Spirita Oncology, LLC Initiates a Phase 1 Clinical Trial of the Anti-Cancer Agent E6201 in Combination with Dabrafenib in Patients with Central Nervous System Metastases from BRAF V600 Mutated Metastatic Melanoma

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BOSTON–(BUSINESS WIRE)–Spirita Oncology, LLC, has initiated a Phase 1 clinical trial of anti-cancer agent E6201 in combination with dabrafenib in patients with BRAF V600-mutated metastatic melanoma that has spread to the central nervous system.

There are approximately 47,000 new cases of metastatic melanoma in the U.S. each year, with approximately 10,000 deaths. More than 15,000 of these patients develop brain metastases. The median overall survival for patients with brain metastases is four months. Approximately 50% of patients harbor BRAF- or MEK-mutated melanoma, with limited treatment options available. Targeted therapies and immune checkpoint inhibitors have improved overall survival for metastatic melanoma patients with brain metastases. However, responses are usually of short duration, and new agents that effectively penetrate the blood-brain-barrier (BBB) are needed.

E6201 is an ATP-competitive MEK1 inhibitor that has demonstrated preclinical activity in BRAF V600-mutant melanoma cell lines. E6201 has shown excellent brain distribution characteristics and minimal CNS efflux by transporters at the BBB. A Phase 1 trial (NCT00794781) evaluating E6201 in patients with advanced solid tumors demonstrated activity in metastatic melanoma patients, including two patients with brain metastases, one of whom maintained an exceptional ongoing durable response lasting for more than 10 years.

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