Prescribing information



Postmenopausal women (first line in combination with AI)

It’s time to let them expect more from treatment than ever before.

KISQALI + letrozole has delivered what no other CDK4/6i did – the longest statistically significant median overall survival ever reported in HR+/HER2− aBC1–42


MONALEESA-2 primary endpoint: PFS.

In the primary analysis ITT population, mPFS was 25.3 months in the KISQALI + letrozole arm vs 16.0 months in the placebo + letrozole arm, HR 0.57 (95% CI: 0.46–0.70), p<0.0001.23


MONALEESA-2 Key secondary endpoint: OS

Significantly more life at a median follow-up of 80 months1

Kaplan-Meier graph showing overall survival per investigator assessment for KISQALI + letrozole or placebo.

Adapted from Hortobagyi GN, et al. 2022.1


Your 1L treatment choice is clear, with median overall survival over 5 years for postmenopausal women with HR+/HER2− advanced breast cancer.1


MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomisation, multicentre, phase III trial in postmenopausal women with HR+/HER2− aBC. As 1L in advanced disease. No prior endocrine therapy for aBC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).43 The primary endpoint was locally assessed progression-free survival, and the key secondary endpoint was overall survival. Other secondary endpoints included the overall response rate (complete or partial response), the clinical benefit rate (overall response plus stable disease lasting 24 weeks or more), safety, and quality-of-life assessments.43

The overall survival benefit with KISQALI + AI increased over time1

MONALEESA-2: At 6 years, the survival rate of patients receiving KISQALI + AI was 44.2%1

Graph showing survival rates at 4, 5, and 6 years with KISQALI or placebo + AI in all patients with measurable disease in MONALEESA-2.

Adapted from Hortobagyi GN, et al. 2022.1

MONALEESA-2: Subsequent CDK4/6i use was higher in the placebo arm (34.4%) than the KISQALI arm (21.7%)1

Table showing subsequent therapy after discontinuation

Adapted from Hortobagyi GN, et al. 2022.1

* Percentages reported are based on the number of patients who discontinued study treatment.
† Two patients (0.6%) in the KISQALI arm and 4 patients (1.2%) in the placebo arm received other therapies as the first subsequent antineoplastic therapy.
‡ A patient with multiple occurrences of receiving a subsequent CDK4/6i is only counted once for the total row.


MONALEESA-2: KISQALI delayed time to first chemotherapy by approximately 1 year1

Graph showing delayed time to chemotherapy over a year

Adapted from Hortobagyi GN, et al. 2021.1,45

Time to first chemotherapy was defined as the time from randomisation to the start of the first chemotherapy following discontinuation of the study treatment.

KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.* In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.44

* KISQALI is not recommended to be used in combination with tamoxifen.44


1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; CT, chemotherapy; ER, estrogen receptor; HR, hazard ratio; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; ITT, intention to treat; KM, kaplan-meier; mOS, median overall survival; mPFS, median progression-free survival.

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UK | September 2022 | 149408-3

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