A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer

Lee S Schwartzberg, Francis P Arena, Bryan J Bienvenu, Edward H Kaplan, Luis H Camacho, Luis T Campos, J Paul Waymack, Mary A Tagliaferri, Michael M Chen, Dapeng Li, Lee S Schwartzberg, Francis P Arena, Bryan J Bienvenu, Edward H Kaplan, Luis H Camacho, Luis T Campos, J Paul Waymack, Mary A Tagliaferri, Michael M Chen, Dapeng Li

Abstract

Background: This study was designed to assess the safety and preliminary efficacy of KLTi plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer. Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreatic cancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Three sequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at 1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and 15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primary endpoint was progression-free survival in the ITT population. Safety evaluation was based on patients who received any study treatment. ClinicalTrials.gov identifier NCT00733850. Results: Eighty-five patients were randomized including 41 (28:13) in Cohort 1, 18 (12:6) in Cohort 2, and 26 (17:9) in Cohort 3. Due to a different dose and/or shift in patient populations in Cohort 2 and 3, efficacy data for the 30 gm dose are presented in this manuscript for Cohort 1 alone, and for the combination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significant improvement in progression-free survival (PFS) as assessed by blinded independent radiology review in the ITT population, with a median of 112 days, versus 58 days in the gemcitabine group (HR 0.50; 95% CI: 0.27, 0.92), p = 0.0240. The incidence rates of TEAEs, CTCAE Grade 3 or higher TEAEs, and SAEs were similar between the two arms. There were no deaths related to KLTi + gemcitabine treatment. Conclusion: Kanglaite Injection (30 g/day) plus a standard regimen of gemcitabine demonstrated encouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.

Keywords: Kanglaite Injection; coix seed; pancreatic cancer; traditional Chinese medicinal herb..

Conflict of interest statement

Competing Interests: Lee Schwartzberg and Francis Arena have received consulting fees from KangLaiTe USA, Inc. Mary Tagliaferri and Michael Chen are former employees of KangLaiTe USA, Inc. J. Paul Waymack is a consultant of KangLaiTe USA, Inc. Dapeng Li is an employee of KangLaiTe USA, Inc. The authors have declared that no other competing interest exists.

Figures

Figure 1
Figure 1
Patient Disposition
Figure 2
Figure 2
Cohort 1-Kaplan-Meier Plot of Progression-Free Survival by Radiologic Assessment (ITT Population)
Figure 3
Figure 3
Kaplan-Meier Plot of Overall Survival (ITT Population)
Figure 4
Figure 4
Cohort 1+3-Kaplan-Meier Plot of Progression-Free Survival by Radiologic Assessment (ITT Population)
Figure 5
Figure 5
Cohort 1+3 Kaplan-Meier Plot of Overall Survival (ITT Population)
Figure 6
Figure 6
Time to the Most Common Grade 3 or Above TEAEs Associated with Gemcitabine Monotherapy

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