Novartis AG Trial Stopped Early on Positive Data, Gets Ready to Take on Pfizer's Ibrance

Published: May 31, 2016

Novartis Trial Stopped Early on Positive Data, Gets Ready to Take on Pfizer (PFE)'s Ibrance May 19, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Basel, Switzerland — Novartis announced today that an independent Data Monitoring Committee recommended an early halt to a Phase III trial due to clinically meaningful improvement.

The MONALEESA-2 trial was evaluating LEE011 (ribociclib), a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, for advanced breast cancer. It was specifically evaluating postmenopausal women with no prior therapy for HR+/HER2- breast cancer. The trial was conducted at 294 sites worldwide with 668 patients. Half received the combination, the other hand just letrozole.

“We are excited that these results validate our belief that LEE011 in combination with letrozole can be a beneficial treatment option for women diagnosed with HR+/HER2- advanced breast cancer,” said Alessandro Riva, global head, Oncology Development and Medical Affairs, Novartis Oncology , in a statement. “Novartis is dedicated to continuing to discover and develop innovative targeted therapies that help improve and extend the lives of women living with this disease.”

The primary endpoint was progression-free survival. No data was announced, although analysts are eager to make a comparison of the drug to Pfizer ’s Ibrance. Seeking Alpha says, “However, this does set up a situation in which two big pharma will be in direct competition with each other in a space that Leerink analysts reckon will be worth $10 billion in 2025.”

Ibrance was given a projection of $5.3 billion in 2022 by EvaluatePharma.

Another drug in the same category, is Eli Lilly and Company ’s ebameciclib. That drug received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in October 2015. Novartis’ drug, if the timeline continues as expected, would likely beat Merck ’s drug to market.

Mark Belsey, an analyst with UBS, believes LEE011 could hit peak annual sales of $2.5 billion if it launches in 2018.

It was only two days ago that Novartis announced that it was splitting its pharmaceuticals business into two separate units. One will focus on oncology, and the other will focus on other drugs. At the same time, David Epstein, the American head of Novartis Pharmaceuticals , is leaving the company. He was high on the list of people expected to replace Andrew Witty as GlaxoSmithKline 's chief executive officer next year. Novartis has indicated Epstein is going to “explore new challenges from the U.S.,” which suggests he is not planning to move to GSK in the UK.

Novartis’ drug units account for about two-thirds of its $49 billion in annual sales. Last year, Novartis bought GSK’s marketed cancer drugs for $16 billion.

“Novartis expects this change to help drive our growth and innovation strategy, with an increased focus and improved execution,” Novartis said in a statement. “The new structure reflects the importance of oncology to Novartis following the successful integration of the oncology assets acquired from GlaxoSmithKline.”

Novartis is continuing to assess overall survival data from the MONALEESA-2 trial, and is discussing regulatory filings. It is also working to expand access programs in some areas to help women have access to LEE011.

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