Dr. Wang-Gillam on Results of a Phase 1 Study With Defactinib in Pancreatic Ductal Adenocarcinoma

Andrea Wang-Gillam, MD, PhD, associate professor, Department of Medicine, Oncology Division of Molecular Oncology, Washington University School of Medicine in St. Louis, discusses the results of a phase 1 study with defactinib in patients with pancreatic ductal adenocarcinoma (PDAC).

In a phase I study (NCT02546531), investigators evaluated the investigational FAK inhibitor defactinib in combination with pembrolizumab (Keytruda) and gemcitabine. The findings, which were presented as part of the virtual platform for the 2020 AACR Annual Meeting, demonstrated efficacy signals in both the maintenance and relapsed/refractory settings in patients with metastatic PDAC.

As part of the dose-expansion portion of the trial, patients enrolled in the maintenance cohort were required to have stable disease following frontline therapy with gemcitabine/nab-paclitaxel (Abraxane), says Wang-Gillam. Patients who progressed on 1 or more lines of systemic therapy were enrolled in the refractory cohort. This regimen could also be beneficial as a second-line option for these patients, adds Wang-Gillam.

In the dose-expansion cohort, patients received 400 mg of defactinib twice daily, 1000 mg/m² of gemcitabine on days 1 and 8, and 200 mg of pembrolizumab on day 1 of a 21-day cycle. The regimen was well-tolerated in both cohorts. Updated outcomes and correlative analyses are to be presented in the future.