Ready-to-Use 3-Month Leuprolide Depot Formulation Nears FDA Approval

• A new drug application (NDA) for a 3-month depot formulation of leuprolide mesylate (Camcevi) has been submitted to the FDA, aiming to offer a ready-to-use palliative treatment for advanced prostate cancer.
• In an open-label, single-arm, phase 3 trial (NCT03261999), 97.9% of trial patients achieved target testosterone suppression through day 168.
• Approval is expected in 2025 with a 2026 market release.

A 502(b)(2) NDA has been submitted to the FDA for the approval of a ready-to-use, 3-month depot formulation of leuprolide mesylate designed for the palliative treatment of patients with advanced prostate cancer.¹

Findings from a phase 3 trial back this submission. Here, 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 end point was met by nearly all patients in the intention-to-treat group (n = 144).²

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 end point, 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.

3D rendered medically accurate illustration of prostate cancer: © SciePro - stock.adobe.com

"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, in a 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.”

About the Phase 3 Trial

In the open-label, single-arm, phase 3 trial, patients aged 18 years and older with histologically confirmed carcinoma of the prostate who were deemed candidates for androgen ablation therapy were enrolled.³ Enrollment was also open to those 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. Alongside testosterone suppression as the primary end point of the study, safety was a secondary end point.

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%).

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. October 30, 2024. Accessed October 30, 2024. https://tinyurl.com/uu699wmp

2. Foresee Pharmaceuticals announces successful topline results from phase 3 registration study of LMIS 25 mg in prostate cancer. News release. Foresee Pharmaceuticals. February 21, 2019. Accessed October 30, 2024. https://tinyurl.com/3kxerr8e

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