XB2001 Treatment for Advanced Pancreatic Cancer Shows Promising Results in Reducing Adverse Effects

Introduction

XBiotech has recently announced promising findings in treating advanced pancreatic cancer using its experimental regimen, XB2001, in combination with chemotherapy.

Reduced Adverse Effects and Improved Survival Rates

The findings reveal that patients in the XB2001 arm experienced fewer adverse effects (297 total AEs vs. 336 total AEs) during the 24-week treatment period compared to those in the placebo arm. Additionally, the experimental regimen was found to result in a 28% decrease in the rate of patients who experienced significant AEs, with significant AEs occurring in 9 of 33 patients in the XB2001 arm vs. 12 of 32 patients in the placebo arm.

The study also found that XB2001 plus chemotherapy resulted in a requirement of only 80 days of hospitalization within the 24-week treatment period compared to 120 days for those who received the placebo plus chemotherapy.

Regarding efficacy, eight patients in the XB2001 arm survived up to the 330th day, whereas no patients in the placebo arm had survived for more than 330 days. Although the survival rate difference falls at the border of statistical significance, the findings are still impressive, given the limited sample size.

Physician’s thoughts

David J. Park, the lead study investigator and a medical oncologist and medical director for the Providence St. Jude Crosson Institute in Fullerton, California, expressed his thoughts on the results in a news release. He stated that “To observe these trends for reduced toxicity and potential survival benefit is remarkable, particularly given the limited sample size. The potential interaction between reduced toxicity, more time on treatment, and improvement in survival makes intuitive sense for clinicians who treat these patients. These findings are extremely important.”

Study Details

The 1-BETTER study enrolled patients of at least 18 years of age with histologically or cytologically confirmed metastatic, unresectable, or recurrent pancreatic adenocarcinoma of the exocrine pancreas. They were required to have at least 1 measurable lesion per RECIST v1.1 criteria, documented disease progression after one prior gemcitabine-based or FOLFIRINOX/gemcitabine combination therapy, an ECOG performance status of 0 or 1, or a Karnofsky performance status of at least 70, and adequate hepatic, renal, and bone marrow function.

Phase 1 of 1-BETTER was an open-label, dose-escalation study designed to identify the maximum tolerated dose (MTD) and recommended phase 2 dose of XB2001 in combination with chemotherapy. In phase 2, patients were randomly assigned 1:1 to receive XB2001 at the MTD or placebo in combination with irinotecan liposome at 70 mg/m2, leucovorin at 400 mg/m2, and 5-FU at 2400 mg/m2 once every 2 weeks. Safety and defining the MTD were the trial’s primary end points, while secondary endpoints included progression-free survival, OS, objective response rate, time to treatment failure, clinical benefit rate, quality of life, and safety.

Additional Safety Data

Additional safety data from the randomized portion of the study showed that the XB2001 regimen was tied to a 22% reduction in fatigue, a 32% improvement in appetite, and a 41% reduction in pain as of the last day of the 24-week treatment period. Notably, severe diarrhea was reported in 9% of patients in the XB2001 arm vs. 19% of patients in the placebo arm during the 24-week treatment period.

Conclusion

These findings are promising in treating advanced pancreatic cancer, especially in reducing adverse effects. The XB2001 regimen’s potential interaction between reduced toxicity, more time on treatment, and improvement in survival makes it extremely important in treating pancreatic cancer. We hope the continuous research and clinical trial of the XB2001 regimen will lead to an innovative and effective treatment of pancreatic cancer soon.

Keywords: XB2001, pancreatic cancer treatment, adverse effects, survival rate, chemotherapy.

Originally Post From https://www.onclive.com/view/addition-of-xb2001-to-chemo-improves-safety-in-advanced-pancreatic-cancer

Experience Safer Chemo for Advanced Pancreatic Cancer with XB2001 – OncLive