Onconova Therapeutics Inc. (NASDAQ: ONTX) has releases interim efficacy and safety data from the investigator-initiated Phase 1/2, a study of oral rigosertib combination with immune checkpoint inhibitor nivolumab in treating advanced KRAS mutated non-small cell lung cancer.
Onconova to presents data on a rigosertib-nivolumab combination
The findings, which will be presented at the 3rd Annual RAS Targeted Drug Development Summit, confirm rigosertib-nivolumab combination therapy’s potential anti-cancer effectiveness in this indication. Equally, the data reveals that the combination has been tolerated well so far. Around 75% of the patients in the study had previously failed two or more lines of therapy, and all had previously failed immune checkpoint inhibitors combinations.
Onconova CEO Steven Fruchtman said, “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.”
Rigosertib combination with immune checkpoint well tolerated
Principal investigator Rajwanth Veluswamy said, “Combining rigosertib with the immune checkpoint inhibitor nivolumab has been well tolerated and notably led to partial responses in 29% of evaluable patients who had previously progressed on prior checkpoint inhibitor therapies. This safety and early efficacy signal highlights the combination of rigosertib and nivolumab’s ability to target KRAS mutated NSCLCs and potentially overcome immune checkpoint inhibitor resistance mechanisms. Importantly, responses were seen with different KRAS+ variants, addressing a critical unmet need.”
