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Spectrum Pharma phase 3 ADVANCE study of Rolontis meets primary endpoint

Henderson, Nevada
Wednesday, February 7, 2018, 18:00 Hrs  [IST]

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced that the first phase 3 study of Rolontis, ADVANCE, has met its primary endpoint of non-inferiority in duration of severe neutropenia in comparison to pegfilgrastim. This study evaluated the safety and efficacy of Rolontis in the management of chemotherapy-induced neutropenia in 406 patients with early-stage breast cancer. The incidence of adverse events in this study was similar between the Rolontis and the pegfilgrastim arms. 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 the phase 2 study," said Lee S. Schwartzberg, M.D., FACP Professor of Medicine and Division chief, Hematology Oncology, The University of Tennessee Health Science Center, and Executive Director, UT/West Cancer Center. “If approved, this drug would be a welcome addition to supportive care treatment options for cancer patients receiving myelosuppressive cytotoxic chemotherapy.”

“The positive top line data from our phase 3 study is an important milestone for Spectrum as we continue to move our company forward,” said Joe Turgeon, president and chief executive officer of Spectrum Pharmaceuticals. “Also, the completion of enrollment of our second phase 3, the RECOVER study, keeps us on track to file a BLA in the fourth quarter of 2018. Rolontis has the potential to be an important alternative for physicians and patients within this multibillion dollar market.”

In accordance with the FDA Special Protocol Assessment, phase 3 ADVANCE study was a multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who receive docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized 1:1 to treatment with Rolontis or pegfilgrastim. The primary study endpoint was the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] <0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle.

In January 2012, Spectrum entered into a licensing agreement with Hanmi Pharmaceuticals, gaining global rights for Rolontis (except Korea, China, and Japan).


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