Spectrum Pharmaceuticals Announces Integrated Results from Two Phase 3 ROLONTIS® (eflapegrastim) Trials Being Presented at the ASCO Annual Meeting
- Integrated efficacy and safety results in 643 patients were consistent with individual trial results (ADVANCE and RECOVER)
- The integrated data demonstrated that eflapegrastim provided an absolute risk reduction of severe neutropenia of 6.5% compared to pegfilgrastim in Cycle 1
The analysis found that integrated efficacy and safety data from the two
identically designed Phase 3 trials – ADVANCE and RECOVER – were
consistent with results from the individual trials, demonstrating that
ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration
of severe neutropenia (DSN) in all four cycles of treatment. The summary
was presented today during a poster session at the American Society of
Clinical Oncology 2019 Annual Meeting in
“These integrated analyses confirm non-inferiority in efficacy and a
similar safety profile between eflapegrastim and pegfilgrastim across
all cycles of treatment, including a 95 percent confidence interval of
the difference in the DSN below zero in favor of ROLONTIS in the first
cycle of treatment,” said Lee Schwartzberg, M.D., FACP, lead
investigator, executive director,
Integrated data derived from the two Phase 3 clinical trials, demonstrated that in Cycle 1, the mean DSN±SD was 0.24±0.581 days for ROLONTIS (n=314) and 0.36±0.789 days for pegfilgrastim (n=329), demonstrating non-inferiority (p<0.0001). The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles (all p<0.0001). The ROLONTIS arm had an absolute risk reduction of severe neutropenia of 6.5% (95% CI: 0.2%, 13%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was defined as the difference in the percentage of patients who experienced severe neutropenia (ROLONTIS 17.5%; pegfilgrastim 24%). Febrile neutropenia (3.2% vs. 3%; p=NS) and neutropenic complications (5.7% vs. 5.8%; p=NS) were similar between the ROLONTIS and pegfilgrastim arms. Integrated safety data presented today also showed that the adverse events in general, regardless of causality, were not significantly different between the two treatment arms.
“Neutropenia remains a significant complication for people undergoing
myelosuppressive chemotherapy, potentially causing hospitalizations and
delays in much needed cancer treatment,” said
About ADVANCE
The ADVANCE trial is a Phase 3, multicenter, randomized, active-controlled, open label trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized in a 1:1 ratio to receive ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary trial 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 (3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio.
About RECOVER
The RECOVER trial is a Phase 3, multicenter, randomized, active-controlled, open label trial 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 ROLONTIS (n=118) or pegfilgrastim (n=119). The primary trial endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×10^9/L), based on central laboratory assessment of ANC over a 21-day cycle. There were a total of four cycles evaluated in this trial. 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 (3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio.
About
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals, and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future.
Notice Regarding Forward-Looking Statements - Certain statements in
this press release may constitute “forward-looking statements” within
the meaning of the United States Private Securities Litigation Reform
Act of 1995, as amended to date. These forward-looking statements relate
to a variety of matters, including, without limitation, statements that
relate to Spectrum’s business and its future, including the Company’s
ability to advance development of its late-stage pipeline assets, the
ability of ROLONTIS to meet currently unaddressed medical needs and the
size of the potential market, the timing of the results of the clinical
trials run by Spectrum, the future potential of Spectrum’s existing drug
pipeline, the timing of the BLA filing with the
© 2019
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