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Onconova: Phase 3 INSPIRE Trial Did Not Meet Primary Endpoint Of Improved Survival

(RTTNews) - Biopharmaceutical company Onconova Therapeutics, Inc. (ONTX) said Monday that INSPIRE, the company's pivotal Phase 3 study assessing the efficacy and safety of IV rigosertib in higher-risk myelodysplastic syndromes (MDS) or HR-MDS patients, did not meet its primary endpoint of improved survival.

The primary endpoint of the trial was overall survival, comparing IV rigosertib plus best supportive care to physician's choice or PC plus best supportive care in patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment.

A pre-specified analysis in the very high risk (VHR-MDS) patient subgroup was also conducted.

Results of INSPIRE demonstrated that in the intent-to-treat analysis patients randomized to IV rigosertib achieved overall survival of 6.4 months, compared to 6.3 months for PC in the overall HR-MDS population.

The company also noted that overall survival in the pre-specified VHR-MDS subgroup of patients was also not significantly different between the two study arms. There was an increase in overall survival in the PC arm post-interim analysis that was unexpected. Onconova said it is conducting additional analyses.

The company said it will focus on promising pipeline opportunities, including with its CDK4/6 + ARK5 inhibitor ON 123300.

"We also look forward to the continued expansion of the investigator-initiated study program with oral rigosertib beyond the ongoing Phase 1/2a study in KRAS+ lung adenocarcinoma into additional solid tumors. Our novel CDK4/6 + ARK5 inhibitor, ON 123300, could also represent a meaningful advance over existing products," Richard Woodman, Chief Medical Officer of Onconova.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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