Efficacy of KISQALI® (ribociclib)

Is it time to make KISQALI your 1L CDK4/6i of choice for eligible HR+/HER2– aBC patients?¹

In HR+/HER2– aBC, KISQALI + ET is the only CDK4/6i with significant 1L OS benefit across 3 Phase III trials^3–5

KISQALI is not recommended to be used in combination with tamoxifen.¹

• MONALEESA-2: At 80-months follow-up, a significant OS benefit was observed, with a mOS of 63.9 months (95% CI: 52.4–71.0) with KISQALI + AI (n=334) and 51.4 months (95% CI: 47.2–59.7) with placebo + AI (HR for death, 0.76; 95% CI: 0.63–0.93; two-sided p=0.008)³

• MONALEESA-3: KISQALI + fulvestrant (n=484) showed a significant OS benefit over placebo + fulvestrant. The estimated OS at 42-month follow-up was 57.8% (95% CI: 52.0–63.2) in the KISQALI group and 45.9% (95% CI: 36.9–54.5) in the placebo group, (HR=0.72; 95% CI: 0.57–0.92; p=0.00455)⁶

• MONALEESA-7: The estimated OS at 42-month follow-up was 70.2% (95% CI: 63.5–76.0) in the KISQALI + ET group (n=335) and 46.0% (95% CI: 32.0–58.9) in the placebo + ET group (HR for death, 0.71; 95% CI: 0.54–0.95; p=0.00973 by log-rank test)⁷

Results are from individual studies. They are presented together for illustrative purposes only and should not be directly compared. Due to the exploratory nature of some of the analyses, the statistics are descriptive and need to be interpreted with caution.

MONALEESA-2

Primary endpoint PFS: (n=334) In the primary and updated analyses, mPFS was significantly longer with KISQALI + AI than with placebo + AI (updated analysis: 25.3 months vs 16.0 months, respectively; HR for disease progression or death=0.57; 95% CI: 0.46–0.70, p<0.001).^3,8

MONALEESA-3

Primary endpoint PFS: (n=484) KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with an mPFS of 20.5 months versus 12.8 months (HR=0.59; 95% CI: 0.48–0.73, p<0.001)⁹

Image

In an exploratory analysis, 1L KISQALI + fulvestrant was observed to demonstrate an increased OS rate vs fulvestrant + placebo in postmenopausal patients⁴

• Extended median follow-up of 71 months⁴

MONALEESA-7

Primary endpoint PFS: (n=335) KISQALI + ET (NSAI or tamoxifen plus goserelin) was associated with significant improvement in PFS versus placebo + ET (NSAI or tamoxifen plus goserelin), with a median of 23.8 months versus 13.0 months, respectively (HR=0.55; 95% CI: 0.44–0.69; p<0.001).^5,10

Image

In an exploratory analysis, 1L KISQALI + ET was observed to increase mOS by 11 months vs placebo + ET in pre/perimenopausal patients⁵

• Exploratory analysis for the NSAI subgroup with an extended median follow-up of 54 months⁵

• ET is defined as AI + LHRH

KISQALI is not recommended to be used in combination with tamoxifen.¹

Click the links below to find out more about OS results in patients treated with KISQALI + ET:

Summary of the safety profile

The most common adverse reactions (ARs) (reported at a frequency ≥20%) in the pooled dataset for which the frequency for KISQALI plus any combination exceeds the frequency for placebo plus any combination were neutropenia, infections, nausea, fatigue, diarrhoea, leukopenia, vomiting, headache, constipation, alopecia, cough, rash, back pain, anaemia and abnormal liver function tests.¹
 

Study designs

MONALEESA-2: Phase III trial of KISQALI + AI (n=334) vs placebo + AI (n=334) in postmenopausal patients with HR+/HER2– aBC. The primary endpoint was locally assessed PFS. OS was a key secondary endopoint. In the primary and updated analyses, mPFS was significantly longer with KISQALI + AI than with placebo + AI (updated analysis: 25.3 months vs 16.0 months; HR for disease progression or death=0.57; 95% CI: 0.46–0.70, p<0.001)^3,8

MONALEESA-3: Phase III trial of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2– aBC who were treatment naive or had received up to 1 line of prior ET in the advanced setting. The primary endpoint was locally assessed PFS. KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with an mPFS of 20.5 versus 12.8 months (HR=0.59; 95% CI: 0.48–0.73, p<0.001). OS was a secondary endpoint.⁹

MONALEESA-7: Phase III trial of KISQALI + ET (NSAI or tamoxifen) (n=335) vs placebo + ET (NSAI or tamoxifen) (n=337) in pre- and perimenopausal patients with HR+/HER2– aBC. The primary endpoint was investigator-assessed PFS. KISQALI was associated with a significant improvement in PFS, with a median of 23.8 vs 13.0 months with placebo (HR=0.55; 95% CI: 0.44–0.69, p<0.001). The key secondary endpoint was OS.^5,10

*Quantitative and qualitative primary research with more than 500 respondents (including 392 physicians managing metastatic breast cancer patients and patients themselves). Top reported goals included OS and maintaining day to day activities.²

1L, first-line; 2L, second-line; aBC, advanced breast cancer; CDK4/6, cyclin-dependent kinase 4 and 6; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival.

References

1. KISQALI (ribociclib) Summary of Product Characteristics.

2. Pfizer Oncology. Meaningful Goals in the Management of mBC. 2017. Available at: https://www.breastcancervision.com/sites/default/files/section-pdf/mbc_goals-whitepaper_final_with_date.pdf [Accessed February 2025].

3. Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950.

4. Neven P, et al. Breast Cancer Res 2023;25:103.

5. Lu Y-S, et al. Clin Cancer Res  2022;28:851–859.

6. Slamon DJ, et al. N Engl J Med 2020;382:514–524.

7. Im S-A, et al. N Engl J Med 2019;381(4):307–316.

8. Hortobagyi GN, et al. Ann Oncol 2018;29:1541–1547.

9. Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.

10. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.

UK | February 2025 | 442176