NDA submitted for 3-month formulation of leuprolide mesylate for advanced prostate cancer

Foresee Pharmaceuticals has submitted a new drug application (NDA) to the FDA seeking approval of a 3-month depot formulation of leuprolide mesylate injection (Camcevi) for patients with advanced prostate cancer, the company announced in a news release.¹

A 6-month formulation of leuprolide was previously approved by the FDA in May 2021.

A 6-month formulation of leuprolide was previously approved by the FDA in May 2021,² followed by a US market launch of the drug in April 2022. The 6-month formulation is also currently 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, in the news release.¹ “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.”

The NDA submission is supported by data from an open-label, single-arm, phase 3 trial (NCT03261999) of leuprolide mesylate administered as 2 injections, 3 months apart in patients with advanced prostate cancer. Overall, the study met its primary end point with 97.9% of patients achieving a serum testosterone concentration suppression to castrate levels (≤ 50 ng/dL) from day 28 through day 168.³

At the day 28 timepoint, the suppression rate was 98.6% (141/143) among patients in the intent-to-treat population. The mean testosterone concentration was suppressed to 17.8 ng/dL, below castrate levels. There was no reported mean increase in testosterone following the second injection.

Regarding safety, there were a total of 217 treatment-emergent adverse events (TEAEs) reported among 90 patients. Of those, 165 TEAEs were grade 1, and 43 TEAEs were grade 2. Severe TEAEs were reported in 7 patients. The most common adverse events in the study were hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).

In total, the study enrolled 144 adult patients with advanced prostate cancer who received at least 1 dose of 25 mg leuprolide injection. Of these, 132 patients received a second dose of the drug twelve weeks following the first injection.

Patients were enrolled in the study throughout 21 clinical trial sites across the United States, Europe, and Asia.⁴

Participants were eligible for enrollment if they had a baseline morning serum testosterone level greater than 150 ng/dL at the time of screening, an ECOG performance score of 2 or below, and a life expectancy of at least 18 months. Patients also needed to be candidates for androgen ablation therapy, per the judgment of the attending physician or principal investigator.

The primary end point for the study was the percentage of patients who achieved suppression of serum testosterone to castrate levels (≤ 50 ng/dL) at day 28 and from day 28 through day 168. The study’s secondary end points were safety and tolerability.

Patients in the study were followed for up to 168 days.

References

1. Foresee Pharmaceuticals announces submission of the NDA to the U.S. FDA for the 3-month version of CAMCEVI for the treatment of advanced prostate cancer. News release. Foresee Pharmaceuticals Co, Ltd. October 29, 2024. Accessed October 30, 2024. https://www.foreseepharma.com/en-us/news/1/362

2. Foresee Pharmaceuticals announces FDA approval of CAMCEVI for the treatment of advanced prostate cancer; Accord BioPharma to head the U.S. commercialization. News release. Foresee Pharmaceuticals. May 26, 2021. Accessed October 30, 2024. https://www.foreseepharma.com/en-us/news/1/340

3. Foresee Pharmaceuticals announces successful topline results from phase 3 registration study of LMIS 25 mg in prostate cancer. News release. Foresee Pharmaceuticals Co, Ltd. February 21, 2019. Accessed October 30, 2024. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-successful-topline-results-from-phase-3-registration-study-of-lmis-25-mg-in-prostate-cancer-300799580.html

4. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinicalTrials.gov. Last updated May 4, 2020. Accessed October 30, 2024. https://clinicaltrials.gov/study/NCT03261999