Onconova Therapeutics Inc. (NASDAQ: ONTX) was absolutely crushed to start out the week after the company reported results from its late-stage cancer study. The study did not meet the primary endpoint, leaving some questions for the company.
Specifically, the results are coming from the Phase 3 Inspire study, assessing the efficacy and safety of IV rigsertib in higher-risk myelodysplastic syndromes (HR-MDS).
The primary endpoint of the trial was overall survival. The study was comparing IV rigosertib plus best supportive care versus physician’s choice (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.
Results of the Inspire study demonstrated that in the intent-to-treat analysis patients randomized to IV rigosertib achieved overall survival of 6.4 months, versus 6.3 months for PC in the overall HR-MDS population. Overall survival in the pre-specified VHR-MDS subgroup of patients also was 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. The company is conducting additional analyses.
Safety analysis indicated that IV rigosertib generally was well tolerated, with reported adverse events similar to those observed in previous clinical studies with IV rigosertib in MDS. Serious adverse events were uncommon, with a similar profile of such events in both study arms.
Management noted that it is fortunate to have built a product pipeline that includes multiple promising agents, including oral rigosertib and ON 123300. Both compounds target meaningful cancer pathways, and the firm is looking forward to further efforts with these programs. Accordingly, it will review pipeline and in-licensing opportunities both internally and with external advisors
Ononova was last seen down about 70% at $0.30, in a 52-week range of $0.10 to $2.84. The consensus price target is $2.08.
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