Biosimilar Pegfilgrastim-cbqv Demonstrates Similar Clinical Efficacy to the Pegfilgrastim Reference in a Real-World Setting

A proof-of-concept study showed the feasibility of conducting comparative-effectiveness research at scale to promote value-based decision-making in oncology; it also confirmed efficacy equivalence between the biosimilar pegfilgrastim-cbqv and pegfilgrastim reference for the prophylaxis of chemotherapy-induced febrile neutropenia.

To achieve cost-savings, it is imperative that practices evaluate their utilization of both cancer-directed and supportive therapies. The Value Monitor is a tool that uses real-world data to provide statistically rigorous comparative-effectiveness research at scale. To provide proof of concept, the Value Monitor was used to compare the efficacy of the biosimilar pegfilgrastim-cbqv with pegfilgrastim reference, both of which are indicated for the prophylaxis of chemotherapy-induced febrile neutropenia in patients with breast cancer who were receiving myelosuppressive chemotherapy; these results were reported at the 2020 American Society of Clinical Oncology Virtual Scientific Program.

Using the Value Monitor, a matched cohort retrospective analysis was performed in patients with breast cancer receiving pegfilgrastim-cbqv or pegfilgrastim between January 1, 2017, and August 31, 2019. Patients treated with pegfilgrastim-cbqv were matched to those treated with pegfilgrastim by age (within 5 years), gender, Oncology Care Model participation status, and date of treatment (within 90 days). The efficacy end point was neutropenia rate and/or an absolute neutrophil count <1500; neutropenia was defined as the presence of a neutropenia International Classification of Diseases, 10th Edition, revision code (D70*).

A total of 496 patients were identified and included in the pegfilgrastim-cbqv cohort, and were matched to 5 pegfilgrastim patients. The incidence of neutropenia was similar between the groups: 28.6% in the pegfilgrastim-cbqv cohort and 29.1% in the pegfilgrastim cohort (McNemar’s P value, 0.82).

The biosimilar showed efficacy equivalence to its pegfilgrastim reference for the prophylaxis of chemotherapy-induced febrile neutropenia in patients with breast cancer who were receiving myelosuppressive chemotherapy. The authors attributed the higher incidence rates relative to those previously reported in the published literature to the very broad study definition of neutropenia. The proof-of-concept study also demonstrated the feasibility of performing comparative-effectiveness research at scale using the Value Monitor to inform value-based clinical decisions.

Reference
Webster J, et al. ASCO 2020. Abstract e19273.