New Biosimilar Demonstrates Equivalence and Noninferiority to Pegfilgrastim

Corbin Davis

March 2016, Vol 7, No 2 - Emerging Therapies

The investigational biosimilar (LA-EP2006) to the reference drug pegfilgrastim (Neulasta) has demonstrated similar results in patients with breast cancer who are receiving the regimen known as TAC (docetaxel, doxorubicin, and cyclophosphamide), according to data from the multicenter, randomized, double-blind PROTECT 2 trial.

C. Michael Jones, MD, FACP, the Jones Clinic, Germantown, TN, discussed the study results, which showed that the biosimilar was equivalent to peg­filgrastim in preventing severe neutropenia among patients who received neoadjuvant myelosuppressive chemotherapy.

“Biosimilar pegfilgrastim and the reference are similar, with no meaningful differences in efficacy, safety, or immunogenicity, and they are equivalent for all practical purposes in preventing severe neutropenia,” said Dr Jones. “We think that the biosimilar will facilitate access to supportive care by decreasing cost for these types of drugs and chemotherapy regimens where prophylaxis is necessary.”

PROTECT 2 is 1 of 2 pivotal clinical trials comparing LA-EP2006 with pegfilgrastim for the prevention of severe neutropenia in patients with breast cancer. Women receiving neoadjuvant TAC chemotherapy for breast cancer were randomized to receive a single 6-mg subcutaneous injection of LA-EP2006 or of pegfilgrastim on day 2 of each cycle.

Same Duration of Severe Neutropenia

Although a few patients did drop out in both study arms, the number of days patients had neutropenia was roughly the same.

“The differences are not statistically significant at this confidence level,” Dr Jones said. “LA-EP2006 and the reference are equivalent with respect to duration of severe neutropenia in cycle 1.”

Both drugs were also comparable in secondary efficacy parameters, including febrile episodes, depth of the absolute neutrophil count nadir and time to the absolute neutrophil count recovery in cycle 1, frequency of infection, and infection-related death.

Both drugs “were well tolerated, with comparable safety profiles,” said Dr Jones. “No treatment-related anti–pegfilgrastim-neutralizing antibodies were detected in either group, and in terms of treatment-related adverse events, the numbers are very similar between the groups.”

The biosimilar to pegfilgrastim could facilitate access to supportive care treatment for patients receiving myelosuppressive chemotherapy.

“Once-per-chemotherapy-cycle administration of pegfilgrastim could offer greater convenience, which may translate into better patient compliance and improved clinical outcomes compared to daily administration with filgrastim,” Dr Jones said.

Although he did not have access to specific pricing data, Dr Jones said that a 25% to 30% cost reduction can be expected, depending on Medicare reimbursement.

LA-EP2006 is pending approval by the FDA.