VIVUS, Inc. announces the publication of new clinical trial data demonstrating that PANCREAZE® (pancrelipase) helped to stabilize weight in patients undergoing chemotherapy for the treatment of pancreatic ductal adenocarcinoma (PDAC) who have cachexia (wasting syndrome) and exocrine pancreatic insufficiency (EPI). The data also suggest that PANCREAZE may reduce stool frequency and improve stool consistency. Researchers at Cedars-Sinai Medical Center and the Samuel Oschin Cancer Center conducted the investigator-initiated trial.

VIVUS provided PANCREAZE and funding to support the clinical trial. PANCREAZE is approved in the United States and Canada for the treatment of EPI due to cystic fibrosis or other conditions. The data was published in an ePoster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL and online.

The poster published at ASCO (Abstract # e24059) describes the results of single-site phase 2 trial (NCT0409823) for pancreatic-enzyme replacement therapy (PERT) with PANCREAZE plus standard of care (SOC) chemotherapy in PDAC patients with cachexia and EPI. The primary outcome measure was to assess feasibility of completing PERT during the first 8 weeks of treatment. Feasibility was defined as adherence to therapy of =50% of the needed total lipase units in the first 8 weeks of treatment (84,000 IU lipase units per meal, 42,000 IU lipase units per snack).

Secondary outcome measures included weight stability, mean change in stool frequency, stool consistency from Cycle 1 (C1) to Cycle 3 (C3) (after 8 weeks of PERT), mean change in serum levels of fat-soluble vitamins (A, D, E, K) from baseline to end of study, functional activity, and safety. The study enrolled 36 patients, of whom 30 were evaluable for the primary endpoint. Key findings from the 30 evaluable patients include: The adherence rate was 96.7% (29/30).

Weight remained stable (-0.01±0.07 kg/BMI, p=0.511). There was a trend toward reduced stool frequency (p=0.052) from C1 to C3. Stool consistency from C1 to C3 showed significant association (p=0.035).

No significant differences were observed from C1 to C3 in serum fat soluble vitamins, functional activity by walk speed and hand grip strength. There were no Grade 3/4 adverse events associated with PANCREAZE.