A second-line chemo-immunotherapy regimen was a “highly effective” bridge to transplant in patients with relapsed or refractory classical Hodgkin lymphoma (cHL), researchers reported in the Journal of Clinical Oncology.
The researchers conducted a single-arm, phase 2 study (ClinicalTrials.gov Identifier: NCT03618550) to evaluate the safety and efficacy of the regimen — pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin (pembro-GVD) — as second-line therapy in patients with relapsed/refractory cHL.
The study enrolled 39 patients, of whom 41% had primary refractory disease and 38% had relapsed within the first year of frontline therapy. The patients received 2 cycles (n=31) or 4 cycles (n=8) of pembro-GVD.
Patients who achieved a complete response after completing the regimen could proceed to consolidation with high-dose therapy and autologous hematopoietic cell transplant (HDT/AHCT).
Of the 39 patients enrolled, 38 were evaluable for response to pembro-GVD. The overall response rate was 100%, and the complete response rate was 95%.
There were 36 patients (95%) who went on to receive HDT/AHCT, 2 of whom received involved-site radiation before HDT.
After HDT/AHCT, 12 patients received brentuximab vedotin maintenance, and 1 received brentuximab vedotin plus nivolumab.
At a median follow-up of 13.5 months, all 36 transplanted patients were alive and in remission.
All 39 patients were evaluable for adverse events (AEs) related to pembro-GVD. Most AEs were grade 1 or 2 in nature. Grade 3 AEs included transaminitis (n=4), neutropenia (n=4), mucositis (n=2), thyroiditis (n=1), and rash (n=1).
“Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT,” the study authors concluded.
Disclosure: This research was supported by Merck Sharp & Dohme Corp. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Moskowitz AJ, Shah G, Schöder H, et al. Phase II trial of pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin as second-line therapy for relapsed or refractory classical Hodgkin lymphoma. J Clin Oncol. Published online June 25, 2021. doi:10.1200/JCO.21.01056