- Novartis’ phase 3 trial of its breast cancer drug ribociclib was stopped early by an independent data monitoring panel due to positive results, the company said Wednesday.
- In the trial, advanced breast cancer patients treated with ribociclib (also known as LEE011) in combination with letrozole significantly increased progression free survival, compared to letrozole alone.
- Similar to Pfizer’s Ibrance, ribociclib is a cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor. The positive results could set up Novartis to compete with Pfizer and follows the company’s announcement it would separate its oncology business from its drugs division.
When Pfizer's Ibrance was approved in February 2015, analysts pegged it as a blockbuster-in-the-making, with a potential $4 billion in sales by 2020. Now that Novartis is coming close to gaining approval for its CDK 4/6 inhibitor, analysts have become even more enthusiastic about the prospects for the breast cancer market as a whole.
Evaluate Pharma sees Ibrance staying in the lead for some time and forecasts $5.3 billion in global revenues by 2022. And if Lilly's development plans with abemaciclib come to fruition, Pfizer and Novartis could face additional competition. All of this is good news for patients, as combo therapies have shown greater efficacy in treating breast cancer.
Novartis did not provide any numeric results in its news releases. Researchers are continuing to evaluate overall survival data, and will also focus on continued development of ribociclib through different trials in the Monaleesa program.
Ribociclib is being evaluated in combination with fulvestrant in men and postmenopausal women with breast cancer, as well as in combination with endocrine therapy and gosrelin.