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A phase II open-label trial of apomine (SR-45023A) in patients with refractory melanoma
Karl D Lewis1, John A Thompson, Jeffrey S Weber
1University of Colorado, Cancer Center, 1665 North Ursula St, Mail Stop F-703, Aurora, CO 80045, USA.
Abstract:
Metastatic melanoma continues to be a very difficult disease to treat. Options are limited and often have very little impact on the course of the disease. The objective of the current study was to evaluate the efficacy and safety of continuously administered Apomine (SR-45023A), a novel bisphosphonate, in patients with previously treated metastatic malignant melanoma. Adult patients with previously treated metastatic melanoma received Apomine 100 mg orally, twice daily (total dose 200 mg per day) continuously for 28 days (defined as a cycle). Treatment was continued until disease progression or unacceptable toxicity. A total of 42 patients received at least one dose of Apomine. Stable disease was achieved in 2 patients (5%). No complete or partial responses were observed. Progression free survival of at least 16 weeks was observed in 6 patients (14%). The median overall survival was 6.1 months (95% CI, 4.9-9.4 months). Time to treatment failure was 1.7 months (95% CI, 1.6-1.8 months) with Apomine therapy. By cycle 2, Apomine concentrations reached steady-state. Apomine was well tolerated with only 37% of patients experiencing any drug-related event. Abdominal pain was the most frequent adverse event occurring in 26% of patients. In conclusion, Apomine, at the current dose studied, failed to produce a 30% progression free survival rate at 16 weeks considered to be a meaningful benefit for further development.
Insights
Apomine, a novel bisphosphonate, showed limited efficacy in treating metastatic melanoma. The drug was generally well-tolerated but did not meet key progression-free survival goals for further development.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic melanoma presents significant treatment challenges with limited therapeutic options.
- Existing treatments for advanced melanoma often yield minimal impact on disease progression.
Purpose of the Study:
- To assess the efficacy and safety of continuously administered Apomine (SR-45023A), a novel bisphosphonate.
- To evaluate Apomine in patients with previously treated metastatic malignant melanoma.
Main Methods:
- Adult patients with metastatic melanoma received Apomine 200 mg daily continuously for 28-day cycles.
- Treatment continued until disease progression or unacceptable toxicity.
- Pharmacokinetic analysis showed Apomine reached steady-state by cycle 2.
Main Results:
- Of 42 patients, 5% achieved stable disease; no complete or partial responses were observed.
- 14% of patients achieved progression-free survival of at least 16 weeks.
- Median overall survival was 6.1 months; median time to treatment failure was 1.7 months.
Conclusions:
- Apomine demonstrated a favorable safety profile, with 37% experiencing drug-related events, most commonly abdominal pain.
- The study concluded that Apomine, at the tested dose, did not meet the 30% progression-free survival benchmark for meaningful development in metastatic melanoma.
