Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Next expecting to see 'ongoing, not recruiting' on the 400 pt Rolontis P3 sometime within the next one to three months

Ok, forget about the 1 to 3 month timeframe. Make that 12 hrs!!!

Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim), a Novel Long-Acting GCSF August 1, 2017

Spectrum Pharmaceuticals, Inc. (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today 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 Food and Drug Administration. The study is evaluating the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer.

“I am pleased to report that we have been able to complete enrollment in the ADVANCE study ahead of schedule,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “We plan to announce topline data early next year and expect to file a BLA in 2018. RECOVER, the second Phase 3 study for ROLONTIS, is a smaller study that will include sites in the U.S. and Europe, and is currently enrolling patients. RECOVER will leverage established relationships with U.S. sites from the ADVANCE study to help expedite enrollment. We believe ROLONTIS, if approved by the FDA, has the opportunity to change the growth trajectory of our Company because it targets a multi-billion dollar market and our team has a deep knowledge and understanding of the space. We are excited to be in the final stages of what could be a transformational development for the Company.”

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.

http://investor.sppirx.com/releasedetail.cfm?ReleaseID=1035260