Abstract | Background: Methods: In the open-label, phase 3 CanStem111P study (NCT02993731), adults with previously untreated metastatic pancreatic adenocarcinoma (mPDAC) were randomised (1:1) to napabucasin plus nab-paclitaxel with gemcitabine or nab-paclitaxel with gemcitabine alone. The primary endpoint was overall survival (OS). In exploratory analyses, OS was evaluated in the subgroup of patients with tumours positive for pSTAT3 ( biomarker-positive). Findings: Between 30 January 2017 and 20 February 2019, a total of 1779 patients were screened across 165 study sites in Austria, Australia, Belgium, Canada, China, Czech Republic, France, Germany, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Singapore, Spain, Taiwan, Ukraine, and the US. Of the 565 and 569 patients randomised to the napabucasin and control treatment arms, respectively, 206 and 176 were biomarker-positive. Median (95% confidence interval [CI]) OS in the napabucasin and control treatment arms was 11.4 (10.5-12.2) and 11.7 (10.7-12.7) months, respectively (hazard ratio, 1.07; 95% CI, 0.93-1.23). Due to the lack of OS improvement in the napabucasin arm, CanStem111P was terminated due to futility. In the biomarker-positive subgroup, no difference between treatment arms was found for OS. Grade ≥3 adverse events were reported in 85.4% and 83.9% of napabucasin-treated and control-treated patients, respectively. The incidence of gastrointestinal-related grade ≥3 events was higher with napabucasin (diarrhoea: 11.6% vs 4.9%; abdominal pain: 10.0% vs 4.8%). Interpretation: Funding: The Sumitomo Pharma Oncology, Inc.
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Authors | Tanios Bekaii-Saab, Takuji Okusaka, David Goldstein, Do-Youn Oh, Makoto Ueno, Tatsuya Ioka, Weijia Fang, Eric C Anderson, Marcus S Noel, Michele Reni, Hye Jin Choi, Jonathan S Goldberg, Sang Cheul Oh, Chung-Pin Li, Josep Tabernero, Jian Li, Emma Foos, Cindy Oh, Eric Van Cutsem |
Journal | EClinicalMedicine
(EClinicalMedicine)
Vol. 58
Pg. 101897
(Apr 2023)
ISSN: 2589-5370 [Electronic] England |
PMID | 36969338
(Publication Type: Journal Article)
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Copyright | © 2023 The Author(s). |
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