What are you looking for?
All Filters
Therapeutic Area
Therapeutic Area
Date Published
Date published
Group 2365.png

Efficacy - Further analysis

 

MONALEESA trials Subgroup Analysis, PFS2 Data , and Delayed time to chemotherapy results

Subgroup analysis in Monaleesa-2 Trial

KISQALI achieved a consistent OS benefit in patients with bone-only metastases1

 

Bone-Only Metastases

 

Frame 427318830.png

WITH

Layer_17.png

WITHOUT

Layer_18.png

Adapted from ref 1

  • OS benefit for patients with and without bone-only metastases was consistent with that of the ITT population1

KISQALI exhibited an OS benefit in patients with liver metastases, despite a worse prognosis1

 

Liver Metastases

 

Frame 427318833.png

WITH

Layer_19.png

WITHOUT

Layer_20.png

Adapted from ref 1

  • OS benefit for patients with and without liver metastases was consistent with that of the ITT population1

KISQALI achieved an OS benefit in patients with liver or lung metastases, despite a poor prognosis1

 

Lung Metastases

 

Frame 427318836.png

WITH

30

WITHOUT

31

Adapted from ref 1

  • OS benefit for patients with and without liver or lung metastases was consistent with that of the ITT population1

KISQALI demonstrated a consistent OS benefit even in patients with greater disease burden1

 

Metastatic Sites

 

Frame

 

Results also favored treatment with ribociclib regardless of the number of metastatic sites. 
Compared with letrozole alone, ribociclib plus letrozole improved OS for patients with <3 metastatic sites 
(HR, 0.78; 95% CI, 0.61–1.00) and for patients with 3 metastatic sites (HR, 0.71; 95% CI, 0.51–0.98). 
The survival benefit with ribociclib was similarly consistent regardless of prior adjuvant or neoadjuvant 
chemotherapy or endocrine therapy.

Frame 427318841.png

 

metastatic sites

(HR, 0.78; 95% CI, 0.61–1.00)

Frame 427318842.png

 

metastatic sites

(HR, 0.71; 95% CI, 0.51–0.98)
  • OS benefit for patients with <3 and was ≥3 metastatic sites was consistent with that of the ITT population1

Adapted from ref 1

Study Design:

(MONALEESA-2) trial, which evaluated the efficacy and safety of the combination of ribociclib and letrozole as initial therapy in patients with HR-positive, HER2-negative advanced breast cancer.2
In this randomized, double-blind, placebo-controlled, phase 3 trial conducted in 29 countries, patients at 223 trial centers were randomly assigned to receive either oral ribociclib (600 mg per day on a 3-weeks-on, 1-week-off schedule in 28-day treatment cycles) plus letrozole (2.5 mg per day on a continuous schedule) or placebo plus letrozole.2 With median follow up of 80 months.3

Benefits beyond the 1st line period

MONALEESA-7: Efficacy4
KISQALI extended PFS2a

 

PFS2 data confirms benefit of KISQALI beyond the first-line period in this patient Population4

32

a PFS2 is defined as time from randomization to disease progression during receipt of second-line therapy or death.4
Goserelin included in all combinations1. Ribociclib is not recommended for concomitant use with tamoxifen.5

 

Median time to chemotherapy delayed 4 years or more Across all 3 phase III trials

Monaleesa-2:

50.6 Months (KISQALI+AI )
1-year increase

Monaleesa-3:

48.1 months  KISQALI + Fulvestrant vs 28.8 Months placebo + AI

Monaleesa-7:

50.9 Months with Kisqali+ET+goserelin vs 36.8 Months with placebo + ET + goserelin.

MONALEESA-2: KISQALI + AI IN POSTMENOPAUSAL PATIENTS3

 

At a median follow-up of 80 months3

1

 

TIME TO CHEMOTHERAPY | KISQALI + AI3 

Group 2353.png
2

 

MONALEESA-7: KISQALI + ET IN PREMENOPAUSAL PATIENTS4

 

At a median follow-up of 53.5 months
50.9 MONTHS mTTC with KISQALI + ET + goserelin 
vs 36.8 months with placebo + ET + goserelin; HR=0.69 
(95% CI: 0.56-0.87)

3

 

MONALEESA-3: KISQALI + FULVESTRANT IN POSTMENOPAUSAL PATIENTS7

 

At a median follow-up of 56.3 months
48.1 MONTHS mTTC with KISQALI + Fulvestrant
vs 28.8 months with placebo + Fulvestrant HR=0.70 (95% CI: 0.57-0.88)

  • Time to chemotherapy was an exploratory end point and was defined as the time from randomization to the beginning of the first chemotherapy after discontinuing study treatment7

 

HR, hazard ratio; ITT, intention to treat; LET, letrozole; mOS, median overall survival; OS, overall survival; PBO, placebo; RIB, ribociclib; CI, confidence interval; NSAI, nonsteroidal aromatase inhibitor; NR, not reached; PFS, progression-free survival; PFS2, progression-free survival 2; ET, Endocrine Treatment; mTTC, median time to chemotherapy,AI: Aromatase Inhibitor.

References

  1. Jacobson A. Ribociclib Improves Overall Survival in HR+/HER2–Metastatic Breast Cancer Across Common Genomic and Clinical Subtypes. The Oncologist. 2022 Mar;27(Supplement_1):S11-2.

  2. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. New England journal of medicine. 2016 Nov 3;375(18):1738-48.

  3. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P. Overall survival with ribociclib plus letrozole in advanced breast cancer. New England Journal of Medicine.2022 Mar 10;386(10):942-50.

  4. Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre-and Perimenopausal Patients with HR+/HER2− Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical TrialUpdated Overall Survival Analysis of the MONALEESA-7 Trial. Clinical Cancer Research. 2022 Mar 1:OF1-9

  5. KISQALI. Summary of Products Characteristics (SMPC). available at: https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf  . last accessed 16/6/2025

  6. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W,Conte P. Overall survival with ribociclib plus letrozole in advanced breast cancer. New England Journal of Medicine.Supplementary Appendix. 2022 Mar 10;386(10):942-50.

  7. Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Bianchi GV, Martín M, Nusch A, Sonke GS. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Annals of Oncology. 2021 Aug 1;32(8):1015-24.

Approved by Egyptian Drug Authority: HF0082OA4733/082025. Invalidation date: 28/08/2027.
Kindly report any violated online promotional, educational and awareness material not having this message to The General administration for Regulation of Marketing & Advertising Materials at: www.edaegypt.gov.eg

Kisqali QR.png

HF0424OA4807/102025 14/10/2027

 

        

Adverse Events Reporting

We encourage using the following Electronic reporting tool for reporting into the safety database directly:
If the electronic reporting tool is not working - please use the following: https://www.report.novartis.com
1 - Generic Mailbox: [email protected]
2 - CISCO: +20 2 2 2861000: Press 3 for Adverse Events Reporting