Lung Cancer

SUBA-Itraconazole Lung


Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer-related deaths in the U.S., responsible for about 160,000 deaths a year—more than colon, breast & prostate cancer combined. Patients with late-stage non-small cell lung cancer (NSCLC), a cancer most often caused by cigarette smoking, have many options when considering therapies to extend survival. However, as reported by numerous scientific publications over the last few years, only approximately 50% of patients with advanced, non-squamous NSCLC are candidates for targeted chemotherapy (tyrosine kinase inhibitor) drugs or immunotherapy. The remaining 45,000 men and women with late-stage disease most often are treated with chemotherapy if they are not eligible for those other therapies. With a median survival of less than 10 months while on approved chemotherapy regimens, there is a significant unmet need in these patients with late-stage disease to slow progression and improve overall survival.

Itraconazole in Non-Small Cell Lung Cancer

Published human data support the use of itraconazole to address an unmet need for approximately half of patients with non-squamous NSCLC who are not candidates for immunotherapy or tyrosine kinase inhibitors. A randomized physician-sponsored Phase 2 study at a major U.S. university demonstrated that itraconazole, given in combination with chemotherapy, significantly improved median overall survival from eight months to 32 months.


Clinical plan


INHIBITOR plans to initiate a clinical program to evaluate SUBA-Itraconazole dosed in combination with second-line chemotherapy therapy to delay disease progression in patients with late-stage non-squamous NSCLC. If the regimen shows a progression-free survival benefit in these patients, SUBA-Itraconazole may qualify for one or more FDA accelerated programs, such as a breakthrough therapy or fast track status. The program is expected to benefit from existing human safety data and the 505(b)(2) regulatory pathway, similar to the Company’s program in prostate cancer. INHIBITOR anticipates filing a request for a pre-IND meeting with FDA by year-end 2022 to discuss the clinical testing plan for a Phase 2b study of SUBA-Itraconazole Lung.