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Onconova's Cancer Study Fails to Meet Endpoint, Shares Down

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Shares of Onconova Therapeutics, Inc. (ONTX - Free Report) fell slumped 66.7% after it announced that the phase III INSPIRE study onintravenous (IV) rigosertib in higher-risk myelodysplastic syndromes (HR-MDS) patients did not meet theprimary endpoint of improved survival.Myelodysplastic syndromes (MDS) are a group of cancers, in which immature blood cells in the bone marrow do not mature and so do not become healthy blood cells.

Shares of the company have lost 10.5% year to date compared with the industry’s decline of 6.5%.

The phase III INSPIRE study evaluated the efficacy and safety of intravenous (IV)rigosertib in patients with HR-MDSwho had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylatingagent (HMA). The primary endpoint of INSPIRE was overall survival. A pre-specified analysis in a very high-risk (VHR-MDS) patient subgroup was also conducted.

Patients were randomized 2:1 to receive either IV rigosertib plus best supportive care or physician's choice (PC) plus best supportive care. Overall, results from the study demonstrated thatpatients randomized to IV rigosertib achieved an overall survival (OS) of 6.4 monthsversus 6.3 months for physician’s choice in the total HR-MDS population.

This showed that the OS findings were not significantly different for patients who were treated with either rigosertib or PC.

Overall survival in the pre-specified VHR-MDS subgroup of patients was also not significantly different between the two study arms. The post-interim analysis showed that there was an increase in overall survival in the PC arm, which was unexpected. Moving forward, Onconova Therapeutics intends to conduct additional analyses to further validate these study findings.

After these disappointing results, the company stated that it will focus on the investigator-initiated study program with oral rigosertib beyond the ongoing phase I/IIa study in KRAS+ lung adenocarcinoma into additional solid tumors. 

Zacks Rank & Other Stocks to Consider

Onconova currently carries a Zacks Rank #2 (Buy).

Some better-ranked stocks in the sector include Pacira BioSpecifics Inc. (PCRX - Free Report) , BioLineRx Ltd. (BLRX - Free Report) and BioPath Holdings Inc (BPTH - Free Report) . While Pacira sports a Zacks Rank #1 (Strong Buy), BioLineRx and BioPath carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Pacira’s earnings per share estimates have increased from $1.78 to $2.06 for 2020 and from $3.12 to $3.62 for 2021 in the past 60 days.

BioLineRx’s loss per share estimates have narrowed from $2.24 to $1.95 for 2020 and from $2.88 to $1.44 for 2021 in the past 60 days.

BioPath’s loss per share estimates have narrowedfrom $3.77 to $3.14for 2020 and $2.88 to $2.42 for 2021in the past 60 days.


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