September 2013 | Volume 12 | Issue 9 | Feature | 1065 | Copyright © 2013
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Novartis and Secukinumab (AIN457)
Novartis has announced results from the head-to-head Phase III psoriasis study which showed the superiority of secukinumab (AIN457) in clearing skin to Enbrel®* (etanercept), an anti-tumor necrosis factor (anti-TNF) therapy. In addition, secukinumab (AIN457) met all primary and secondary endpoints.
The FIXTURE trial (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized, double-blind, double-dummy, placebo-controlled, multicenter global study of subcutaneous secukinumab (AIN457) in moderate-to-severe plaque psoriasis involving 1,307 patients. It was designed to demonstrate efficacy after 12 weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to 52 weeks. Established treatment measures were used to assess the efficacy of secukinumab (AIN457) including PASI 75 (Psoriasis Area and Severity Index 75) and the Investigator’s Global Assessment (IGA mod 2011).
The secukinumab (AIN457) Phase III clinical trial program involved more than 3,300 patients in over 35 countries on five continents. Primary endpoints for four studies related to PASI 75 and IGA (IGA mod 2011) and the fifth study evaluated the proportion of patients who maintained PASI 75 after having achieved PASI 75 after 12 weeks of active treatment. The studies evaluated 150 mg and 300 mg doses of secukinumab (AIN457).
Promius® Introduces ZenataneTM
Promius Pharma LLC, has announced the introduction of ZenataneTM (Isotretinoin) Capsules, a newly approved isotretinoin option for patients with severe, recalcitrant, nodular acne. Zenatane, an AB rated equivalent to Accutane®, will be supported by The Promius Promise, a pharmacy service designed specifically to support Zenatane prescribers and patients. The program may help improve patient and physician experiences by increasing educational support and reducing patient out of pocket expenses. Promius Pharma has partnered with an accredited, iPLEDGE™-certified, US-based pharmacy to power The Promius Promise. The program is designed to assist with patient education about treatment requirements and deliver Zenatane within 24 hours to US locations, at a reduced, if not zero, out of pocket expense, for eligible patients.
GSK and Dabrafenib/Trametinib Combination in Metastatic Melanoma
GlaxoSmithKline (GSK) has announced submission of supplemental New Drug Applications (NDAs) to the FDA for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor. Supplemental applications were submitted to each of the currently approved NDAs for the use of each drug in combination with the other, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
The applications are based on data from a randomized Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600E and V600K mutation positive metastatic melanoma.
Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. European review of the submission for trametinib, both as monotherapy and in combination with dabrafenib, is ongoing.
Ipilimumab and Advanced Melanoma
Clinical Cancer Research has published a study report authored by Jeffrey S. Weber, Moffitt Cancer Center, et al. of a retrospective analysis conducted to characterize ipilimumab exposure–response relationships for measures of efficacy and safety in patients with advanced melanoma.
Data were pooled from 498 patients who received ipilimumab monotherapy at 0.3, 3, or 10 mg/kg in 1 of 4 completed phase II clinical trials. The relationships between steady–state ipilimumab trough concentration (Cminss), complete or partial tumor response (CR or PR), and safety [immune-related adverse events (irAEs)] were described by logistic regression models. The relationship between exposure and overall survival was characterized using a Cox proportional–hazards model.
The steady-state trough concentration of ipilimumab was found to be a significant predictor of a CR or PR (P < 0.001). Modelbased estimates indicate that the probabilities of a CR or PR at median Cminss for the 0.3, 3, and 10 mg/kg groups were 0.6%, 4.9%, and 11.6%, respectively. Overall survival at the median Cminss for ipilimumab at 0.3 mg/kg was estimated to be 0.85-