Enrollment for Metastatic Non-Small Cell Lung Cancer Trial Cleared by FDA

Enrollment for Metastatic Non-Small Cell Lung Cancer Trial Cleared by FDA

BeyondSpring Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) is allowing enrollment in the Phase 1/2 clinical trial to access the company’s drug plinabulin in combination with nivolumab for the treatment of metastatic non-small cell lung cancer (NSCLC).

“This clinical trial provides further opportunity to assess the mechanism of Plinabulin in a combination treatment while collecting much-needed information about the safety and preliminary efficacy profile of the combination,” said Dr. Lan Huang, BeyondSpring Co-founder, Chairman and CEO in a recent press release.

Dr. Lyudmila Bazhenova, of the University of California San Diego Moores Cancer Center, was notified in mid June  about enrollment. Bazhenova, who will lead the trial, submitted an investigator-sponsored Investigational New Drug Application (IND) last May.

The clinical trial will investigate the maximum tolerated dose and, or recommended Phase 2 dose of Plinabulin combined with Nivolumab for the treatment of patients with metastatic NSCLC.

Plinabulin is a small molecule immune-oncology compound able to activate the maturation of dendritic cells (important cells of the immune system), inducing the activation of tumor antigen specific T-cells. The anti-cancer agent targets and alters the tumor microenvironment.

Nivolumab, marketed as Opdivo, is a humanized IgG4 anti-PD-1 monoclonal antibody that has proven response in NSCLC compared to standard care. Nivolumab works as a checkpoint inhibitor, blocking a signal that would have prevented activated T-cells from attacking the cancer.

“The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin,” Bazhenova said. “We anticipate that the combination study may lead to additional synergistic efficacy with Nivolumab and a well-tolerated safety profile.”

Lung cancer is the leading cause of cancer-related mortality worldwide. In 2012, approximately 1.8 million new cases were diagnosed and 1.6 million estimated deaths were caused by the disease. Lung cancer is manifested in two main forms: NSCLC and small cell lung cancer (SCLC). NSCLC is the more common form, accounting for approximately 85% of all lung cancer cases.

BeyondSpring Pharmaceuticals is a biopharmaceutical company developing novel cancer treatments, including Plinabulin and other compounds in partnership with the Fred Hutchinson Cancer Research Center.

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