Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, has initiated 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.
“I am excited to be the lead investigator for this important study, and about the potency and safety of SPI-2012 as demonstrated in phase II,” 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. “The LAPSCOVERY technology confers long-acting properties and increased bone marrow uptake through decreased renal and vascular clearance, as well as Fc-mediated transport of G-CSF. We look forward to a successfully conducted phase III trial of SPI-2012. I believe this novel biologic drug, if approved, would be a very valuable addition to our supportive care armamentarium for cancer patients receiving myelosuppressive cytotoxic chemotherapy.”
“SPI-2012 is a third generation agent for the treatment of neutropenia that has shown promising results in phase II trials,” said, Jeffrey L. Vacirca, M.D., FACP CEO, managing partner & chief of clinical research at North Shore Hematology/Oncology Associates and Vice-President, Community Oncology Alliance. “In the phase II trial, the duration of severe neutropenia was equivalent to pegfilgrastim at the medium dose and superior at the high dose. No new or significant dose-related toxicities have been observed in over 230 patients who have been treated with SPI-2012, and the incidence of adverse events has been similar to pegfilgrastim.”
In accordance with the SPA, this registrational, phase III 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 3.6mg of GCSF, which was selected based on the robust pharmacological and pharmacodynamic data from phase II.
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.