Pembrolizumab Plus ICE: ‘Acceptable’ Salvage for Relapsed/Refractory Hodgkin Lymphoma

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Pembrolizumab in combination with ifosfamide, carboplatin, and etoposide (ICE) produced a high complete metabolic response (CMR) rate in patients with relapsed/refractory classical Hodgkin lymphoma (cHL), according to results of a phase 2 study.

CMR prior to autologous hematopoietic stem cell transplant (auto-HSCT) predicts progression-free survival (PFS) and overall survival (OS), explained Locke J. Bryan, MD, of Augusta University in Georgia, who presented these results at the 2021 American Society of Hematology (ASH) Annual Meeting.

“Our hypothesis was that the combination of pembro plus ICE chemotherapy would be a safe and effective regimen to improve the complete metabolic response rate prior to autologous stem cell transplant,” Dr Bryan said.


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The single-arm phase 2 trial (ClinicalTrials.gov Identifier: NCT03077828) enrolled 43 patients with relapsed/refractory cHL who were eligible for auto-HSCT. The primary endpoint was the rate of CMR on PET/CT, defined as a Deauville score of 3 or lower.

Patients received pembrolizumab at 200 mg on day 1 with standard ICE. After two 21-day cycles, patients underwent stem cell mobilization and collection. They then received pembrolizumab monotherapy (200 mg) and underwent PET/CT.

Patients with a Deauville score of 3 or lower went on to auto-HSCT, in some cases preceded by an additional cycle of pembrolizumab-ICE. Patients with higher Deauville scores went off study.

A total of 37 patients were evaluable for efficacy. The patients’ median age was 37 years (range, 19-70 years), 68% were women, and 39% had primary refractory disease.

The CMR rate after 2 cycles of pembrolizumab-ICE was 86.5%. In all, 45% of patients had a Deauville score of 1, 27% had a score of 2, 8% had a score of 3, 14% had a score of 4, and 5% had a score of 5.

Five patients went on to receive an additional cycle of pembrolizumab-ICE, and 35 went on to auto-HSCT.

At 2 years, the PFS rate was 88.2%, and the OS rate was 95.1%.

A total of 42 patients were included in the safety analysis. The most common grade 3-4 hematologic adverse events (AEs) were thrombocytopenia (93%), anemia (76%), and febrile neutropenia (29%). Common grade 3-4 nonhematologic AEs included hypokalemia (36%), hypophosphatemia (26%), and oral mucositis (24%).

There were 2 grade 5 AEs. One patient died of cardiac arrest during stem cell collection, but this was not considered related to pembrolizumab.

The other patient had acute respiratory distress syndrome after auto-HSCT, attributed to engraftment syndrome. This death was considered possibly related to pembrolizumab.

“Pembrolizumab plus ICE chemotherapy is both a tolerable and efficacious regimen,” Dr Bryan said. “We found a high complete metabolic response rate, as assessed by PET/CT. This is an acceptable salvage regimen for patients fit for autologous transplant.”

Disclosures: This research was supported by Merck. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.

Reference

Bryan LJ, Casulo C, Allen P, et al. Pembrolizumab (PEM) added to ICE chemotherapy results in high complete metabolic response rates in relapsed/refractory classic Hodgkin lymphoma (cHL): A multi-institutional phase II trial. Presented at ASH 2021; December 11-14, 2021. Abstract 229.



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