Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

Spectrum Pharmaceuticals Provides Pipeline Update on Late Stage Programs

Posted by fidest press agency su mercoledì, 1 gennaio 2020

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today reported that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations was not met in Cohort 1. The company also announced that the Biologics License Application (BLA) for ROLONTIS®(eflapegrastim) was accepted for review by the U.S. Food and Drug Administration (FDA) and set a Prescription Drug User Fee Act (PDUFA) date of October 24, 2020.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.Joe Turgeon, President and CEO of Spectrum Pharmaceuticals said, “While the response rate of Cohort 1 in this trial was lower than we expected, the positive signals observed for this cohort provide support for the continued clinical evaluation of poziotinib in this patient population with significant unmet medical need. We look forward to providing read outs from Cohorts 2 and 3 in 2020, and plan to provide an update on the overall program strategy during the first quarter of 2020 after a full evaluation of the data from Cohort 1 is completed.”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.

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