Novartis Drug Cut Death Risk by 35 Percent in Gene Mutation Breast Cancer

Excerpt:

“An experimental cancer drug that Novartis hopes will raise the profile of its oncology portfolio cut the risk of death or disease progression by more than a third in breast cancer patients with a hard-to-target gene mutation.

“The Swiss drugmaker’s BYL719, a so-called PI3K inhibitor also known as alpelisib, combined with hormone therapy fulvestrant boosted median progression-free survival (PFS) to 11 months, up from 5.7 months for patients who got only hormone therapy, the company said on Saturday.”

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Alpelisib Improves PFS for Advanced PIK3CA-Mutated Breast Cancer

Excerpt:

“A trial assessing the alpha-specific PI3K inhibitor alpelisib with fulvestrant met its primary endpoint of PFS among patients with hormone receptor-positive, HER-2-negative advanced breast cancer with a PIK3CA mutation, according to the agent’s manufacturer.

“Alpelisib (BYL719, Novartis) is an inhibitor of the PI3K pathway. About 40% of patients with hormone receptor-positive breast cancer harbor PIK3CA mutations.

“The phase 3 global, double-blind SOLAR-1 study included 572 women and men with PIK3CA-mutated hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer that progressed on or following prior aromatase inhibitor treatment with or without a CDK4/6 inhibitor.”

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Alpelisib Active in PIK3CA-Altered Solid Tumors

Excerpt:

“Alpelisib (BYL719) induced a disease control rate (DCR) of 58.2% in patients with advanced solid tumors, according to results from a phase Ia study published in the Journal of Clinical Oncology.

“Treatment with the oral PIK3CA selective inhibitor led to a stable disease rate of 52.2%. Thirteen (9.7%) patients maintained stable disease for more than 24 weeks.

“Investigators reported ‘encouraging signs of antitumor activity’ in patients with PIK3CA-mutant, ER-positive/HER2-negative breast cancer, and other PIK3CA-altered advanced solid tumors.”

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