Onconova Therapeutics Announces Encouraging Clinical Data Supporting The Anti-Cancer Activity Of Rigosertib-Nivolumab Combination In Advanced KRAS+ Non-Small Cell Lung Cancer

Preliminary Phase 1/2a trial data show an early signal of activity in extensively pre-treated population with 2 partial responses out of 7 evaluable patients

Responses were seen in patients with different KRAS mutations

Data supports further development of rigosertib, in combination with immune checkpoint inhibitors in KRAS mutated (KRAS+) non-small cell lung cancer

Management hosting webinar with key opinion leaders to discuss data today at 4:30 p.m. ET

NEWTOWN, Pa., Sept. 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preliminary safety and efficacy data from an investigator-initiated Phase 1/2a trial of oral rigosertib plus the immune checkpoint inhibitor nivolumab in advanced KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The data, which are being featured in a presentation at the 3^rd Annual RAS Targeted Drug Development Summit, support the potential anti-cancer activity of rigosertib-nivolumab combination therapy in this indication and show that the doublet has been well tolerated to-date. Three quarters of patients enrolled in the trial have failed two or more lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “The data being presented today support the potential applicability of rigosertib’s mechanism of action against multiple KRAS mutations and its synergy with immuno-oncology therapeutics. Radiographic responses were seen across multiple KRAS variants, which potentially differentiates rigosertib from other RAS pathway modulators that target particular KRAS mutations. These responses were observed at the primary tumor site as well as metastatic sites such as the pleura and bone. These results also suggest that rigosertib may augment the response to checkpoint inhibitors, which is consistent with observations from preclinical studies, with potential applicability to indications such as NSCLC, melanoma, and others. Looking forward, we will continue to leverage our investigator-initiated study program to advance rigosertib’s clinical development in high-need KRAS mutated indications while keeping our primary focus on our lead ON 123300 (narazaciclib) program.”

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