08:23 AM EST, 12/02/2024 (MT Newswires) -- Purple Biotech ( PPBT ) said Monday the phase 2 study evaluating its lead oncology drug, CM24, in combination with nivolumab and standard-of-care chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma, or PDAC, showed positive final results.
The study involved 63 patients and compared CM24 plus nivolumab with chemotherapy in second-line metastatic PDAC versus chemotherapy alone.
The company said the CM24 plus nivolumab and chemotherapy demonstrated "clear and consistent improvement across all efficacy endpoints."
Key results showed a median overall survival of 7.92 months in the experimental arm versus 5.55 months in the control arm. The progression-free survival was also improved, with a median of 3.9 months compared with 2 months in the control group. The overall response rate was 25% for the experimental arm, compared with the 7% observed in the control group.
The regimen was well tolerated, with "no meaningful difference in safety and tolerability were observed between the experimental arm and SoC arm."
Purple Biotech ( PPBT ) said it plans a 3-arm phase 2b trial comparing CM24 plus a PD1 inhibitor or CM24 monotherapy to SoC in multiple tumor types.
Purple Biotech ( PPBT ) shares were up over 53% in recent premarket trading.
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