Geptanolimab shows efficacy in relapsed/refractory peripheral T-cell lymphoma
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Geptanolimab, an anti-PD-1 antibody, appeared effective and safe for patients with relapsed or refractory peripheral T-cell lymphoma, according to results of a phase 2 multicenter trial presented at the virtual American Association for Cancer Research Annual Meeting.
The agent also had an acceptable safety profile.
“Geptanolimab can be a new treatment option for relapsed or refractory peripheral T-cell lymphoma, especially for those with a PD-L1 combined positive score of 50 or higher,” Yuan-Kai Shi, MD, researcher at the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital in Beijing, said during a presentation.
Shi and colleagues assessed the safety and efficacy of 3 mg/kg IV geptanolimab (GB226, Genor Biopharma Co. Ltd.) once every 2 weeks until disease progression or intolerable toxicity among 102 patients (median age, 52.5 years; 70% men) with relapsed or refractory peripheral T-cell lymphoma recruited across 32 sites in China.
Objective response rate served as the primary endpoint. Duration of response, time to response, disease control rate, PFS, OS, safety and immunogenicity served as secondary endpoints.
Researchers assessed treatment response according to Lugano 2014 criteria by independent review. Follow-up occurred every 6 weeks during the first year and every 12 weeks thereafter.
Median follow-up was 3.98 months (range, 0.3-15.63).
Results showed an ORR of 36.3% (95% CI, 26.9-46.3). Eleven patients (10.8%) achieved complete response and 26 (25.5%) achieved partial response. Disease control rate was 55.9% (95% CI, 45.7-65.7).
Median duration of response was 6.83 months (95% CI, 5.13 to not reached), median time to response was 4.04 months (95% CI, 1.48-8.52) and median PFS was 2.69 months (95% CI, 1.74-4.21). Median OS had not been reached at the time of data cutoff.
Results of subgroup analyses showed similar efficacy across age, gender, clinical stage and previous treatment lines.
Researchers observed an ORR of 33.3% with geptanolimab after treatment failure with the oral histone deacetylase inhibitor chidamide (Epidaza, Chipscreen Bioscience).
In addition, ORR was 58.3% among patients with anaplastic lymphoma kinase-negative anaplastic large cell lymphoma, 42.9% among those with anaplastic lymphoma kinase-positive anaplastic large cell lymphoma, 40.9% among those with extranodal NK/T-cell lymphoma (ENKTL), 28.2% among those with nasal-type ENKTL and 31.8% among those with peripheral T-cell lymphoma not otherwise specified and other types.
The most common treatment-related adverse events included white blood cell count reduction (18.6%), fever (14.7%) and anemia (13.7%). Moreover, 35.3% of patients experienced immune-related adverse events, including 10.8% with grade 3 or higher immune-related adverse events. – by Jennifer Southall
Reference:
Shi YK, et al. Abstract CT041. Presented at: AACR Annual Meeting; April 27-28, 2020 (virtual meeting).
Disclosures: Shi reports no relevant financial disclosures. Please see the abstract for all other researchers’ relevant financial disclosures.
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