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Positive phase I results for pegfilgrastim biosimilar Posted 16/10/2015

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 1 October 2015 that results from a phase I study of its pegfilgrastim biosimilar (CHS‑1701) had met its primary endpoint.

The aims of the phase I trial were to study the pharmacokinetics (PK), pharmacodynamics (PD) and safety (including immunogenicity) of Coherus’s biosimilar (CHS-1701) compared to Amgen’s neutropenia* treatment Neulasta (pegfilgrastim). The trial is a randomized, double-blind, single-dose, 2-period crossover study in healthy patients. All patients received a single 6 mg subcutaneous injection of CHS-1701 and a single 6 mg subcutaneous injection of Neulasta.

A total of 116 healthy volunteer subjects were randomized to one of two treatment sequences; Neulasta (Period 1) then CHS-1701 (Period 2) or CHS-1701 (Period 1) then Neulasta (Period 2).

The study met its primary PD endpoint of absolute neutrophil count (ANC). In terms of PK parameters, the study also met bioequivalence for Cmax. The area under the curve (AUC) portion of the PK results are still under review.

All four treatment groups performed as expected and the study met both PD endpoint measures of absolute neutrophil count (ANCmax and ANC AUC). For PK, three of the four treatment groups, which included both of the CHS-1701 treatment groups and the Period 2 Neulasta group, performed as expected. The PK maximum concentration (Cmax) endpoint of the study met bioequivalence. A low, anomalous PK profile in the Period 1 Neulasta group resulted in not meeting bioequivalence in the area-under-the-curve (AUC) endpoints (AUC0-to-288, AUC0-to-Inf, AUCLast). Coherus, in collaboration with the US Food and Drug Administration, is investigating the root cause of this anomalous result.

In terms of any drug-related adverse events, the safety profile was equivalent between the CHS-1701 and Neulasta treatment arms, and no neutralizing antibodies were identified in either treatment cohort.

Coherus is also carrying out another phase I trial with its biosimilar pegfilgrastim candidate (CHS-1701) to assess immunogenicity in healthy patients, according to ClinicalTrials.gov.

Given these overall positive results, Coherus believes that it remains on track for its planned filing for approval of its pegfilgrstim biosimilar in the first quarter of 2016.

*Neutropenia is a lack of certain white blood cells caused by cancer chemotherapy

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Source: ClinicalTrials.gov

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