CDK4/6 smokes again!

On September 19, Novartis announced that it is cooperating with the SOLTI Innovative Cancer Research Center and plans to carry out a phase III study code-named Harmonia.
HER2E) HR+/HER2-The difference in the treatment effect of advanced breast cancer
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HER2E refers to the presence of HER2 gene amplification but no enhancement of HER2 protein-mediated signal activity at the transcription level
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The Harmonia study is the first prospective phase III trial to recruit patients with specific tumor molecular subtypes at the RNA level, and it is also the first clinical trial to conduct a head-to-head comparison of CDK4/6 inhibitors in patients with HR+/HER2-advanced breast cancer
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The reason why Novartis launched this head-to-head comparison is mainly because its competitor Ibrance has a first-mover advantage to occupy more than 70% of the market share in the CDK4/6 track, although Kisqali is the only one in three key clinical studies (MONALEESA).
-7, MONALEESA-3, MONALEESA-2) proved that compared with endocrine therapy alone, CDK4/6 inhibitors have an OS benefit advantage in patients with HR+/HER2- advanced breast cancer, but they did not reverse the suppression of Ibrance in the market Situation
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Although Ibrance's sales revenue continued to slow, and even lost the US market in the first two quarters of 2021, it was mainly hit by Eli Lilly and Verzenio (Abecili)
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Kisqali seems to be inferior to Verzenio in terms of momentum, but the CDK4/6 track tri-final battle for hegemony may intensify
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This may be the consideration behind Novartis’s plan to carry out the Harmonia study.

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