Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) announced good news for cancer patients in its midstage trial on Tuesday. The company announced that it met the prespecified primary endpoint in the Zenith20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer patients with HER2 exon 20 insertion mutations.
The second cohort of the Zenith20 clinical trial enrolled 90 patients. They all had failed at least one line of prior systemic therapy, with 60 patients (67%) having failed two or more prior therapies, including chemotherapy and immunotherapy.
The intent-to-treat analysis demonstrated a confirmed objective response rate of 27.8% with a 95% confidence interval ranging from an objective response rate of 18.9% to 38.2%.
Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.9% exceeded the prespecified lower bound of 17% in this heavily pretreated population.
The median duration of response was 5.1 months with a median follow up of 8.3 months. The disease control rate was 70% and the median progression-free survival was 5.5 months.
Note that the second cohort was designed to be a registrational study, and Spectrum Pharma is in the process of requesting a meeting with the FDA to discuss this data and plans for a New Drug Application submission.
Spectrum Pharma stock was last seen up about 15% at $3.73, in a 52-week range of $1.74 to $10.57. The consensus price target is $9.00.