Spectrum Pharmaceuticals Provides Pipeline Update on Late Stage Programs
The ZENITH20 trial’s Cohort 1 enrolled a total of 115 patients who received 16 mg/day of poziotinib. The intent-to-treat analysis showed that 17 patients had a response (by RECIST) and 62 patients had stable disease for a 68.7% disease control rate (DCR). The confirmed objective response rate (ORR) was 14.8% (95% Confidence Interval (CI) 8.9%-22.6%). The median duration of response was 7.4 months. The safety profile was in-line with othersecond-generation EGFR tyrosine kinase inhibitors.
The ZENITH20 trial is made up of 7 independent cohorts. Cohorts 1 - 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 - 7 are exploratory studies. The futility analysis has been completed for Cohorts 2 and 3 which met their minimum threshold of responses to continue. The company expects to report results for these cohorts in 2020. Cohorts 4, 5, 6 and 7 are continuing per protocol.
“In Cohort 1, poziotinib has shown unequivocal biologic activity. Although we are disappointed by the ORR, we are highly encouraged by other measures including the disease control rate, the duration of response and the predictable safety profile,” said
The company also announced today that the
“If approved, ROLONTIS could be the first novel granulocyte colony-stimulating factor (G-CSF) available to healthcare providers in over 15 years,” said
The BLA for ROLONTIS is supported by data from two successful large pivotal Phase 3 clinical trials, ADVANCE (conducted under a SPA) and RECOVER. These trials evaluated the safety and efficacy of ROLONTIS in a total of 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both trials, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority (NI) to pegfilgrastim in the DSN across all 4 cycles of chemotherapy (all NI p<0.0001) in both trials.
Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum holds an exclusive license from
About ROLONTIS and the ADVANCE and RECOVER Clinical Trials
The ROLONTIS ADVANCE trial was 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 eflapegrastim (n=196) or pegfilgrastim (n=210). The primary endpoint was the duration of severe neutropenia (DSN) in Cycle 1 of absolute neutrophil count [ANC] <0.5×109/L, as measured by ANC. 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 early stage 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 dose of either eflapegrastim or pegfilgrastim subcutaneously. The ADVANCE trial was conducted under a special protocol assessment (SPA) with the
The RECOVER trial was 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 eflapegrastim (n=118) or pegfilgrastim (n=119). The primary endpoint was the duration of severe neutropenia (DSN) in Cycle 1 of absolute neutrophil count [ANC] <0.5×109/L, as measured by ANC. Secondary endpoints included the DSN in Cycles 2, 3 and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. Patients with early stage 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 dose of either eflapegrastim or pegfilgrastim subcutaneously.
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 treatment potential of poziotinib for NSCLC patients with EGFR and HER2 exon 20 mutations, as well as for other solid tumor indications and combination therapy, the success and timing of Spectrum’s clinical trials generally, including the results of subgroups and Spectrum’s ability to meet secondary endpoints in Cohort 1 and the results from Cohorts 2 through 7 of the ZENITH20 study, the likelihood of success and timing of the Company’s BLA submission to the
Spectrum Pharmaceuticals, Inc.
Vice President, Strategic Planning & Investor Relations