Xcovery initiates Phase 2 Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations

Xcovery announced the initiation of its Phase 2 clinical trial of ensartinib (X-396), the company’s lead anaplastic lymphoma kinase (ALK) drug candidate, in patients with advanced malignant melanoma harboring alterations in ALK, including ALKATI. The trial is being conducted by the renowned Memorial Sloan Kettering Cancer Center (MSK) and led by MSK’s Dr. Alexander Shoushtari.

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 ALKATIalteration using a Nanostring-based RNA assay at MSK. Patients whose tumors express ALKATI will be eligible for the treatment phase.

“While there has been significant clinical advancements in the treatment of advanced malignant melanoma, 30 to 40 percent of patients do not respond to immune-based therapy or will develop therapeutic resistance. This is a promising trial that uses an RNA-based assay to identify an epigenentically-regulated tumor growth mechanism and if deemed favorable for further study, this trial could represent a new treatment option for patients who currently have few options,” said Alexander Shoushtari, M.D., Department of Medicine/Melanoma and Immunotherapeutics Services and principal investigator of the study at MSK.

“We are honored to collaborate with the distinguished scientists and investigators at MSK who were the first to discover this novel ALK alternation in melanoma patients,” said Lieming Ding, M.D., Chairman of Xcovery. “We hope that ensartinib will be a viable treatment option for these patients.”

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