Breast cancer targeted treatment! Novarce Kisqali performs in patients with incurable visceral metastasis HR-/HER2-advanced breast cancer:

Swiss pharmaceutical giant Novartis has released subgroup analysis data from three key Phase III MONALEESA studies of the new breast cancer-targeted drug Kisqali. The data showed that in patients with advanced breast cancer 2 negative (HR-/HER2-) pre-menopathic, peri-menopathic, post-menotinal hormone-positive, human skin growth factor(HR-/HER2-) advanced breast cancer, Kisqali combined endocrine therapy significantly extended progression-free survival (PFS) compared to endocrine alone treatment, regardless of whether the patient had visceral metastasis.
Denise Yardley, lead researcher at the Sarah Cannon Institute (SCRI), commented,
Nearly 60 percent of patients in the MONALEESA clinical study in the group had internal metastasis, and all patients benefited from Kisqali's combined treatment with endocrine. These results, coupled with the treatment guidelines recommended by NCCN and ABC4 for patients with advanced breast cancer with visceral metastasis, support Kisqali combination therapy as the standard of care for this patient group. Specifically,
patients with internal metastasis, Kisqali combined endocrine therapy extended the medium PFS by 11.5 months (24.9 months vs. 13.4 months) in the MONALEESA-2 study and by 13.4 months (23.8 months vs. 10.4 months) in the MONALEESA-7 study. In the MONALEESA-3 study, the middle PFS of Kisqali combined endocrine therapy was not yet reached in patients with internal organ metastasis, while the middle PFS in the endocrine alone treatment group was 16.5 months.
across MONALEESA clinical studies, Kisqali combined endocrine therapy showed consistent results in patients with visceral metastasis and in patients without visceral metastasis. In patients with internal metastasis and evaluatable diseases, the total remission rate (ORR) of Kisqali combined endocrine therapy was higher than that of endocrine alone, as follows: 53% vs. 40% (MONALEESA-2 study), 50% vs. 38% (MONALEESA-7), 48% vs. 31% (MONALEESA-3). In patients without visceral metastasis, The ORR of Kisqali combined endocrine therapy was also higher than that of endocrine alone, specifically: 59% vs 35% (MONALEESA-2 study), 52% vs 32% (MONALEESA-7), 49% vs 39% (MONALEESA-3).
safety data analyzed in this subgroup show that adverse events in visceral metastasis patients are consistent with adverse events observed in the overall study group and can usually be managed through dose interruption or reduction.
"Patients with HR-/HER2-advanced breast cancer with visceral metastasis generally have poor prognosis and a higher risk of treatment resistance and disease progression than those without visceral metastasis," said Samit Hirawat, global head of drug development at Novartic Oncology. The subgroup analysis data from three key Phase III studies reaffirmed that CDK4/6 inhibitor combination therapies (such as Kisqali combined fluorovirs or an aromatase inhibitor) were the strongest options for prolonging disease progression in all patients, especially those with visceral metastasis.
Kisqali is an oral targeted CDK4/6 inhibitor that selectively inhibits cell cycle protein-dependent kinase 4/6 (CDK4/6), restores cell cycle control, and blocks tumor cell proliferation. Out-of-control cell cycle is a signature feature of cancer, and CDK4/6 is overactive in many cancers, causing cell proliferation to spiral out of control. CDK4/6 is a key regulatory factor for cell cycles, which can trigger a shift in cell cycles from growth (G1) to DNA replication (S1). In estrogen-positive (ER-plus) breast cancer, THE EXCESS4/6 is highly active, and CDK4/6 is a key downstream target for ER signals. Preclinical data show that cdK4/6 and ER signal double inhibition have synergies and can inhibit the growth of G1 stage ER-breast cancer cells.
regulatory aspects, the FDA and the European Union EC initially approved Kisqali in March and August 2017 as an initial endocrine therapy for first-line treatment in post-menopathic women with HR-/HER2-local late stage or metastatic breast cancer. This approval is based on data from MONALEESA-2, a key clinical study.
July, Kisqali was approved by the FDA for the treatment of hormone-positive, human skin growth factor-positive, 2-negative (HR-/HER2-) advanced or metastassic breast cancer patients. In the U.S. market, Kisqali is currently the only CDK4/6 inhibitor for the treatment of pre-menocental, peri-menophageal, post-menophageal female patients with a combination aromatic enzyme inhibitor, and also for first- or second-line treatment for post-menophageal female patients.
November, the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) issued an active review recommending approval for the expansion of Kisqali's allergies. Specifically, CHMP recommends approval of Kisqali combined fluorovirts (fulvestrant) as an initial endocrine therapy for hormone-positive, human skin growth factor recipient 2 negative (HR-/HER2-) localized late stage or metastatic breast cancer patients, and for patients who have previously received endocrine therapy. In addition, CHMP recommends approval of Kisqali combined endocrine therapy and a progesterone-releasing hormone agonist (LHRH) for pre-menopathic, peri-menoanthe female patients. (Bio Valley)