Spectrum Pharma's Lung Cancer Treatment Trial Misses Main Goal; Stock Drops

(RTTNews) - Spectrum Pharmaceuticals, Inc. (SPPI) said that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer or NSCLC patients with EGFR exon 20 insertion mutations was not met in Cohort 1.

In Thursday pre-market trade, SPPI is trading at $5.55, down $3.20 or 36.57 percent.

The company also announced that the Biologics License Application (BLA) for ROLONTIS was accepted for review by the U.S. Food and Drug Administration and set a Prescription Drug User Fee Act date of October 24, 2020.

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."

The company said it looks 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.