Policy & Regulation
Xcovery Commences Phase 2 Clinical Trial for Ensartinib in Certain Melanoma Patients
9 February 2018 - - US-based cancer therapeutics developer Xcovery has initiated its Phase 2 clinical trial of ensartinib (X-396), the company's lead anaplastic lymphoma kinase drug candidate, in patients with advanced malignant melanoma harboring alterations in ALK, including ALKATI, the company said.
The primary objective of the study is to determine the clinical benefit rate (CBR) of ensartinib in this patient population. CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumors (RECIST) 1.1 or stable disease until the 24-week assessment.
This is an open label, single arm Phase 2 study, enrolling patients with melanoma either currently or previously having received a PD-1 based therapy and, if BRAF V600 mutated, a BRAF-based therapy.
The study is comprised of two portions: the screening phase and treatment phase. In the screening phase, archival tumor tissues from patients deemed to be current or future candidates for this trial will be tested for the ALKATI alteration using a Nanostring-based RNA assay at MSK. Patients whose tumors express ALKATI will be eligible for the treatment phase.
Ensartinib (X-396) is a potent anaplastic lymphoma kinase inhibitor currently in a global Phase 3 trial in ALK positive non-small cell lung cancer patients. Besides ALK, ensartinib also potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.
Xcovery is working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors.