Efficacy

Pivotal Trials-IGF-I Efficacy

SOMAVERT reduced IGF-I levels^1,3

In the 12-week fixed-dose pivotal trial…

SOMAVERT normalized IGF-I levels compared to placebo at each dose^1,3

The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.

Study Description: Data from a randomized, double-blind, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 subjects with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy. Total score for signs and symptoms are based on scores for 5 symptoms, each graded in severity from 0 (absent) to 8 (worst). Thus, the total possible score ranged from 0 to 40. The 5 symptoms graded were fatigue, excessive perspiration, headache, arthralgia, and soft-tissue swelling. The mean change from baseline for each dose was calculated averaging the change in total score at 12 weeks across all patients in that dosing arm. Mean baseline total score for signs and symptoms in all dose groups combined was 15.2.

Additional data from the 12-week fixed-dose pivotal trial...

75% of the total mean reduction in IGF-I levels occurred within 2 weeks, and the reduction was sustained over the 12-week course of therapy with all 3 doses^1,3

The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.

Study Description: Data from the randomized, double-blind, multicenter, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, 20 mg), study in 112 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy¹

Signs and Symptoms

In the same 12-week trial...

SOMAVERT demonstrated clinically significant improvement in total signs and symptoms score at each dose.¹

Total score for signs and symptoms was based on scores for 5 symptoms, each graded in severity from 0 (absent) to 8 (worst). Thus, the total possible score ranged from 0-40. The 5 symptoms graded were fatigue, excessive perspiration, headache, arthralgia, and soft-tissue swelling. The mean change from baseline for each dose was calculated based on the change in total score at 12 weeks across all patients in that dosing arm. Mean baseline total score for signs and symptoms (among subjects) in all dose groups combined was 15.2.

At 12 weeks, mean % change from baseline increased (worsened) 16% for placebo, and decreased (improved) 8% for 10 mg, 20% for 15 mg, and 33% for 20 mg

Study Description: In a post-hoc analysis, of the 57 patients who reached a normal IGF-I level and had at least 1 sign or symptom of acromegaly at the time of normalization, 91% (52 out of 57 patients) reported improvement in these signs and symptoms at the time of normalization or thereafter.⁶

IGF-I Normalization – Long Term

SOMAVERT provides established long-term IGF-I normalization in patients with acromegaly⁶

In an open-label extension to the clinical study...

SOMAVERT normalized IGF-I levels¹

Study Description: An open-label extension to the 12-week pivotal clinical study included 109 subjects (including 6 new patients) with mean treatment exposure of 42.6 weeks (range, 1 day–82 weeks). A total of 100 (92.6%) of the 108 subjects with available IGF-I data had a normal IGF-I concentration at any visit during the study.¹

IGF-I Normalization – Pretreated Patients

SOMAVERT—IGF-I normalization in patients with acromegaly previously treated with octeotide LAR⁷

It is important to identify and treat patients who have IGF-I levels above the age-adjusted normal range.

In a multicenter, open-label, 32-week trial…

SOMAVERT normalized IGF-I levels in 78% of patients previously treated with octreotide long-acting release (LAR)¹

Study Description: Adapted from Barkan et al. Results from a multicenter, open-label, 32-week trial (N=53) involving patients with acromegaly previously treated with octreotide LAR for a median of 562 days (range: 107-1336 days). Changes in IGF-I levels, glycemic control, liver function, and tumor size were monitored. SOMAVERT (10 mg/day) was initiated 4 weeks (baseline) after the last dose of octreotide LAR, at which time 29% of patients had IGF-I concentrations within the normal range and 71% of patients had elevated IGF-I concentrations. The dose of SOMAVERT was adjusted based on IGF-I concentrations at weeks 12, 20, and 28.⁷

*Signs and symptoms included headache, fatigue, athralgia, soft-tissue swelling, and excessive perspiration.

Study Description: Data from a randomized, double-blind, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 subjects with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy.Total score for signs and symptoms are based on scores for 5 symptoms, each graded in severity from 0 (absent) to 8 (worst). Thus, the total possible score ranged from 0 to 40. The 5 symptoms graded were fatigue, excessive perspiration, headache, arthralgia, and soft-tissue swelling. The mean change from baseline for each dose was calculated averaging the change in total score at 12 weeks across all patients in that dosing arm. Mean baseline total score for signs and symptoms in all dose groups combined was 15.2.")

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