MedicalResearch.com Interview with:
Wolfgang Janni, MD, PhD
University of Ulm
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%).
MedicalResearch.com: What types of breast cancer patients may benefit from the combination of Kisqali plus letrozole?
Will Kisqali plus letrozole be available to US patients?
Response: The European Commission approved Kisqali in combination with an aromatase inhibitor to be used as first-line therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer.
Metastatic or advanced breast cancer means the cancerous cells have spread to other parts of the body, such as the brain, liver or bones. This is sometimes referred to as stage 3 (locally advanced) or stage 4 (metastatic) breast cancer. The most common type of advanced breast cancer is called hormone receptor-positive. It is characterized by tumors that express receptors for hormones such as estrogen or progresterone that can accelerate cancer cell growth. With the recent approval, Kisqali in combination with an aromatase inhibitor can be used to treat patients with HR+/HER2- locally advanced or metastatic breast cancer.
The US FDA approved Kisqali in combination with any aromatase inhibitor in March 2017.
MedicalResearch.com: What should readers take away from your report?
Response: Most importantly, women in Europe with HR+/HER2- advanced or metastatic breast cancer may have a new treatment that demonstrated strong progression-free survival of more than two years in the MONALEESA-2 trial. The approval of Kisqali in combination with any aromatase inhibitor allows oncologists to prescribe letrozole, anastrozole or exemestane, giving them the discretion to select the therapy they believe is most appropriate for each individual patient.
The MONALEESA-2 trial results also help us better understand the important role combination therapy plays in advanced breast cancer treatment. Worldwide, an estimated 250,000 women are diagnosed with advanced breast cancer each year and currently there is no cure. I’m encouraged by this treatment advancement as it provides oncologists in Europe with a powerful treatment option at diagnosis of advanced disease.
MedicalResearch.com: Is there anything else you would like to add?
Response: There is additional research in progress to further understand the role of Kisqali in the treatment of breast cancer. The MONALEESA-3 trial is evaluating first- and second-line ribociclib in combination with fulvestrant versus fulvestrant alone in men and post-menopausal women with HR+/HER2- advanced breast cancer. MONALEESA-7 is evaluating first-line ribociclib in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in pre-menopausal women with HR+/HER2- advanced breast cancer. Both of these trials are fully enrolled.
Additional trials for ribociclib include:
- The CompLEEment-1 and Ribecca-Studies, which are evaluating ribociclib plus letrozole as a first-line therapy in men and pre- or postmenopausal women with HR+/HER2- advanced breast cancer
- EarLEE-1, a trial currently enrolling which will evaluate ribociclib with endocrine therapy as adjuvant treatment in men and pre- and postmenopausal women with HR+/HER2- early breast cancer who have not previously been treated with CDK4/6 or aromatase inhibitors
Results from these studies will be presented at upcoming medical congresses.
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Citation: ESMO 2017
Kisqali® (ribociclib) has received EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor.
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