Clinical Studies

Clinical Studies

One open-label, multicenter study was conducted with each ELIGARD® formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A through D prostate cancer who were treated with at least a single injection of study drug (see table below).

1. Two patients withdrew for reasons unrelated to drug.
2. One patient received less than a full dose at Baseline, never suppressed, and was withdrawn at Day 73 and given an alternate treatment.
3. All non-evaluable patients who attained castration by Day 28 maintained castration at each timepoint up to and including the time of withdrawal.
4. One patient withdrew on Day 14. All 7 non-evaluable patients who had achieved castration by Day 28 maintained castration at each timepoint, up to and including the time of withdrawal.
5. Two patients were withdrawn prior to the Month 1 blood draw. One patient did not achieve castration and was withdrawn on Day 85. All 5 non-evaluable patients who attained castration by Day 28, maintained castration at each timepoint up to and including the time of withdrawal.

These studies evaluated the achievement and maintenance of serum testosterone suppression to castration levels over the duration of therapy (Figures 1-4).

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Breakthrough

During the AGL9904 study using ELIGARD 7.5 mg, once testosterone suppression was achieved, no patients (0%) demonstrated breakthrough (concentration > 50 ng/dL) at any time in the study.

During the AGL9909 study using ELIGARD 22.5 mg, once testosterone suppression was achieved, only one patient (< 1%) demonstrated breakthrough following the initial injection; that patient remained below the castrate threshold following the second injection.

During the AGL0001 study using ELIGARD 30 mg, once testosterone suppression was achieved, three patients (3%) demonstrated breakthrough:

Patient 1

• 53 ng/dL single serum testosterone concentration: day after second injection
• Castrate suppression was reported for all other time points.

Patient 2

• 66 ng/dL serum testosterone concentration immediately prior to second injection
• 147 ng/dL second day after second injection; maximum concentration
• Suppression to castration levels was again reached on the seventh day after the second injection and was maintained thereafter.

Patient 3

• >50 ng/dL serum testosterone concentrations: two and at eight hours after the second injection.
• 110 ng/dL third day after the second injection; maximum concentration
• Suppression to castration levels was again reached eighteen days after the second injection and was maintained until the final day of the study, when a single serum testosterone concentration of 55 ng/dL was reported.

During the AGL0205 study using ELIGARD 45 mg, once testosterone suppression was achieved, one patient (<1%) demonstrated breakthrough. Patient reached suppression to castration levels at Day 21 and remained suppressed until Day 308 when his testosterone level rose to 112 ng/dL. At Month 12 (Day 336), his testosterone was 210 ng/dL.

Serum PSA decreased in all patients in all studies whose Baseline values were elevated above the normal limit. Refer to the table below for a summary of the effectiveness of ELIGARD® in reducing serum PSA values.

1. *Among patients who presented with elevated levels at Baseline

Other endpoints

Other secondary efficacy endpoints evaluated included WHO performance status, bone pain, urinary pain, and urinary signs and symptoms. Refer to the table below for a summary of these endpoints.

1. WHO Status = 0 classified as “fully active.”
2. WHO Status = 1 classified as “restricted in strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.”
3. WHO Status = 2 classified as “ambulatory but unable to carry out work activities.”
4. Pain score scale: 1 (no pain) to 10 (worst pain possible).