Foresee Pharmaceuticals has announced that its new drug application (NDA) for a 3-month depot formulation of leuprolide mesylate (Camcevi) is under review by the FDA for the palliative treatment of advanced prostate cancer. This ready-to-use formulation aims to provide a more convenient option for patients requiring androgen ablation therapy.
The submission is supported by data from an open-label, single-arm, phase 3 trial (NCT03261999) in which 97.9% (95% CI, 93.5%-99.3%) of patients achieved serum testosterone suppression to no more than 50 ng/dL by day 28 and sustained this level through day 168. This primary endpoint was met by nearly all patients in the intention-to-treat group (n = 144).
Phase 3 Trial Details
The phase 3 trial enrolled patients aged 18 years and older with histologically confirmed carcinoma of the prostate who were candidates for androgen ablation therapy. The trial also included patients with a baseline serum testosterone level of more than 150 ng/dL, a life expectancy of at least 18 months, an ECOG performance status of 0 to 2, and adequate laboratory values.
The dosing protocol involved a 25-mg leuprolide mesylate injection on day 0, followed by a second dose on day 84, with patient follow-up extending to day 168. The primary endpoint was testosterone suppression, with safety as a secondary endpoint.
The trial revealed a mean testosterone level of 17.8 ng/dL on day 28, with a suppression rate of 98.6% in patients who were evaluable (n = 143). After the second injection, no average increase in testosterone was noted. Three patients did not reach the primary endpoint, 2 of whom also had not met the required castration level by day 28. Additionally, 1 patient had a brief testosterone spike after the second dose.
Safety Profile
Adverse events (AEs) were reported in 90 patients, with 217 treatment-emergent adverse effects (TEAEs) documented. Of these, 165 were grade 1 in 79 patients, while 43 were grade 2 events in 28 patients. Nine serious TEAEs were recorded across 7 patients. Common AEs, reported in over 5% of participants, included hot flashes (24.31%), hypertension (11.11%), weight gain (7.64%), and injection site bleeding (5.56%).
Company Statement
"Following the successful launch of [the leuprolide mesylate] 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of [leuprolide mesylate] NDA to the US FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer," said Ben Chien, PhD, founder and chairman of Foresee Pharmaceuticals. "We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile."
