FDA lifts partial hold on the phase II trial of camidanlumab tesirine in patients with R/R Hodgkin lymphoma

On July 6, 2020, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the phase II clinical trial of camidanlumab tesirine in patients with relapsed or refractory (R/R) Hodgkin lymphoma (HL).

Camidanlumab tesirine is an anti-CD25 antibody-drug conjugate which is being evaluated for patients with R/R classical HL (cHL). At the 15th International Conference on Malignant Lymphoma (ICML), the lymphoma hub spoke to Graham Collins, Oxford University Hospitals NHS Foundation Trust, Oxford, UK, who reported the results of the phase I trial (watch the video here).

The pivotal phase II (NCT04052997) multi-center, open-label, single-arm clinical trial is evaluating the safety and efficacy of camidanlumab tesirine in patients with R/R cHL. Patients with R/R cHL who failed three previous lines of therapy including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g. nivolumab or pembrolizumab) were eligible for the study. Patients already enrolled in the trial continued to be treated during the partial clinical hold, and now that the hold has been lifted, additional patient enrolment can resume.

The study is expected to support the submission of a Biologics License Application to the FDA.