Somatuline's growing but the ELECT data show half patients fail on Somatuline and need sandostatin rescue. Somatuline did not met primary endpoint. Somatuline might have immunogenicity problem 10% neutralizing antibody which is not surprising being subQ drug.
Ipsen has been going around saying they are the same drug for years. The problem with Somatuline is that patients require rescue with Sando in their pivotal trial. THis was published already. http://meetinglibrary.asco.org/content/123139-143 Background: Somatostatin analogs (SSAs) are the mainstay treatment for carcinoid syndrome. LAN is a long-acting SSA approved for this indication in >50 countries, but not yet in the US. ELECT is a large multinational phase 3 study evaluating rescue therapy use as a novel alternate endpoint for carcinoid symptom control with LAN. Methods: Eligible patients were age ≥ 18 years with histologically-confirmed NET and a history of carcinoid syndrome, and naïve to SSA treatment or responsive to conventional doses of octreotide LAR (≤ 30 mg/4 weeks) or short acting (≤ 600 µg/day SC). Design: a 16-week, randomized (LAN 120 mg [n=59] vs placebo [n=56] every 4 weeks) double-blind phase, followed by a 32-week long-term open label phase on LAN. Patients had access to short acting octreotide as rescue for breakthrough symptoms throughout the study. Primary endpoint: % of days the patient used rescue octreotide during the double-blind phase. The study was designed to have 90% power to detect a treatment difference of 30%. NCT00774930. Results: Among thestudy population, 83 (72%) had symptoms for ≥ 1 year, and51 (44%)had no prior SSA therapy. Mean [95% CI] % of days with rescue medication use was statistically lower with LAN (34% [25, 42%]) vs placebo (49% [40, 57%]), absolute difference –15% [–27, –3%], p=0.02; however, the pre-defined difference was not met. Complete/partial success (≤3 days use) rather than failure (> 3 days use) was more likely with LAN than placebo (OR 2.4 [95% CI 1.1, 5.3]; p=0.04). Treatment emergent AEs: 15 (26%) LAN patients vs 11 (19%) placebo patients; few AEs were serious (2 [3%] vs 5 [9%]) or led to study withdrawal (1 [2%] vs 1 [2%]). Most frequent AEs were GI disorders, 9 (16%) on LAN vs 5 (9%) on placebo. Conclusions: In the ELECT study, LAN significantly reduced need for short acting SSA use with a favorable safety/tolerability profile. This confirms LAN’s positive benefit-risk profile, which is consistent with experience from previous trials and many years of clinical practice in many countries around the world. Clinical trial information: NCT00774930. need for short acting SSA use is the key statement. Somatuline still needs sando. Sando does not need somatuline. We need to step up and stop thier offlable promotion. not safe for patients
