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Novartis Presents Additional Data on Breast Cancer Candidate


Novartis AG NVS announced additional data from a phase III SOLAR-1 study, currently evaluating its pipeline candidate, BYL719 (alpelisib), in combination with AstraZeneca's AZN Faslodex (fulvestrant).

The test assessed the combo of BYL719, an investigational alpha-specific PI3K inhibitor, and AstraZeneca’s Faslodex compared with Faslodex alone in postmenopausal women and men suffering 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 (AI) treatment.

In the study, BYL719 plus Faslodex doubled the median progression-free survival (PFS) in patients with the above-mentioned disease. The proposed combined regime also consistently demonstrated a clinically meaningful treatment effect after progression on an AI or post receiving one additional therapy for addressing advanced breast cancer.

The updated results from the study were presented at the San Antonio Breast Cancer Symposium.

Patients who progressed within 12 months after receiving AI experienced a median PFS of 11.0 months after getting the combo therapy compared with the 6.8-month routine on fulvestrant only. Median PFS was also superior for patients administered with the combo therapy in comparison to those subject to an additional line of therapy.

Shares of Novartis have gained 6.1% year to date compared with the industry's increase of 9.1%.

In August 2018, Novartis announced that the study met the primary endpoint as patients treated with BYL719 showed a positive response in terms of PFS.

The study will continue to analyze data for secondary endpoints. The company expects to initiate discussions with regulatory authorities worldwide.

The favorable top-line results from the program increases the likelihood of success and a subsequent approval of the candidate.

Novartis already has Kisqali in its portfolio for treating breast cancer. The drug 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.

Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company BMY and Merck & Co., Inc. MRK. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates have been revised 6.6% upward for 2018 and 4.1% for 2019 over the past 60 days.

Merck’s earnings estimates have been inched 1.4% up for 2018 and 0.9% for 2019 over the past 60 days. The stock has surged 39.2% year to date.

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