Novartis Cardiovascular Drug Positive, NSCLC Drug Approved
Shares of Novartis AG NVS were up after the company announced positive top-line results from the global phase III study, CANTOS. The study evaluated the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in patients with a prior heart attack and inflammatory atherosclerosis.
In fact, shares touched a fresh 52-week high of $86.90 on the results. The study met the primary endpoint. The candidate demonstrated canakinumab when used in combination with standard of care reduced the risk of major adverse cardiovascular events (MACE). Novartis will present the full data later in 2017.
The positive results provided a boost to shareholders sentiments as its other cardiovascular candidate RLX030 (serelaxin) did not meet its primary endpoints.
Novartis also announced that the FDA has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients suffering from metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation.
The combination was granted Breakthrough Therapy designation in Jul 2015 for the treatment of advanced or metastatic BRAF V600E mutation-positive NSCLC patients who have received chemotherapy previously.
60% of treatment-naïve and previously treated patients with BRAF V600E mutant metastatic NSCLC responded to Tafinlar + Mekinist in a pivotal study.
We note that the Tafinlar + Mekinist combination was approved by the European Commission (EC) in Mar 2017 for the treatment of patients with BRAF V600 advanced mutation-positive NSCLC.
We remind investors that the combination of Tafinlar and Mekinist is already approved in the U.S. and EU for the treatment of patients with unresectable or MM who have a BRAF V600 mutation. Both Tafinlar and Mekinist are also approved individually as single agents for the treatment of patients with unresectable or metastatic melanoma.
Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s GSK certain oncology products and pipeline compounds in Mar 2015 after having divested its Animal Health Division to Eli Lilly and Co. LLY. Both Tafinlar and Mekinist were acquired from Glaxo.
Novartis also reported that ophthalmology candidate RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two phase III studies, HAWK and HARRIER. The studies enrolled more than 1,800 patients with neovascular age-related macular degeneration (nAMD) in the trials. The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to Regeneron Pharmaceuticals’s REGN Eylea in mean change in best-corrected visual acuity (BCVA) from baseline to week 48, and average mean change over the period of week 36-48, respectively.
Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
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