On Monday, Purple Biotech Ltd (NASDAQ: PPBT ) reported the final results from the randomized Phase 2 study of its lead oncology drug, CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with pancreatic ductal adenocarcinoma (PDAC) .
Purple Biotech stock is trading higher with a strong session volume of 9.7 million, compared to an average volume of 48.73K as per data from Benzinga Pro .
The Phase 2 study evaluated CM24 in combination with Bristol Myers Squibb & Co’s (NYSE: BMY ) immune checkpoint inhibitor nivolumab plus stand-of-care (SoC) chemotherapy in second-line metastatic PDAC patients versus SoC chemotherapy alone.
In the intent-to-treat cohort population, the median overall survival rate was 7.92 months in the CM24 combo treatment arm versus 5.55 months in the chemo arm.
The median progression-free survival was 3.9 months versus 2.0 months.
The overall response rate was 25% versus 7%, and the disease control rate was 63% compared to 47% in the CM24 combo arm vs. chemo alone group.
A consistent and continuous decrease of CA19-9, a clinically validated PDAC biomarker, was observed in the experimental arm, reaching a median percentage reduction from baseline of approximately 80% vs. an increase of 40% in the control arm.
A biomarker-enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control, with a 79% reduction in the risk of death and a median overall survival improvement of 5.1 months.
Over 90% reduction in risk of progression or death was observed, with a median progression-free survival improvement of 2.9 months and improvement in the treatment arm over the control, resulting in an overall response rate of 50% vs. 0%.
The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated. The most frequent treatment-emergent Grade 3 or higher adverse events were diarrhea, fatigue, and neutropenia.
Accordingly, no meaningful differences in safety and tolerability were observed between the experimental arm and the SoC arm.
Price Action: PPBT stock is up 54.1% at $5.17 during the premarket session at last check Monday.
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