Date: 2018-02-05
Type of
information: Interim results
phase: 3
Announcement: interim results
Company: Spectrum Pharmaceuticals (USA - NV)
Product: Rolontis™ (eflapegrastim)
Action
mechanism:
- protein. Eflapegrastim is a long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi Pharmaceutical Co., Ltd. proprietary platform technology, Lapscovery™. It binds to the G-CSF receptor expressed on granulocyte progenitors and stimulates their proliferation and subsequent maturation to functionally active neutrophils.
- In January 2012, Spectrum entered into a licensing agreement with Hanmi Pharmaceuticals, gaining global rights for Rolontis™ (except Korea, China, and Japan).
Disease: chemotherapy-induced neutropenia in patients with breast cancer.
Therapeutic
area: Cancer - Oncology - Hematological diseases
Country:
Trial
details:
- In accordance with the SPA, this registrational, Phase 3 or ADVANCE study (RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide) is a multicenter, randomized, active controlled trial that will enroll 580 newly diagnosed early-stage breast cancer patients, who will receive adjuvant or neoadjuvant chemotherapy every 21 days. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to shrink the tumor and potentially allow for breast-conserving surgery. SPI-2012 will be administered subcutaneously as a fixed dose equivalent to 3.6 mg of GCSF, which was selected based on the robust pharmacological and pharmacodynamic data from Phase 2. The primary study endpoint is 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. Secondary endpoints include the incidence of neutropenic complications, incidence of Febrile Neutropenia, Relative Dose Intensity, and safety.
Latest
news:
- • On February 5, 2018, Spectrum Pharmaceuticals 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. Spectrum Pharmaceuticals intends to file a BLA in the fourth quarter of 2018.
- • On August 1, 2017, Spectrum Pharmaceuticals announced that the company has completed enrollment with 405 patients randomized in the ROLONTIS Phase 3 ADVANCE pivotal study under a Special Protocol Assessment (SPA) with the FDA. The study is evaluating the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. Spectrum plans to announce topline data early next year and expects to file a BLA in 2018.
- Spectrum is conducting a second Phase 3 study, RECOVER, which is a multicenter, randomized, active-controlled study similar in design to the ADVANCE study that is currently enrolling in the U.S. and Europe. This study will enroll approximately 218 early-stage breast cancer patients, who will receive adjuvant or neoadjuvant TC (docetaxel and cyclophosphamide) chemotherapy every 21 days for up to 4 cycles. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term, disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to help shrink the tumor and potentially allow for breast-conserving surgery. The primary study endpoint is 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. Secondary endpoints include the incidence of neutropenic complications, incidence of febrile neutropenia, relative dose intensity, and safety.
- • On January 29, 2016, Spectrum Pharmaceuticals announced initiation of the planned registrational trial for SPI-2012 (eflapegrastim), its novel, long-acting G-CSF. This trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, and will serve as the basis for the Biologics License Application (BLA) filing.
Is
general: Yes
