US-based biopharmaceutical company Xcovery has begun the Phase III eXalt3 trial of X-396 to treat anaplastic lymphoma kinase (ALK) positive, non-small cell lung cancer (NSCLC).
X-396 is a small molecule, which acts as an inhibitor of anaplastic lymphoma kinase (ALK).
The open-label, randomised Phase III eXalt3 trial is designed to evaluate the efficacy and safety of X-396 against crizotinib.
The trial has involved more than 400 patients afflicted with ALK+ NSCLC and had a prior treatment history with one chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI) treatments.
Xcovery president and CEO Michael Webb said: "The initiation of our Phase 3 eXalt3 trial represents an important step forward in Xcovery's advancement of our lead candidate, X-396.
"The recently released data from our ongoing Phase I/II study of X-396 showed promising activity with durable responses noted in both treatment-naïve patients, as well as in patients resistant to current standard-of-care.
"These results, coupled with a favourable 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."
The trial primarily focuses on determining the progression-free survival (PFS) as assessed by an independent radiology review based on RECIST v. 1.1 criteria.
The study additionally intends to evaluate the pharmacokinetic profile of X-396 on selected patients, while samples for exploratory biomarkers research will be compared against the clinical outcomes.