Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) shares were halved on Thursday after the firm provided an update on its midstage cancer study. The company also gave some updates on its late-stage programs with the U.S. Food and Drug Administration (FDA) as well.
Spectrum reported that its Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer patients with EGFR exon 20 insertion mutations was not met in Cohort 1.
The trial’s Cohort 1 enrolled 115 patients who received poziotinib. The intent-to-treat analysis showed that 17 patients had a response and 62 patients had stable disease, for a 68.7% disease control rate.
The confirmed objective response rate was 14.8%. The median duration of response was 7.4 months. The safety profile was in line with other second-generation EGFR tyrosine kinase inhibitors.
Joe Turgeon, president and CEO of Spectrum Pharma, commented:
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.
Separately, the company also announced that the Biologics License Application for Rolontis (eflapegrastim) was accepted for review by the FDA and set a Prescription Drug User Fee Act date of October 24, 2020.
Shares of Spectrum Pharma were last seen down 54% at $4.03, in a 52-week range of $3.61 to $12.15. The consensus price target is $23.20.