Andrea Wang-Gillam, MD, PhD, assistant professor, Department of Medicine, Oncology Division, Washington University School of Medicine and Siteman Cancer Center in St. Louis, discusses the trial design and results of the phase III NAPOLI-1 trial that examined MM-398 with 5-fluorouracil (5-FU) and leucovorin in patients with metastatic pancreatic cancer following progression on gemcitabine-based therapy.
Wang-Gillam says the primary endpoint of the study was overall survival (OS) and secondary endpoints included progression-free survival and response rate. The study was done globally and recruited patients from over 100 sites. The study had 3 arms, one examining MM-398 monotherapy, the second looking at 5-FU with leucovorin (control), and the third examined the combination of MM-398, 5-FU, and leucovorin.
Results of the study showed that the combination arm of MM-398 plus 5-FU/leucovorin had a superior OS compared with 5-FU/leucovorin alone (OS = 6.1 months vs 4.2 months). The combination of MM-398 plus 5-FU/leucovorin also showed superior progression-free survival (PFS), overall response rare (ORR), and CA19-9 response.
The median PFS was 3.1 months for the combination compared with 1.5 months with the control (HR = 0.56; 95% CI, 0.41-0.75; P
= .0001). The ORR was 16% versus 1% (P
<.001) and CA19-9 levels were decreased by ≥50% in 36% versus 12% of patients in the combination and control arms, respectively.
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