Foresee Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its 3-month depot formulation of leuprolide mesylate injection (Camcevi) for the palliative treatment of patients with advanced prostate cancer. This submission marks a significant step in expanding treatment options for this patient population.
The NDA is based on data from a Phase 3 open-label, single-arm clinical trial (NCT03261999) in which patients with advanced prostate cancer received two injections of leuprolide mesylate, three months apart. The study met its primary endpoint, demonstrating that 97.9% of patients achieved suppression of serum testosterone concentration to castrate levels (≤ 50 ng/dL) from day 28 through day 168.
Efficacy and Safety Data
The Phase 3 trial enrolled 144 adult patients with advanced prostate cancer across 21 clinical trial sites in the United States, Europe, and Asia. Patients had to have a baseline morning serum testosterone level greater than 150 ng/dL, an ECOG performance score of 2 or below, and a life expectancy of at least 18 months. At day 28, the suppression rate was 98.6% (141/143) among patients in the intent-to-treat population, with a mean testosterone concentration suppressed to 17.8 ng/dL, well below castrate levels. No mean increase in testosterone was reported following the second injection.
Regarding safety, 217 treatment-emergent adverse events (TEAEs) were reported among 90 patients. The majority of these were grade 1 (165 TEAEs) or grade 2 (43 TEAEs). Severe TEAEs were reported in 7 patients. The most common adverse events included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).
Current Landscape and Future Prospects
Leuprolide mesylate is a gonadotropin-releasing hormone (GnRH) agonist used to suppress testosterone production in men with advanced prostate cancer. A 6-month formulation of leuprolide (Camcevi) was previously approved by the FDA in May 2021 and launched in the US market in April 2022. It is also approved for advanced prostate cancer in the EU, Canada, Taiwan, and Israel.
"Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI 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. The company anticipates potential FDA approval in 2025 and a commercial launch in 2026.
Foresee Pharmaceuticals focuses on developing long-acting injectable formulations using its Stabilized Injectable Formulation (SIF) technology, as well as developing first-in-class NCE programs for rare and severe diseases with unmet needs.
