The FDA notified Lyudmila Bazhenova, MD, at the UC San Diego Moores Cancer Center that the phase I/II study of nivolumab in combination with plinabulin for patients with metastatic non-small cell lung cancer (NSCLC) may proceed with enrolling patients. This follows Bazhenova's submission of an investigator-sponsored Investigational New Drug Application on May 23, 2016.
The study objectives are to define the maximum tolerated dose and/or recommended phase II dose of plinabulin in combination with nivolumab for patients with metastatic NSCLC.
The small molecule immuno-oncology agent, plinabulin, activates dendritic cell maturation, induces tumor antigen specific T-cell activation and down-regulates Treg. Nivolumab is a programmed cell-death-1 inhibitor that has activity in NSCLC, compared to standard of care.
"The granting of this clearance to begin enrolling patients is an exciting next step for the development of plinabulin," said Bazhenova. "We anticipate that the combination study may lead to additional synergistic efficacy with nivolumab and a well-tolerated safety profile."