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Novartis Breast Cancer Drug Meets Primary Goal in Phase III
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Novartis AG (NVS - Free Report) announced that the phase III trial, SOLAR-1, evaluating pipeline candidate BYL719, has met the primary endpoint.
The trial evaluated BYL719, an experimental alpha-specific PI3K inhibitor, in combination with AstraZeneca’s (AZN - Free Report) Faslodex compared to Faslodex alone, in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor.
The trial randomized 572 patients in a 1:1 ratio to receive continuous oral treatment with BYL719 300mg or placebo once daily in combination with Faslodex intramuscular injections on days 1 and 15 on the first cycle and day 1 of each subsequent 28-day cycle as per Faslodex prescribing information.
The trial met the primary endpoint as patients treated with BYL719 showed an improvement in progression-free survival (PFS).
Approximately 40% of HR+ advanced breast cancer patients have PIK3CA mutations. The PI3K pathway is the most commonly mutated pathway associated with tumor progression in HR+ advanced breast cancer.
The trial will continue to assess data for secondary endpoints. Novartis expects to submit full results to an upcoming medical congress. The company expects to initiate discussions with regulatory authorities worldwide.
The initial positive results from the trial increases the likelihood of trial success and a subsequent approval of the candidate.
Novartis’ stock has declined 3.5% in the year so far against the industry's 7.9% growth.
Novartis already has Kisqali in its portfolio for breast cancer. Kisqali is approved in the United States for the treatment of women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
However, competition is stiff in the breast cancer market with the likes of Roche (RHHBY - Free Report) .
Approval of new drugs and label expansion of key drugs bode well for Novartis.
The company restructured its business and plans to focus on becoming a core drug-focused company, powered by data and digital technologies. It is looking to spin-off its ophthalmology division, Alcon. Earlier, Novartis also divested its stake in the OTC joint venture with GlaxoSmithKline (GSK - Free Report) for $13 billion.
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Novartis Breast Cancer Drug Meets Primary Goal in Phase III
Novartis AG (NVS - Free Report) announced that the phase III trial, SOLAR-1, evaluating pipeline candidate BYL719, has met the primary endpoint.
The trial evaluated BYL719, an experimental alpha-specific PI3K inhibitor, in combination with AstraZeneca’s (AZN - Free Report) Faslodex compared to Faslodex alone, in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor.
The trial randomized 572 patients in a 1:1 ratio to receive continuous oral treatment with BYL719 300mg or placebo once daily in combination with Faslodex intramuscular injections on days 1 and 15 on the first cycle and day 1 of each subsequent 28-day cycle as per Faslodex prescribing information.
The trial met the primary endpoint as patients treated with BYL719 showed an improvement in progression-free survival (PFS).
Approximately 40% of HR+ advanced breast cancer patients have PIK3CA mutations. The PI3K pathway is the most commonly mutated pathway associated with tumor progression in HR+ advanced breast cancer.
The trial will continue to assess data for secondary endpoints. Novartis expects to submit full results to an upcoming medical congress. The company expects to initiate discussions with regulatory authorities worldwide.
The initial positive results from the trial increases the likelihood of trial success and a subsequent approval of the candidate.
Novartis’ stock has declined 3.5% in the year so far against the industry's 7.9% growth.
Novartis already has Kisqali in its portfolio for breast cancer. Kisqali is approved in the United States for the treatment of women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
However, competition is stiff in the breast cancer market with the likes of Roche (RHHBY - Free Report) .
Approval of new drugs and label expansion of key drugs bode well for Novartis.
The company restructured its business and plans to focus on becoming a core drug-focused company, powered by data and digital technologies. It is looking to spin-off its ophthalmology division, Alcon. Earlier, Novartis also divested its stake in the OTC joint venture with GlaxoSmithKline (GSK - Free Report) for $13 billion.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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