Spectrum Pharmaceuticals Presents ADVANCE Phase 3 ROLONTIS® (eflapegrastim) Data at MASCC 2018 and Announces the Phase 3 RECOVER Study Met the Primary Endpoint
- ADVANCE, first Phase 3 study, met the non-inferiority of ROLONTIS to pegfilgrastim endpoint in the Duration of Severe Neutropenia (DSN) across all 4 cycles (all p<0.0001)
- ROLONTIS showed an absolute risk reduction of severe neutropenia of 8.5 percent compared to pegfilgrastim in Cycle 1
- No statistically significant differences in adverse events between treatment groups
- RECOVER, the second Phase 3 study, met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim
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“ROLONTIS data presented today demonstrated that adverse events,
including severe bone pain, were not statistically different from
pegfilgrastim and occurred at rates that are expected for those
undergoing chemotherapy,” said
The company also announced that the RECOVER study, the second Phase 3 ROLONTIS study, met the primary efficacy endpoint of non-inferiority in DSN between ROLONTIS and pegfilgrastim. The adverse event profile was also similar between the two treatment arms. The RECOVER study evaluated the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer (n=237).
The company previously announced in
“We are pleased that both ROLONTIS Phase 3 studies, which studied more
than 600 patients combined, demonstrated non-inferiority and similar
safety profiles to the current standard of care,” said
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The ADVANCE study is a Phase 3 multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized 1:1 to treatment with ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary study endpoint was the DSN (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 included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated on Day 1 of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio. The most common adverse events, which were observed in greater than 5 percent of patients, were similar across both treatment groups and included neutropenia, lymphopenia, anemia, leukopenia, febrile neutropenia and bone pain.
The RECOVER study is a Phase 3, randomized, open-label, active-controlled, multicenter study that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive either ROLONTIS (n=118) or pegfilgrastim (n=119). The primary study endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×109/L), based on central laboratory assessment of ANC over a 21 day cycle. There were a total of four cycles evaluated in this study. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at cycle one. Patients with stage I to stage IIIA breast cancer were treated on day one of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On day two of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg).
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
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forward-looking statements regarding future events and the future
Spectrum Pharmaceuticals, Inc.
Vice President, Strategic Planning & Investor Relations