Novartis Breast Cancer Drug Trial a Success

Novartis AG (NVS) has achieved a big breakthrough in its bid to treat cases of advanced breast cancer.

In a statement, the Swiss pharmaceutical company, which has been working on breast cancer cures for more than 30 years, announced that its double-blind, placebo-controlled trial with 572 randomized patients delivered "an improvement in progression-free survival," which was the primary endpoint for patients with HR+/HER2- advanced breast cancer with PIK3CA mutation. Novartis used BYL719, an investigational, orally bioavailable PI3K inhibitor, in combination with fulvestrant, a medication used to treat hormone receptor-positive metastatic breast cancer.

"BYL719 is the only alpha-specific PI3K inhibitor and the first one to show potential increased benefit and acceptable tolerability for patients," said Samit Hirawat, managing director and head of Novartis’s Oncology Global Drug Development. "We are encouraged by the results observed in the SOLAR-1 study and look forward to submitting the data to an upcoming medical congress and starting discussions with health authorities worldwide."

The company noted that there are currently no approved PI3K inhibitors for HR+ advanced breast cancer, even though approximately 40% of sufferers experience PIK3CA gene mutations. Novartis, citing several studies, added that PI3K plays an important role in regulating cell processes and is the most frequently altered step to promoting tumor growth, disease progression and treatment resistance.

News of Novartis’s breakthrough came shortly after FiercePharma reported that the Basel, Switzerland-based company appointed yet another interim CEO to run its troubled Korea business. Joshi Venugopal, the former chief of Novartis’s Asia Pacific arm, faces a big task as the company’s operations in the country have been rocked by allegations of a kickback scheme to doctors aimed at driving prescriptions. (See also: Novartis to Spin Off Eye-Care Unit, Buy Back $5B in Shares.)

The Korean Ministry of Health and Welfare and other bodies have already fined Novartis for its misconduct. A criminal trial is now taking place in Seoul to establish whether the company used academic events sponsored by medical journals to funnel about $2.3 million in illegal payments to doctors.

Novartis’s shares have risen 13% over the past two months after the company delivered solid second-quarter earnings results. (See also: GSK Shares Surge on $13B Buyout Deal Struck With Novartis.)

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