Hanmi’s 1st biologic drug Rolontis closer to FDA license review

2018.12.07 13:44:36 | 2018.12.07 14:13:02

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Rolontis, a novel, long-acting neutropenia drug developed by South Korea’s Hanmi Pharmaceutical Co., is one step closer to Biologics License Application (BLA) filing to the U.S. Food and Drug Administration after another late-stage clinical study data confirmed the drug’s efficacy and safety profile.

Hanmi Pharm Friday said its U.S. partner Spectrum Pharmaceuticals presented data from the Phase 3 RECOVER clinical study at the 2018 San Antonio Breast Cancer Symposium (SABCS) on Thursday, which confirmed non-inferiority of Rolontis (eflapegrastim) to Amgen`s Neulasta (pegfilgrastim) in reducing the duration of severe neutropenia (DSN) in breast cancer patients treated with chemotherapy.

Spectrum is positioning Rolontis as an alternative to pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) used to help reduce the neutropenic effects of chemotherapy.

The data showed that in Cycle 1, the mean DSN±SD (standard deviation) was 0.31±0.688 days for Rolontis and 0.39±0.949 days for pegfilgrastim, demonstrating non-inferiority. The non-inferiority of Rolontis for DSN was maintained across all four treatment cycles, according to the data.

Incidence of severe neutropenia was 20 percent versus 24 percent in the eflapegrastim and pegfilgrastim arms respectively, with a relative risk reduction of 14 percent in favor of eflapegrastim. There were no statistically significant differences on secondary endpoints such as time to absolute neutrophil count (ANC) recovery, depth of ANC nadir, and incidence of febrile neutropenia between treatment arms across all cycles.

“The RECOVER study is the second Phase 3 study to confirm non-inferiority data and comparable safety profile between Rolontis and the current standard of care,” said Joe Turgeon, chief executive officer of Spectrum Pharmaceuticals. “Data from both studies, which enrolled 643 patients combined, will be used to support the BLA filing which is expected to be submitted by the end of the year.”

Spectrum picked up Rolontis from Hanmi Pharm in 2012, obtaining worldwide rights outside Korea, China and Japan. Data from the first Phase 3 study of the drug were presented at American Society of Clinical Oncology and Multinational Association of Supportive Care in Cancer (MASCC) conferences.

By Kim Hye-soon and Minu Kim

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