCT-301) at the 15th International Conference on Malignant Lymphoma, held in Lugano, Switzerland. In a phase 1 clinical trial subgroup analysis of Cami in patients with relapsed/refractory classical HL, 77 patients were evaluated for safety and 75 patients for efficacy.

The subgroup analysis found that the recommended dose of Cami for the phase 2 trial was 45 μg/kg every 3 weeks dosed for 2 cycles followed by 30 μg/kg every 3 weeks to improve tolerability while maintaining anticancer activity. The overall response rate was 86.5%, and it was high across all subgroups.

“The response rates we have observed in patients with relapsed or refractory Hodgkin lymphoma in the phase I trial of ADCT-301 are very encouraging, as these patients have been heavily pretreated with a median of five prior therapies, including stem cell transplantation and highly active agents like brentuximab vedotin and checkpoint inhibitors,” Graham P. Collins, MB, BS, DPhil, consultant and lymphoma lead, Oxford University Hospitals, said in a statement. “The data support further evaluation of ADCT-301 in a pivotal Phase II trial in relapsed or refractory Hodgkin lymphoma.”