7th heaven.

Headline: There’s more data to support CDK4/6 inhibition. In MONALEESA-7, yes 7, pre- or peri-menopausal women (up to age 59) receiving goserelin plus an AI or tamoxifen for advanced ER(+) HER2(-) breast cancer were randomized to the addition of placebo versus ribociclib. The big news here is the interim analysis reports a significant improvement in overall survival with ribociclib from 46 → 70% at 42 months. That’s big news because it’s the first CDK4/6 inhibitor to improve overall survival. An important caveat is that this trial included a much more specific population that the PALOMA trials that showed a survival benefit only in a subset. Or is that just a better design… What’s more, the survival benefit in MONALEESA-7 was maintained across subsets including those receiving AI or tamoxifen. TBL: In pre- or peri-menopausal women with advanced ER(+) HER2(-) breast cancer, the addition of ribociclib to initial endocrine therapy improves overall survival. | Im, N Engl J Med 2019