Biotechnology Company Announces Promising Data From Advanced Pancreatic Cancer Study
XBiotech's Phase 1/2 Study on Advanced Pancreatic Cancer: A Detailed Review.
Disclaimer: The information provided in this article is for informational purposes only. It should not be considered as medical advice or a recommendation for any treatment plan. Always consult with a healthcare professional before making any medical decisions. The findings discussed herein are based on the results of a specific clinical study and may not be applicable to all patients.
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XBiotech (NASDAQ: XBIT) recently announced promising data from its Phase 1/Phase 2 randomized, double-blind, placebo-controlled multi-center study for advanced pancreatic cancer. Named 1-BETTER, this study focused on evaluating Natrunix, an anti-interleukin-1alpha antibody, in combination with a well-established chemotherapy regimen comprising ONIVYDE (ON), 5-Fluorouracil (5FU), and Leucovorin (LV). This chemotherapy regimen is commonly employed in treating pancreatic cancer but is associated with challenging toxicities and suboptimal survival outcomes. Natrunix was evaluated not only as an anti-cancer agent but also for its potential to enhance the tolerability of the chemotherapy.
Phase 1 Study: Dose Escalation
The initial phase of the study was a dose escalation trial aimed at determining whether dose-limiting toxicities (DLTs) would occur when Natrunix was combined with the ON + 5FU + LV regimen in patients with metastatic pancreatic cancer undergoing second- or third-line therapy. DLTs were not anticipated with Natrunix, and none were observed. Consequently, the highest dose used in the Phase 1 portion was selected for the Phase 2 study. In the Phase 2 segment, 65 subjects were randomized into two groups on a 1:1 basis. The first group (Arm 1) received Natrunix in combination with ON + 5FU + LV, while the second group (Arm 2) received a placebo along with the same chemotherapy regimen. Arm 1 included 33 subjects, and Arm 2 had 32. The Phase 2 treatment period spanned 24 weeks, during which subjects received therapy every other week for a total of 12 cycles.
Subjects included in the study had confirmed metastatic, unresectable, or recurrent pancreatic adenocarcinoma of the exocrine pancreas. They were required to have experienced disease progression after one prior gemcitabine-based therapy or one FOLFIRINOX and gemcitabine-containing therapy. Additionally, all patients needed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
The primary endpoint of the Phase 2 study was to assess the safety and tolerability of Natrunix when used in conjunction with the ON + 5FU + LV combination. Overall, there were fewer adverse events (AEs) of any type during the 24-week treatment period for the Natrunix arm compared to the placebo arm (297 vs. 336). In specific categories of adverse events, the reduction was even more pronounced. There was a 28% decrease in the number of subjects experiencing severe adverse events (SAEs) in the Natrunix arm (9 out of 33) compared to the placebo arm (12 out of 32) within the 24-week treatment period.
Hospitalization and Quality of Life Metrics
Subjects receiving the Natrunix + ON + 5FU + LV regimen also experienced a 33% reduction in hospitalization days (80 days versus 120 days) compared to those receiving the placebo + ON + 5FU + LV combination. Furthermore, quality of life improvements were noted, with subjects in the Natrunix group reporting a 22% reduction in fatigue (28 vs. 36), a 32% improvement in appetite (19 vs. 28), and a 41% reduction in pain (17 vs. 29) by the end of the 24-week treatment period compared to those in the placebo group. Severe diarrhea, a potentially life-threatening complication associated with the ON + 5FU + LV regimen, saw a notable reduction in incidence among patients receiving the Natrunix combination. Specifically, there was a two-fold decrease (9% versus 19%) in the occurrence of severe diarrhea during the 24-week treatment period for patients in the Natrunix arm compared to those in the placebo arm.
Overall Survival (OS) was one of the secondary endpoints for the Phase 2 study. It was conventionally defined as the time from randomization to death. The results of the study indicated that Natrunix might play a role in improving the overall survival rates for patients undergoing this treatment regimen. Detailed survival data beyond the 24-week treatment period were not provided in the initial announcement and will require further follow-up and analysis.
The data presented by XBiotech from the Phase 1/2 study suggest that Natrunix, when combined with the ON + 5FU + LV regimen, could potentially offer a new therapeutic avenue for patients with advanced pancreatic cancer. The study demonstrated that Natrunix not only appeared to reduce the incidence of adverse events and hospitalizations but also seemed to improve various quality of life metrics such as fatigue, appetite, and pain. Additionally, the reduction in severe diarrhea incidence is particularly noteworthy, given its impact on patient outcomes and treatment adherence. While these findings are encouraging, it is essential to approach them with caution. The results are preliminary and based on a specific cohort of patients within a controlled study environment. Further research, including larger-scale studies and long-term follow-up, will be necessary to validate these outcomes and fully understand the potential benefits and risks associated with Natrunix in combination with standard chemotherapy regimens for pancreatic cancer.
For patients and healthcare providers, these initial results provide a glimmer of hope in the ongoing battle against advanced pancreatic cancer. As always, treatment decisions should be made on an individual basis, taking into account the unique circumstances and medical history of each patient.
Disclaimer: The information provided in this article is for informational purposes only. It should not be considered as medical advice or a recommendation for any treatment plan. Always consult with a healthcare professional before making any medical decisions. The findings discussed herein are based on the results of a specific clinical study and may not be applicable to all patients.
Real-time information is available daily at https://stockregion.net