A biologic + AI for early-stage BC?

ChiSandy

Just got this in my inbox from:

Abemaciclib active in early breast cancer

Abemaciclib (made by Lilly, no brand name announced yet) is a biologic CDK 4/6 inhibitor—the same class of drugs as palbociclib (Ibrance) and ribociclib (Kisqali)—that a new study has shown is—alone or in combination with anastrazole—more effective in suppressing Ki-67 expression and increasing beneficial T-cells in early-stage ER+/HER2- breast cancer in postmenopausal women. Ibrance & Kisqali are FDA-approved to treat Stage IV ER+/HER2- breast cancers (usually in combination with letrozole) in postmenopausal women. But abemaciclib is different in that it can be used in early stages of this type of b.c. in postmenopausal women—and unlike Ibrance & Kisqali, can be given continuously. The three weeks on/one week off dosing schedule (the “off week” being necessary for neutrophil recovery) for those two drugs is thought to allow a rebound in cell-cycling during the off-week that can develop into resistant tumor cells. Abemaciclib has less of a neutrophil-suppressant effect. Its most common side effects are diarrhea, nausea, fatigue, kidney dysfunction, red-and-white blood count reduction, anorexia and weight loss (might the latter two help mitigate AI-induced weight gain?); so in the study Imodium was given along with it to mitigate the diarrhea. Hair loss has not been reported.

Caveats:

• It is still an investigational drug, in clinical trials
• Ibrance and Kisqali are extremely expensive and not covered by many insurers—and not on the formularies of most Medicare Part D carriers; though there are co-pay cards and assistance programs, those with any form of Federalgovernment-subsidized drug coverage (Medicaid, Medicare Part D or “Advantage” plans, or Federal employee insurance that includes drug coverage) are ineligible to use these coupons & co-pay cards; assistance plans available to Federally-subsidized drug coverage-holders are few & far between and income-based; those who are more affluent but not wealthy would not be able to afford them; and since abemaciclib is even newer and not yet commercially available, when it goes on the market it would probably be every bit as, if not more expensive than, Ibrance & Kisqali.
• It is being studied only alone or in combo with anastrazole. No data are available for administering it with a different AI such as letrozole or exemestane.