Oral recombinant human Lactoferrin (rhLF) slows tumor growth in metastatic NSCLC and other advanced incurable cancers: Results of a Phase II study

Abstract

3140 Background: RhLF, a novel immunomodulatory agent, was previously shown to have anti-tumor activity in a variety of animal models, and was safe and well tolerated in Phase I human trials. Methods: 33 patients with advanced solid tumors that had progressed on previous chemotherapy regimens, or who had no effective chemotherapy regimens available, will be scheduled to receive oral rhLF monotherapy in cycles of 2 weeks on, 2 weeks off, until tumor progression. Following an initial dose escalation, patients were randomized between the two highest rhLF doses (4.5 or 9 g/day). Tumor response was followed by periodic CT scans using RECIST criteria. Results: We have enrolled 27 patients to date–9 with NSCLC, 4 each with renal and colon cancer, and 3 or fewer with seven other tumor types. RhLF was safe and well tolerated, with no drug-related SAEs or DLTs. A total of 22 patients were evaluable radiologically. We observed one (5%) partial response and 12 (55%) stable disease. In NSCLC patients, the largest group, 5 patients (53%) had stable disease. In patients with renal cancer, we had one (25%) partial response and 3 (75%) stable disease. Colon cancer patients had 50% stable disease. We also observed a substantial decrease in the growth rate of target lesions before and after start of rhLF. The average tumor growth rate dropped by 68% (p<0.05) from 5.2% to 1.7% per week. A reduction in tumor growth rate could potentially result in increased survival. The NSCLC patients (88% tumor rate reduction; p<0.05) already appear to demonstrate a survival benefit. The median survival to date among the 9 NSCLC patients is 8 months (with only one death), which compares favorably to the 4.6 months expected median for pretreated patients with metastatic lung cancer. Updated survival and response data will be presented. Conclusions: RhLF is safe and well tolerated, shows promise in salvage therapy of NSCLC and renal cancer, and should be evaluated in larger Phase II trials. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Agennix, Inc. Agennix, Incorporated