Sandoz, the generics division of Novartis, announced on 7 December 2015 positive results from a phase III study of its pegfilgrastim biosimilar (LA-EP2006).
The phase III, randomized, double-blind, parallel group, multicentre study was designed to compare the efficacy and safety of candidate pegfilgrastim biosimilar (LA-EP2006) versus Neulasta (pegfilgratim) in breast cancer patients treated with myelosuppressive chemotherapy. The PROTECT 2 trial was conducted in Asia, Europe, Latin America and the US in 308 patients and was planned to have been completed in December 2013.
The primary endpoints included mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy over a period of 21 days and mean duration of severe neutropenia, defined as the number of consecutive days with Grade 4 neutropenia. Severe (Grade 4) neutropenia was defined as the number of consecutive days with an absolute neutrophil count (ANC) < 0.5 x 109/L. Secondary efficacy assessments were: time to ANC recovery, depth of ANC nadir (lowest blood cell count), incidence of febrile neutropenia, number of days of fever, infection frequency and mortality due to infection.
The phase III results for the PROTECT 2 trial of LA-EP2006 were presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition, which was held in Orlando, Florida, USA on 5–8 December 2015.
The mean ± standard deviation for the duration of severe neutropenia in Cycle 1 was 1.36 ± 1.13 days in the LA-EP2006 group versus 1.19 ± 0.98 days in the reference group (treatment difference −0.16 days; 95% confidence interval (CI): −0.40, 0.08). The authors therefore claimed that ‘LA‑EP2006 was thus both equivalent and non-inferior to reference pegfilgrastim as the 95% CI was within the defined margin of ± 1 day and the lower boundary of the 95% CI was entirely above −0.6 days’.
There were no clinically meaningful differences between the LA-EP2006 and reference groups in incidence of febrile neutropenia (7.7% vs 9.8% in Cycle 1, 10.3% vs 13.1% across all cycles), days with fever, depth of ANC nadir in Cycle 1, time to ANC recovery in Cycle 1, or frequency of infections. Treatment-emergent adverse events (TEAEs) were similar across groups and consistent with the known safety profile of pegfilgrastim.
The authors therefore concluded that the results demonstrated LA-EP2006 ‘to be both equivalent and non-inferior to the reference’ (Neulasta).
Sandoz announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration [1].
Conflict of interest
Several of the authors of the abstract [2] reported conflicts of interest, including being employees of Sandoz, having received honoraria from Sandoz, having received consultancy fees from Sandoz and other pharmaceutical companies and being the chair of Data and Safety Monitoring Board (DSMB) on trials sponsored by Sandoz. For full details of the authors’ conflicts of interest, see [2].
Editor’s comment
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
2. Blackwell K, Paltuev R, Donskih R, et al. Proposed Biosimilar Pegfilgrastim (LA-EP2006) and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients with Breast Cancer: A Randomized, Double-Blind Trial. Protect 2: Pegfilgrastim Randomized Oncology (supportive care) Trial to Evaluate Comparative Treatment Results. 57th American Society of Hematology (ASH) Annual Meeting and Exposition; 5–8 December 2015; Orlando, Florida, USA.
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