Onconova Therapeutics Inc (NASDAQ:ONTX) says the Pivotal Phase 3 INSPIRE trial did not meet its Primary Endpoint

Onconova Therapeutics Inc (NASDAQ:ONTX) has been conducting trials on novel drugs to treat cancer. The company has a strong pipeline of proprietary targeted agents and continues to focus on the discovery and development of other solutions, directly addressing the disease and its recurrence. However, the company has lost on one of its trials; for INSPIRE.

The company’s pivotal Phase, 3 study of IV rigosertib, was a disappointment, according to Onconova’s CEO Steven M. Fruchtman. INSPIRE trial, which assessed the efficacy and safety, did not meet the required primary endpoint of improved survival. Instead, the results indicated an overall survival in higher-risk MDS (HR-MDS) patients. Nonetheless, comparing it with IV rigosertib plus best supportive care, the overall survival failed to respond or relapsed after previous treatment.

What is next for the company after this Setback?

Success and failure go hand in hand in business. The company has previously conducted successful trials, and its passion for improving the outcome for cancer patients is very clear. Thus, then the failure of the INSPIRE trial should not be a discouragement but an eye-opener.

“Onconova is fortunate to have built a product pipeline that includes multiple promising agents, including oral rigosertib and ON 123300. The company will review pipeline and in-licensing opportunities both internally and with external advisors,” Fruchtman commented.

Despite the disappointment from the INSPIRE data readout in HR-MDS, oral rigosertib could address various oncology settings outside of hematology and if used RAS pathway inhibitor. This is according to Onconova’s Chief Medical Officer, Richard C. Woodman. He says that there is a lot of learning from the genomic analyses of the INSPIRE trial. They will use them to drive future development of rigosertib.

The Expansion of a Pre-IND Stage Program

Onconova says; meanwhile, it will turn its focus on the continued expansion of its investigator-initiated study program addressing CDK4/6 and Ark5 inhibitor, ON 123300. The evaluation of KRAS+ lung adenocarcinoma is also ongoing in an open-label phase 1/2a study. Word has it that rigosertib is also und undergoing evaluation in patients with coronavirus. An application with the National Institute of Allergy and Infectious Disease has already been submitted for funding from the National Institutes of Health.