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Susanne Schaffert, CEO of Novartis Oncology.
Novartis has announced thatThe New England Journal of Medicine(NEJM) has published data showing that the study inphase III Monalessa 2kisqali (ribociclib) plus letrozole has shown a statistically significant improvement in overall survival of themetastatic breast cancer. The data show an increase of more than 12 months in overall survival with shortin combination with letrozole, compared with letrozole alone, in postmenopausal women with advanced or metastatic hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)1 breast cancer. The overall survival data from the Monaleesa 2 study were presented at the Congress of theEuropean Society for Medical Oncology(ESMO) in September 2021.
In addition, the publication in NEJM includes additional analyzes that corroborate the benefit of median overall survival longest “ever reported” in patients with HR+/HER2- advanced breast cancer, supporting the use of combination therapy with kisqali as first-line treatment.” These positive overall survival data for Monaleesa-2 mark a huge progress in extension of the lives of patients living with advanced breast cancer. Achieving this overall survival is the gold standard for clinical trials and is particularly impressive in the front line scenesaid Gabriel N. Hortobagyi, professor of medicine and fellow of the American College of Physicians (FACP) at the University of Texas MD Anderson Cancer Center.
Despite superior subsequent use of CDK4/6 inhibitor therapy in the placebo group, the ribociclib treatment demonstrated a statistically significant overall survival benefit of more than a year. These data consolidate ribociclib and letrozole as the preferred combination of CDK4/6 inhibitors to offer more life to postmenopausal women with advanced HR+/HER2- disease.
The NEJM publication explains that the median overall survival among patients in the kisqali plus letrozole group it was more than five years (63.9 months), compared to four years (51.4 months) in the placebo group (HR=0.76, 95 percent CI: 0.63-0.93, two-sided p=0.008). In fact, experts point out that patients who received first-line treatment saw a 24 percent reduction inDeath riskwith kisqali plus letrozole compared with letrozole monotherapy.
In this same line, the overall survival benefit with kisqali more letrozole followed increasing over time, with a survival rate for patients receiving kisqali plus letrozole of 52.3 percent at five years (8.4 percent more than letrozole alone) and 44.2 percent at six years (12, 2 percent more than letrozole monotherapy). Fewer patients in the kisqali plus letrozole group received further treatment on any line of CDK4/6 inhibitor therapy (34.4 percent for letrozole monotherapy compared with 21.7 percent); significant overall survival benefit with kisqali plus letrozole was consistent after adjusting for subsequent therapy on any line of CDK4/61 inhibitor therapy.
Schaffert: “The overall survival benefit of kisqali plus letrozole was improving over time for patients”
On the other hand, patients who received kisqali plus letrozole compared to those who received letrozole alone experienced a additional one-year delay in chemotherapy subsequent (50.6 months compared to 38.9 months in the placebo group)
“What is most compelling about these data from the Monaleesa 2 study is that the overall survival benefit of kisqali plus letrozole improved over time for patients, regardless of disease characteristics. These significant results are raising the standard of care for people with advanced breast cancer, who now have a increased life expectancysaid Susanne Schaffert, PhD, President of Novartis Oncology. “The data continues to show that kisqali differs from other CDK4/6 inhibitors, and we look forward to further studying its full potential benefits for patients living with HR+/HER2- breast cancer,” she added.
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