Spectrum Pharmaceuticals, a U.S.-based biotechnology company, announced Monday that its phase 3 clinical trials result for Rolontis has met its primary endpoint of non-inferiority in the duration of severe neutropenia in comparison to Peg-Filgrastim.
Rolontis is a biological drug with long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology.
The phase 3 clinical trial, named “Advance,” prescribed Rolontis to 406 patients with early-stage breast cancer. The incidence of adverse events in this study was similar between the Rolontis and its compared drug. The company also announced that “Recover,” the second phase 3 study, has completed enrollment.
"The Advance study affirms the efficacy and safety of Rolontis that was observed in phase 2 clinical studies," said Lee S. Schwartzberg, head of the trial and a professor at University of Tennessee Health Science Center’s hematology and oncology department. "If approved, this drug would be a welcome addition to supportive care treatment options for cancer patients receiving myelosuppressive cytotoxic chemotherapy.”
Spectrum was also enthusiastic about the trial results.
"The positive top-line data from our phase 3 study is an important milestone for Spectrum as we continue to move our company forward,” Spectrum’s President and CEO Joe Turgeon said. "Also, the completion of enrollment of our second phase 3 clinical trials keeps us on track to apply for its domestic marketing in the fourth quarter of 2018.”
Rolontis has the potential to be an important alternative for physicians and patients in this multibillion-dollar market, Turgeon added.
In response to Spectrum’s success in its first phase 3 clinical trials, Hanmi released a statement on Tuesday expressing its expectation.
“Rolontis is a meaningful new drug as it is the first drug that is close to commercialization using Hanmi’s Lapscovery,” Hanmi CEO Kwon Se-chang said. “With the successful development of Rolontis, the company will do its best to help patients suffering from diseases.”
In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis except for Korea, China and Japan.
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