Foresee Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ready-to-use, 3-month depot formulation of leuprolide mesylate (Camcevi) for the palliative treatment of patients with advanced prostate cancer. The submission is based on positive data from a phase 3 clinical trial, potentially offering a new option for patients requiring androgen ablation therapy.
Phase 3 Trial Results
The NDA is supported by data from an open-label, single-arm phase 3 trial (NCT03261999) that evaluated the efficacy and safety of leuprolide mesylate in suppressing serum testosterone levels. The study demonstrated that 97.9% (95% CI, 93.5%-99.3%) of patients treated with leuprolide mesylate achieved suppression of serum testosterone to no more than 50 ng/dL by day 28 and maintained this suppression from day 28 to day 168 in the intention-to-treat population (n = 144).
On day 28, the mean testosterone concentration was 17.8 ng/dL, with a suppression rate of 98.6% in evaluable patients (n = 143). Following the second injection of leuprolide mesylate, no mean increase in testosterone was observed. Of the 3 patients who did not meet the primary endpoint, 2 did not achieve the required castration level on day 28, and 1 patient experienced transient testosterone escape following the second injection.
Safety Profile
The phase 3 trial also assessed the safety of leuprolide mesylate. Ninety patients experienced a total of 217 treatment-emergent adverse effects (TEAEs). The majority of TEAEs were grade 1 (165 TEAEs in 79 patients) or grade 2 (43 TEAEs in 28 patients). Nine severe TEAEs occurred in 7 patients. The most common adverse events reported in more than 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).
Expanding Treatment Options
"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."
Trial Design and Patient Population
The phase 3 trial enrolled patients at least 18 years of age with histologically confirmed carcinoma of the prostate who were candidates for androgen ablation therapy. Key inclusion criteria included a baseline serum testosterone level of more than 150 ng/dL, an ECOG performance status of 0 to 2, a life expectancy of at least 18 months, and adequate laboratory values. Patients received leuprolide mesylate at 25 mg on day 0, followed by a second dose on day 84, and were followed until day 168.
