CORRECTING and REPLACING Spectrum Pharmaceuticals Announces Detailed Results from Phase 3 Study of ROLONTIS® (eflapegrastim) Published in an ASCO Abstract
- Primary endpoint of non-inferiority of ROLONTIS to pegfilgrastim was met
- All secondary endpoints were met
- Adverse events were similar between ROLONTIS and pegfilgrastim
- ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a propriety technology
The corrected release reads:
SPECTRUM PHARMACEUTICALS ANNOUNCES DETAILED RESULTS FROM PHASE 3 STUDY OF ROLONTIS® (EFLAPEGRASTIM) PUBLISHED IN AN ASCO ABSTRACT
- Primary endpoint of non-inferiority of ROLONTIS to pegfilgrastim was met
- All secondary endpoints were met
- Adverse events were similar between ROLONTIS and pegfilgrastim
- ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a propriety technology
“These data expand our understanding of the clinical profile of
eflapegrastim and help establish it as a possible supportive care
treatment option for the multitude of patients undergoing chemotherapy,”
said
In the ROLONTIS Phase 3 ADVANCE study (n=406), mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of ∆DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. There were no statistically significant differences in all secondary endpoints including time to absolute neutrophil count (ANC) recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. The most common adverse events, which were observed in less than 10 percent of patients, were similar across both treatment groups and were mainly hematologic, including neutropenia, lymphopenia, anemia and leukopenia.
“The ADVANCE study is a cornerstone in the ROLONTIS clinical program,
which includes one Phase 2 and two Phase 3 clinical studies involving
approximately 800 patients,” said
Spectrum is currently conducting a second Phase 3 ROLONTIS trial,
RECOVER, a multi-center study being conducted in the
About ADVANCE
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.
About
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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Source:
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com