Positive phase III results for adalimumab and trastuzumab biosimilars

Biosimilars/Research | Posted 13/01/2017 post-comment0 Post your comment

Phase III studies of an adalimumab biosimilar from Momenta Pharmaceuticals (Momenta) and a trastuzumab biosimilar from Pfizer have, according to the companies, shown that the biosimilars are ‘equivalent’ compared to their respective originator biologicals.

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Pharma giant Pfizer announced on 30 November 2016 that its pivotal phase III REFLECTIONS B3271002 study of its trastuzumab biosimilar (PF-05280014) versus Herceptin (trastuzumab) had met its primary endpoint.

The phase III trial evaluated the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus Herceptin (trastuzumab) with paclitaxel in female patients with HER2+, metastatic breast cancer in the first-line treatment setting. The trial, which planned to enrol 690 adult females and was started back in 2014 [1], tested the hypothesis that the efficacy objective response rate (ORR) of PF-05280014 is similar to Herceptin.

The trial, according to Pfizer, ‘demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-05280014 versus Herceptin, taken in combination with paclitaxel, in first-line patients with HER2+ metastatic breast cancer’. ORR is defined as the proportion of patients with tumour size reduction of a predefined amount and for a minimum period of time.

US-based biotechnology firm Momenta announced on 29 November 2016 that the confirmatory phase III clinical study of its adalimumab biosimilar candidate (M923) developed in collaboration with Baxalta (now part of Shire) had met its primary endpoint.

The phase III trial evaluated the efficacy, safety, and immunogenicity of a M923 compared to Humira (adalimumab) in patients with moderate to severe chronic plaque-type psoriasis. The trial planned to enrol 827 adults and is expected to complete in May 2017.

The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was ‘equivalent’ between M923 and Humira, according to Momenta. The company also said that ‘the estimated difference in responders was well within the pre-specified confidence interval, confirming equivalence’. Finally Momenta added that ‘equivalence was also achieved in all secondary efficacy endpoints, including the achievement of PASI-50, PASI-90, proportion achieving clear or near-clear skin, and change from baseline in absolute PASI score. Adverse events were comparable in terms of type, frequency, and severity, and were consistent with the published safety data for Humira’.

Editor’s comment
It should be noted that data of the studies presented in this article were published as press releases. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

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1. GaBI Online - Generics and Biosimilars Initiative. Pfizer to start phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-start-phase-III-biosimilar-trastuzumab-trial

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Source: ClinicalTrials.org, Pfizer, Momenta

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