DOSE REDUCTIONS

Dose reductions with KISQALI mean no need for new mid-cycle prescriptions or additional costs

For patients with stage II/III HR+/HER2- eBC at high risk of recurrence,

• KISQALI is given as 400 mg (2 x 200-mg tablets) orally, once daily (3 weeks on, 1 week off) for 36 months with an AI¹

  • Review the full Prescribing Information for recommended dosing of selected AI

  • An LHRH agonist should be used concomitantly with AI in men and premenopausal women

• Dose adjustments for adverse reactions should be made by reducing the number of tablets taken¹

  • If dose reduction below 200 mg/day is required, discontinue treatment

  • KISQALI dose modification is recommended based on individual safety and tolerability

  • KISQALI can be taken with or without food

Lowering the dose of KISQALI can help address side effects and, in the NATALEE trial, did not impact efficacy.^1,2

• iDFS was similar irrespective of the relative dose intensity (RDI) of KISQALI: Patients with low (0% to <82.27%), medium (82.27% to <97.44%), and high (≥97.44%) RDI had similar iDFS outcomes (low vs high HR=0.93 [95% CI: 0.69-1.25]; medium vs high HR=0.99 [95% CI: 0.74-1.32])²

• Results are based on a post hoc exploratory analysis. There was no prespecified statistical procedure controlling for type 1 error, and the results should be interpreted with caution

NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC, including all those with node-positive or high-risk node-negative disease (eligible stages and nodal status include: anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing). At a median follow-up of 33.3 months, with 509 iDFS (primary end point) events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892).^1,3,4

AI, aromatase inhibitor; eBC, early breast cancer; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; iDFS, invasive disease-free survival; LHRH, luteinizing hormone-releasing hormone; NSAI, nonsteroidal aromatase inhibitor.

DOSE ADJUSTMENT GUIDANCE

Dose adjustment guidance in HR+/HER2- eBC¹