Spectrum Pharmaceuticals (NASDAQ:SPPI) has announced additional results from its Phase 2 (ZENITH20) trial, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). Data were presented at the European Society for Medical Oncology Virtual Congress.
As reported earlier, Cohort 2 demonstrated a confirmed objective response rate (ORR) of 27.8%, with disease control rate (DCR) of 70%. Median duration of response was 5.1 months, with a median follow-up of 8.3 months and the median progression-free survival was 5.5 months.
The company says tumor reduction occurred in 67 patients (74%), with median tumor reduction of 22%. The evaluable patient analysis (n=74) demonstrated a confirmed ORR of 35.1% with a DCR of 82.4%.
On the safety front, 13 patients (14%) had treatment-related serious adverse events and 11 patients (12%) permanently discontinued due to adverse events. Serious treatment-related rash was observed in 27 patients (30%) with diarrhea in 23 patients (26%). Serious/severe stomatitis/mucosal inflammation occurred in 21 patients (23%).
Company says based on these results it has requested a meeting with the FDA to discuss the data and its plans for a marketing application submission.
Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1.
In December 2019, the primary endpoint for Cohort 1 was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. This amendment did not impact Cohorts 2 and 3 as these were fully enrolled. Top line results from Cohort 3 are expected by the end of the year.
Poziotinib is an oral epidermal growth factor receptor tyrosine kinase inhibitor that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4.
The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.
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