Camidanlumab Tesirine for Relapsed or Refractory Classic Hodgkin Lymphoma: A Phase 2 Study

Outcomes in classic Hodgkin lymphoma (cHL) have steadily improved; however, additional therapies are needed for patients who relapse or do not respond to novel agents. Here, we report the efficacy and safety of camidanlumab tesirine (Cami), an anti-CD25 antibody-drug conjugate, in patients with relapsed/refractory cHL following brentuximab vedotin/programmed cell death protein 1 inhibitor therapies from the phase 2 ADCT-301-201 study. Eligible patients were adults with cHL who had received ≥3 prior lines of systemic therapy (or ≥2 if ineligible for hematopoietic stem cell transplant). Patients received 45 μg/kg Cami (intravenously, once every 3 weeks [Q3W]) in cycles 1 to 2, followed by 30 μg/kg IV Q3W for ≤1 year. The primary endpoint was overall response rate (ORR) per 2014 Lugano Classification. Secondary endpoints included complete response rate (CRR), progression-free survival (PFS), and overall survival (OS). In total, 117 patients were enrolled with a median age of 37.0 (range, 19, 87) years. The ORR was 70.1% (95% CI, 60.9, 78.2) with a CRR of 33.3% (24.9, 42.6). The median PFS was 9.13 (95% CI, 5.3, 15.0) months; median OS was not reached. Thirty-three (28.2%) patients discontinued treatment because of treatment-emergent adverse events; the most common reasons were skin and subcutaneous tissue disorders (10 [8.5%] patients), infections and infestations (5 [4.3%]), and nervous systems disorders (5 [4.3%]). Guillain-Barré- or polyradiculopathy-type events occurred in 8 (6.8%) patients. Cami was efficacious in this heavily pretreated population; however, the efficacy was overshadowed by substantial issues with the safety profile. NCT04052997.