KISQALI + Fulvestrant in postmenopausal patients
1L in postmenopausal patients: KISQALI + fulvestrant significantly increased mOS benefit vs fulvestrant alone. (1)
1-year increase in mOS with KISQALI + fulvestrant vs fulvestrant alone. *(1)
MONALEESA-3: mOS at median 71-month follow-up
* HR 0.673; 95% CI: 0.504–0.899. (1)
MONALEESA-3 study design
MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, and safety and tolerability.
1L defined as: newly diagnosed (de novo) ABC patients or patients with relapse >12 months from completion of (neo)adjuvant ET with no treatment for ABC or metastatic disease.
2L was defined as: relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced or metastatic disease (early relapse); relapse >12 months from completion of (neo)adjuvant therapy with subsequent progression after one line of endocrine therapy for advanced or metastatic disease, and advanced or metastatic breast cancer at diagnosis that progressed after one line of endocrine therapy for advanced disease with no prior (neo)adjuvant treatment for early disease. (2)