Abstract 2393: Development of a novel implantable drug-eluting product for the local treatment of pancreatic adenocarcinoma

Abstract Background Local control of non-metastatic pancreatic ductal adenocarcinoma (PDAC) remains a major challenge. Therapies with reduced systemic toxicity are needed as intravenous (IV) infusions are limited by patient tolerance with only small amounts reaching the tumor. PanTher created PTM-101, a novel absorbable drug formulation containing paclitaxel, designed to be locally applied via minimally invasive surgery to provide chemotherapy precisely to the peritumoral area in PDAC. Methods A study was conducted using 3 cadaveric abdomens to evaluate surgical feasibility of delivering PTM-101 via laparoscopy. Prior to insertion of PTM-101 into the peritoneum, the surgeons prepared each product by suturing a 3-0 Vicryl SH (Ethicon) at four evenly spaced locations around the edge of the flat circular product. A periumbilical 10mm Hasson port was placed to insufflate the abdomen, followed by placement of 3 additional working ports (5mm). The liver capsule was carefully surveyed to exclude metastatic disease. The surgeons opened a window into the lesser sac through the greater omentum, lifting the stomach up from the transverse colon to expose the pancreas. PTM-101 (a 1mm thick and 6cm diameter film) was rolled into a tubular shape, inserted through the cannula, and affixed to the peri-pancreatic fat with existing vicryl stitches. Results The estimated total operative time from placement of the first trocar to removal of all equipment was 45 minutes, for the 3 procedures. The operations included 25 minutes for entry, port placement, exposure of the simulated pancreatic tumor location and 20 minutes to place and suture PTM-101. PTM-101 was easy to fit through the cannula and was sutured without difficulty to the peri-pancreatic fat that surrounds the capsule of the pancreas. To simulate a tumor with hepatic artery involvement, the implant was sutured towards the hepatoduodenal ligament in one specimen, near the area of the gastroduodenal artery takeoff, proper hepatic artery, and proximal portal vein. PTM-101 covered the entire head/neck area of the simulated tumor locations without requiring disruption of the tumor area or dissection of the tunnel under the pancreatic neck. Conclusion PTM-101 is flexible and conforms easily to the underlying topography, both in a concave (i.e., with the tumor intact) and convex (i.e., after resection) scenario. Although human anatomy does not allow for PTM-101 to completely wrap around the pancreas, the size and flexibility of the product enables it to “drape” over the edges covering areas near the superior mesenteric vein and artery (SMV/SMA). This placement could hypothetically increase the amount of drug reaching the area behind the pancreas to target tumors which abut or encase the mesoportal vasculature. A decrease in the tumor-vessel interface could downsize pancreatic tumors, with the goal of increasing resection rates and post-resection local control. Citation Format: Margaret Lashof-Sullivan, Leslie S. Sloan, Michael P. Kim, Laura Indolfi, Ching-Wei D. Tzeng. Development of a novel implantable drug-eluting product for the local treatment of pancreatic adenocarcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2393.