Novartis Breast Cancer Drug Cuts Risk Of Death By 35 Percent In Patients With PIK3CA Gene Mutation

A doctor looks at the result of woman's mammogram.
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An experimental breast cancer drug by Switzerland-based drugmaker Novartis cuts the risk of death or disease progression by more than 30 percent in breast cancer patients with a gene mutation associated with poor prognosis.

In a statement released on Saturday, October 20, Novartis said that the drug called BYL719, a PI3K inhibitor also known as alpelisib, in combination with the hormone therapy fulvestrant, improved progression-free survival (PFS) of patients to 11 months, or 5.7 months longer compared with patients who only received hormone therapy.

The company said that BYL719 plus fulvestrant reduced risk of death or progression in this group of patients by about 35 percent.

The findings were based on the results of the SOLAR-1 clinical study that involved patients with HR+/HER2- advanced breast cancer, who are carriers of PIK3CA gene mutations.

The results were released on October 20 at the European Society for Medical Oncology’s annual conference in Munich, Reuters reported.

“BYL719 has been shown to potentially inhibit the PI3K pathway and have antiproliferative effects. In addition, cancer cell lines with PIK3CA mutations were more sensitive to BYL719 than those without the mutation across a broad range of different cancers,” Novartis said in a statement.

A doctor assists a patient undergoing mammogram.
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PIK3CA mutations are the most common genetic change in hormone-receptor positive breast cancer, but clinical trials of agents designed to address this pathway to tumor growth has been largely disappointing.

Other pharmaceutical companies, including Roche, have encountered issues with their experimental drugs, which makes Novartis’ progress welcome news.

Fabrice Andre, from France’s Institut Gustave Roussy, said that the results of the SOLAR-1 study are to date the most encouraging from a trial that evaluated a PI3K inhibitor.

He added that the findings can potentially allow physicians to address an unmet need in this particular group of patients by using a biomarker-driven treatment. Like other drug companies, Novartis seeks to personalize treatment for cancer patients by using biomarkers such as those that show PIK3CA gene mutations to help guide treatment.

Novartis’s cancer drug development head Samit Hirawat said that the pharmaceutical giant plans to file for the approval of the alpelisib drug with health regulators this year.

Breast cancer remains one of the most common forms of cancer affecting women. The disease is expected to claim nearly 41,000 lives in 2018, but according to figures from the nonprofit organization Breastcancer.org, death rates from breast cancer have been dropping since 1989.

The decline is believed to be the result of treatment advances, earlier detection through screening, and raised awareness.