MedicalResearch.com Interview with: Wolfgang Janni, MD, PhD University of Ulm MONALEESA-2 investigator MedicalResearch.com: What is the background for the MONALEESA-2 trial? What are the main findings? Response: The Phase III MONALEESA-2 trial was the primary study that supported the recent European approval of Kisqali (ribociclib). Findings from the study showed superior efficacy and demonstrated safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who received no prior therapy for their advanced breast cancer. The trial showed Kisqali plus letrozole reduced the risk of progression or death by 43% versus letrozole alone. At a pre-planned analysis, Kisqali plus letrozole demonstrated a median progression-free survival (PFS) of 25.3 months compared to 16.0 months for letrozole alone (HR=0.568 (95% CI: 0.457-0.704; p<0.0001)). More than half of patients (55%) with measurable disease taking Kisqali plus letrozole experienced a tumor reduction of at least 30%. Finally, Kisqali plus letrozole demonstrated rapid clinical improvement in patients with measurable disease, with 76% seeing a reduction in tumor size after only eight weeks versus 67% with letrozole alone. Most side effects in the MONALEESA-2 trial were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and/or reduction. The most common grade 3/4 adverse events (reported at a frequency ≥5%) for Kisqali plus letrozole compared to letrozole alone were neutropenia (60% vs 1%, respectively), leukopenia (21% vs 1%), hypertension (10% vs. 11%), increased alanine aminotransferase level (9% vs. 1%), lymphopenia (7% vs. 1%) and increased aspartate aminotransferase level (6% vs. 1%). (more…)