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news.Xcovery has started its Phase 3 trial of X-396 in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).
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The eXalt3 trial is an open-label, randomized study designed to evaluate the efficacy and safety of X-396, the Company’s lead ALK inhibitor drug candidate, versus crizotinib in over 400 patients with ALK+ NSCLC.
"The initiation of our Phase 3 eXalt3 trial represents an important step forward in Xcovery’s advancement of our lead candidate, X-396," said Michael Webb, Chief Executive Officer and President of Xcovery.
"The recently released data from our ongoing Phase 1/2 study of X-396 showed promising activity with durable responses noted in both treatment-naïve patients as well in patients resistant to current standard-of-care. These results, coupled with a favorable tolerability profile, support the continued development of X-396 as a potential new treatment option for patients with ALK+ NSCLC. Xcovery will now focus on actively recruiting additional patients and new clinical sites across the globe."
About the Phase 3 eXalt3 Study
The Phase 3 eXalt3 study is an open-label, randomized study that will evaluate the efficacy and safety of the ALK inhibitor X-396 compared to crizotinib in patients with ALK+ NSCLC. The primary efficacy endpoint being measured is progression-free survival (PFS) as assessed by an independent radiology review based on RECIST v. 1.1 criteria.
The study will also allow the Company to obtain additional pharmacokinetic data on X-396 in select patients and samples for exploratory biomarkers research to be compared against the clinical outcomes.
The company expects to enroll approximately 400 patients who have received up to one prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI) treatments. The trial is designed so patients either receive a 225 mg daily dose of X-396 or a 250 mg dose twice a day of standard-of-care crizotinib over a 28-day schedule.
About X-396 (Ensartinib)
Xcovery’s lead asset is X-396, a small molecule, anaplastic lymphoma kinase (ALK) inhibitor. It is being studied in the eXalt2 and eXalt3 studies, Phase 2 and Phase 3 trials for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Both studies are currently enrolling patients.