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Onconova to Enroll Patients With KRAS-Mutated Lung Cancer in Phase I/II Rigosertib Trials

NEW YORK – Onconova Therapeutics said on Monday that an investigator-initiated Phase I/II trial of rigosertib combined with the anti-PD-1 antibody nivolumab (Bristol Myers Squibb's Opdivo) in KRAS-mutated lung adenocarcinoma is now enrolling patients at the Icahn School of Medicine at Mount Sinai.

The open-label study will investigate the safety and efficacy of the drug combination in patients who have progressed on or are intolerant to standard-of-care, first-line treatment with either an anti-PD-1 checkpoint inhibitor monotherapy or anti-PD-1 checkpoint inhibitor in combination with platinum doublet chemotherapy.

Patients are required to have their KRAS mutation confirmed through next-generation sequencing either at time of diagnosis or at progression on first-line treatment. The study will not enroll patients whose tumor harbors an EGFR-activating mutation or an ALK translocation.

Rigosertib is a small molecule designed to block RAS signaling. Onconova is also exploring the drug's activity in patients with myelodysplastic syndromes. 

"The novel combination of rigosertib with an anti-PD-1 antibody targets two of the most important oncogenic pathways in cancer biology," said Rajwanth Veluswamy, assistant professor at the Icahn School of Medicine at Mount Sinai and lead investigator on the study. "The study will explore efficacy of the combination in this common lung cancer subset and will also determine if rigosertib may restore sensitivity to PD-1 blockade."