MYL-1401H, a biosimilar product, is equivalent in efficacy to its reference product, pegfilgrastim, for the prevention of chemotherapy-induced neutropenia among patients with breast cancer, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
For the multicenter, double-blind, phase 3 trial (EudraCT Number: 2014-002324-27), investigators enrolled 194 patients with newly diagnosed stage II or III breast cancer eligible to receive a chemotherapy regimen of docetaxel, doxorubicin, and cyclophosphamide every 3 weeks for 6 cycles.
Participants were randomly assigned 2:1 to receive either the biosimilar or the reference product on day 2 of each cycle.
The average duration of severe neutropenia during cycle 1 was 1.2 ± 0.93 days with MYL-1401H compared with 1.2 ± 1.10 with pegfilgrastim, suggesting that the biosimilar product is equivalent to pegfilgrastim.
The rates of grade 3 to 4 neutropenia, time to absolute neutrophil count nadir, and duration of post-nadir recovery were similar between treatment arms. The safety profiles of both agents were similar and toxicities were manageable. The most common treatment-related adverse event in both groups was bone pain.
The European Medicines Agency has accepted a regulatory submission for MYL-1401H for review, though it is unclear if developers Mylan and Biocon will submit a Therapeutic Biologic Application for the biosimilar product to the U.S. Food and Drug Administration.
- Waller CF, Blakeley C, Pennella E, et al. Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta in the prophylaxis of chemotherapy-induced neutropenia. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.