• Friday, June 10, 2022 @ 12:00 am
  • Overall response rate of 70.1% and complete response rate of 33.3% in heavily pretreated patients; median duration of response of 13.7 months
  • Safety profile substantially consistent with prior findings
  • Preparing for potential submission of a Biologics License Application to the FDA
  • Cami data and diffuse large B-cell lymphoma posters to be presented today at the European Hematology Association 2022 Hybrid Congress

ADC Therapeutics SA (NYSE: ADCT) announced today results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory (r/r) Hodgkin lymphoma. An overall response rate (ORR) of 70.1% and a complete response (CR) rate of 33.3% was observed with a median duration of response of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin (BV) and a PD-1 blockade. The safety profile of Cami was substantially consistent with previously reported interim findings. The results will be presented today during an oral session at the European Hematology Association 2022 Hybrid Congress (EHA2022).

The Phase 2 single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy.

“Cami has demonstrated consistently favorable response rates and durability in Hodgkin lymphoma patients who have relapsed, despite using the best available treatments. These results offer hope to patients and doctors who need a new option,”  said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “With these data from our Phase 2 trial in hand, we look forward to scheduling a meeting with the FDA to discuss the potential submission of a Biologics License Application.”

Data to be presented at EHA2022 by Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital in Milan, Italy, include:

  • ORR of 70.1% and CR rate of 33.3% in patients with a median of 6 prior treatments
  • Median duration of response (DOR) was 13.7 months and median progression-free survival (PFS) was 9.1 months; patients who achieved a CR had a median DOR of 14.5 months
  • 14 patients received HSCT following treatment with Cami
  • The most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were: thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), maculopapular rash (6.8%) and lymphopenia (5.1%)
  • 8/117 patients developed Guillain-Barré syndrome/polyradiculopathy. GBS symptoms could be mitigated with careful medical intervention.

“Very few viable or sustainable treatment options are available for patients with Hodgkin lymphoma who are refractory or relapse following treatment with brentuximab vedotin and PD-1 inhibitor therapy,” said Dr. Carlo-Stella. “Results from the pivotal Phase 2 trial indicate Cami, a novel CD25-targeted ADC, has the potential to fill the need for a new treatment option for heavily pretreated patients with Hodgkin lymphoma.”