Novartis’ Kisqali, a treatment for metastatic breast cancer, showed a consistent overall survival benefit in patients with visceral metastases who have a relatively worse prognosis, the company said.
Novartis said it planned to release the subgroup analysis on the results of the phase-3 MONALEESA-7 and MONALEESA-3 studies on Kisquali at the online meeting of the American Society of Clinical Oncology (ASCO) on Friday and Saturday this week.
According to the analysis, the combination of Kisqali with endocrine therapy increased overall survival with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer with visceral metastases. The result was consistent with the benefit shown in the overall study populations, the company said.
“The analysis, looking across two phase-3 trials, supports the use of Kisqali in the first-line setting regardless of menopausal status or metastatic location,” said Denise Yardley, principal investigator at Sarah Cannon Research Institute, in a press release. “Patients with visceral metastases generally face worse prognosis and a higher risk for treatment resistance, so the consistent overall survival results with Kisqali combination therapy for these patients is compelling.”
The MONALEESA trials evaluated Kisqali in premenopausal women in combination with nonsteroidal anti-inflammatory (NSAI) drug plus goserelin (MONALEESA-7), and in postmenopausal women in combination with fulvestrant (MONALEESA-3). About 60 percent of the participants had visceral metastases.
The combo of Kisquali and endocrine therapy reduced death risk by 30 percent in the MONALEESA-7 study. The combo of Kisqali and fulvestrant lowered death risk by 20 percent in MONALEESA-3.
In patients with liver metastases, Kisqali combo treatment showed a 47 percent reduction in the risk of death in MONALEESA-7 and a 37 percent reduction in MONALEESA-3. The adverse events were consistent with the overall patients, the company said.
“Superior overall survival with Kisqali is proven in two phase-3 trials, and this subgroup analysis shows that Kisqali could make a difference in survival even among patients with the most aggressive forms of advanced breast cancer,” said Susanne Schaffert, head of Novartis Oncology.
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