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
AstraZeneca launches Phase III THARROS trial for BREZTRI in COPD to assess cardiopulmonary outcomes
Merck finalises acquisition of Harpoon Therapeutics Inc
Pfizer reveals strong efficacy data for ABRYSVO in older adults against RSV
Nuvalent's NVL-520 receives FDA breakthrough therapy designation
Dassault Systèmes enhances patient care with virtual twin experience at Paris hospital
Pulmonx initiates CONVERT II trial for AeriSeal System in COPD treatment
Priority Review of Dupixent underway by FDA for COPD treatment
AstraZeneca boosts vaccine portfolio with acquisition of Icosavax
AstraZeneca reports positive resultsfor Tagrisso in Stage III lung cancer trial
AstraZeneca announces US acceptance of BLA for datopotamab deruxtecan to treat lung cancer
Erasca agrees clinical trial deal with Novartis to study naporafenib in combination with trametinib
FDA accepts Bristol Myers Squibb's Augtyro application for Priority Review