ASCO24: Promising mid-stage survival readout for Purple Biotech’s pancreatic cancer antibody

2024-06-04

临床结果ASCO会议临床2期

Purple Biotech’s CM24, a humanised mAb directed against CEACAM1, demonstrated significant gains on overall survival (OS) and progression-free survival (PFS) in a Phase II study for second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The interim results were unveiled in a late-breaking abstract poster at the American Society of Clinical Oncology (ASCO) annual meeting.

The trial investigated CM24 in combination with Bristol Myers Squibb’s Opdivo (nivolumab) plus standard-of-care chemotherapy versus chemotherapy alone in 63 previously treated patients with metastatic PDAC. The experimental and control cohorts were further divided into two arms each based on the choice of chemotherapy used - gemcitabine/nab-paclitaxel or liposomal irinotecan/5-fluorouracil and leucovorin (Nal-IRI/5FU/LV). The primary endpoint was OS, with PFS being a key secondary goal.

Substantial survival advantage

Preliminary results as of the May 8 cut-off for the Nal-IRI/5FU/LV segment involving 31 participants showed that the CM24-based regimen demonstrated a 26% improvement in OS and a 28% improvement in PFS compared with chemotherapy alone. The CM24-based regimen extended the median OS and PFS by 2.1 months and 1.9 months, respectively versus chemotherapy.

Furthermore, the CM24 group exhibited a higher objective response rate (25%), disease control rate and a greater reduction in CA19-9 biomarker levels compared with the chemotherapy group. Prior to the readout, HC Wainwright analysts predicted a PFS improvement of at least 30% adding that “an ORR of more than 20%…would be considered positive.”

Meanwhile, the CM24-based regimen was well tolerated, with common Grade 3 or higher adverse events being diarrhoea, fatigue and anaemia. “These data justify further investigation of CM24…to potentially improve outcomes for patients facing a very poor prognosis from this type of tumour,” remarked principal investigator Michael Cecchini.

Purple Biotech noted that the study’s gemcitabine/nab-paclitaxel segment will be analysed after the data are adequately mature, with the overall top-line final results likely to be ready by the end of the year.

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