|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
Penpulimab led to an overall response rate (ORR) of 89.4% among patients with relapsed/refractory classic Hodgkin lymphoma (R/R cHL), with a low rate of serious adverse events (SAEs), according to the results of a study presented at the 2021 American Society of Clinical Oncology Annual Meeting.
In the multicenter, single-arm, open-label study (ClinicalTrials.gov Identifier: NCT03722147), patients with R/R cHL received penpulimab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody that blocks programmed cell death protein 1 (PD-1) binding to programmed death-ligand 1 (PD-L1), 200 mg every 2 weeks until progression or unacceptable toxicity. All participants had previous autologous stem cell transplant or at least 2 lines of prior chemotherapy.
ORR was the primary endpoint, which was assessed by an independent review committee (IRC), using the Lugano 2014 criteria. Complete response (CR) rate, disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), safety, and tolerability were key secondary endpoints.
Among 94 patients enrolled (median age, 32.0 years [range, 31-71 years]; 59.6% men; 26.6% Eastern Cooperative Oncology Group score 1), 56 remained on treatment. Of these, 4 completed 24 months of treatment, and 25 discontinued treatment (17 due to disease progression, and 3 due to adverse events) as of November 8, 2020.
The IRC-assessed ORR among the 85 patients who were evaluated for efficacy was 89.4% (95% CI, 80.8-95.0) after a median follow-up of 15.8 months. CR was achieved among 40 (47.1%) patients. The median DOR was not achieved, with a range of 1.7 months to longer than 24.5 months. The median PFS also was not reached, with a 12-month rate of 72.1% (95% CI, 60.5-80.8).
Treatment-related adverse events (TRAEs), which included unlikely related events, occurred in 97.9% of the study participants (grade ≥3 in 26.6%; treatment discontinuation in 5.3%), and treatment-related serious AEs (SAEs) were observed in 10.6% of the cohort. Hypothyroidism (31.9%), upper respiratory tract infection (25.5%), fever (24.5%), and alanine aminotransferase elevations (23.4%) were the most common TRAEs.
Grade 3 or worse TRAEs occurring in 2 or more patients were decreased platelet count (3.2%), hyperlipemia (3.2%), rash (3.2%), and decreased neutrophil count (2.1%). Grade 3 immune-related AEs (irAEs) were reported in 4.3% of patients: IgA nephropathy, pneumonitis, rash, and psoriasis each occurred in 1 patient, and no grade 4 or grade 5 irAEs were reported.
The study authors concluded that “[p]enpulimab was shown to be highly active in achieving a CR rate of 47.1% in patients with R/R cHL.”
Disclosure: This clinical trial was supported by Akeso Biopharma Inc. Please see the original reference for a full list of authors’ disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Song Y, Zhou K, Jin C, et al. A phase II study of penpulimab, an anti-PD-1 antibody, in patients with relapsed or refractory classic Hodgkin lymphoma (cHL). J Clin Oncol. 2021;39:(suppl 15; abstr 7529). doi:10.1200/JCO.2021.39.15_suppl.7529