Therapy Areas: Respiratory
Spectrum Pharmaceuticals Phase 2 Trial Fails to Meet Primary Endpoint
31 December 2019 - - US-based biopharmaceutical company Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) has 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 said.

The company also announced that the Biologics License Application for Rolontis (eflapegrastim) was accepted for review by the US Food and Drug Administration 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.

The confirmed objective response rate was 14.8% (95% Confidence Interval 8.9%-22.6%). The median duration of response was 7.4 months.

The safety profile was in-line with other second-generation EGFR tyrosine kinase inhibitors.

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.

The company also announced TODAY that the FDA has accepted for review the BLA for Rolontis for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the Rolontis BLA has been set for October 24, 2020.

The BLA for Rolontis is supported by data from two successful large pivotal Phase 3 clinical trials, ADVANCE (conducted under a SPA) and RECOVER.

These trials evaluated the safety and efficacy of Rolontis in a total of 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy.

In both trials, Rolontis demonstrated the pre-specified hypothesis of non-inferiority in duration of severe neutropenia and a similar safety profile to pegfilgrastim.

Rolontis also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles of chemotherapy (all NI p
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