KEY TAKEAWAYS
- The phase I/II trial aimed to evaluate the safety and efficacy of batiraxcept, in combination with standard chemotherapy for advanced pancreatic cancer.
- The primary endpoints were safety and ORR. Secondary endpoints were PFS and OS.
- The study found batiraxcept in combination with gemcitabine and nab-paclitaxel was well tolerated and showed promising efficacy in advanced pancreatic cancer pts.
PDAC is a deadly, aggressive type of cancer with many stromal tissues, composed of macrophages, fibroblasts, and collagen. This stroma can make PDAC resistant to treatment. Researchers aimed to evaluate the safety and efficacy of batiraxcept, an AXL inhibitor, in combination with standard chemotherapy for advanced pancreatic cancer.
The study examined the combination of BT at 15 mg/kg on days 1 and 15 with G at 1000 mg/m2 and NP at 125 mg/m2 on days 1, 8, and 15 within a 28-day cycle. The primary endpoints were to assess safety and the objective response rate (ORR) using RECIST v1.1 criteria. Key secondary endpoints included evaluating progression-free survival (PFS) and overall survival (OS). Pharmacokinetic(PK) data were gathered to analyze the relationship between exposure and PFS response (E-R).
Of the 21 patients(pts) who received BT/G/NP, 10 were male (48%), and 3 (14%) had previous neoadjuvant/adjuvant therapy. Common BT-related side effects affecting more than 10% of pts included fatigue ( (n=7, 33%), diarrhea (n=4, 19%), infusion-related reactions, and neutropenia (n=3, 14%). Severe (Grade ≥ 3) BT-related side effects occurred in 6 pts (29%). BT treatment effectively reduced GAS6 levels throughout treatment. A total of 18 pts (86%) stopped treatment, mainly due to toxicity (n=2) and disease progression (n=13). The median treatment duration was 13.1 weeks (range 0.1─74.7). The objective response rate was 29%, with median progression-free survival (mPFS) at 5.4 months (2.1, 5.6) and median overall survival (mOS) at 12.3 months (4.11─NE). Efficacy was associated with a minimally efficacious concentration (MEC) of 14.5 mg/L based on exposure-response modeling.
The study found batiraxcept in combination with gemcitabine and nab-paclitaxel was well tolerated and showed promising efficacy in advanced pancreatic cancer pts.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e16258
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04983407
Vaibhav Sahai, Paul Eliezer Oberstein, Smitha S. Krishnamurthi, Nashat Y. Gabrail, Christos Fountzilas, Warren S. Brenner, Zev A. Wainberg, Hongxia Yan, Gail McIntyre, Charles D. Lopez, Niharika B. Mettu, and Robert B. Geller. DOI: 10.1200/JCO.2023.41.16_suppl.e16258 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e16258-e16258.
