Novartis breast cancer drug Kisqali plus endocrine therapy extends PFS

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Novartis breast cancer drug Kisqali (ribociclib) plus endocrine therapy has succeeded in extending progression-free survival (PFS) compared to only endocrine therapy in three phase 3 MONALEESA trials.

The findings come from the Swiss pharma company’s release of data from subgroup analyses of the three pivotal trials in pre-, peri- and postmenopausal women, irrespective of the presence of visceral metastases and having hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

Denise Yardley of Sarah Cannon Research Institute, who was the Principal Investigator of the trials, said: “Nearly 60% of patients enrolled in the MONALEESA clinical trials had visceral metastases, and all benefited from treatment with ribociclib in combination with endocrine therapy.

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“These results, coupled with the NCCN and ABC4 recommended treatment guidelines for HR+ advanced breast cancer patients with visceral metastases, support the use of ribociclib combination therapy as a standard of care in this patient population.”

Novartis breast cancer drug Kisqali plus endocrine therapy extends PFS

Novartis breast cancer drug Kisqali plus endocrine therapy extends PFS. Photo courtesy of Novartis AG.

Kisqali plus endocrine therapy was shown to have extended median PFS by 11.5 months in MONALEESA-2 and 13.4 months in MONALEESA-7 in patients with visceral metastases when compared to endocrine therapy alone.

In the MONALEESA-3 trial, median PFS for patients with visceral metastases could not be reached yet compared to 16.5 months median PFS in patients subjected to endocrine therapy alone.

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Kisqali plus endocrine therapy showed consistent efficacy in the MONALEESA trials in patients with and without visceral metastases.

The overall response rate (ORR) in patients with visceral metastases and measurable disease who were subjected to Kisqali plus endocrine therapy compared to only endocrine therapy was 53% vs 40% in MONALEESA-2, 50% vs 38% in MONALEESA-7 and 48% vs 31% in MONALEESA-3.

The ORR in patients without visceral disease was shown as 59% vs 35%, 52% vs 32% and 49% vs 39% in MONALEEA-2, MONALEESA-7 and MONALEESA-3 trials, respectively.

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Samit Hirawat – Head of Novartis Oncology Global Drug Development, said: “Patients living with HR+/HER2- advanced breast cancer who have visceral metastases often have a poorer prognosis and are at higher risk for treatment resistance and disease progression than those without.

“These sub analyses reaffirm that it is critical to treat HR+ advanced breast cancer with a CDK4/6 combination therapy, such as Kisqali plus fulvestrant or an aromatase inhibitor, to give all patients, especially those with visceral metastases, the strongest option for delaying disease progression.”

According to Novartis, adverse events for patients with visceral metastases were in line with those noted in the overall study populations and manageable generally by either dose interruptions or reductions.

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