Novartis AG NVS announces positive top-line results from an interim analysis of late-stage NATALEE study on breast cancer drug Kisqali.
NATALEE is a global phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Kisqali with endocrine therapy (ET) as adjuvant treatment versus ET alone in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2)- early breast cancer (EBC). The study is being conducted in collaboration with Translational Research In Oncology (TRIO).
The Independent Data Monitoring Committee recommended that the study be stopped early as the primary endpoint of invasive disease-free survival (iDFS) was met. Kisqali and ET together significantly reduced the risk of disease recurrence compared to standard adjuvant ET alone with consistent benefit in patients with stage II and stage III EBC, regardless of nodal involvement.
Per the NATALEE study protocol, patient follow-up will continue to evaluate long-term outcomes, including overall survival.
The positive top-line results from NATALEE support Novartis’ efforts to expand the benefits of Kisqali to patients with earlier stages of breast cancer.
Please note that Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor (AI) as initial ET or fulvestrant as initial ET or following disease progression on ET in postmenopausal women or men. Kisqali is approved in the EU for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination with either an AI or fulvestrant as initial ET or following disease progression.
Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for breast cancer, released in January 2023, recommend Kisqali as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.
Novartis plans to build on the findings from NATALEE with ADJUVANT WIDER, an open-label phase IIIb trial evaluating Kisqali plus ET in a population of HR+/HER2- patients with stage II and III EBC that is closer to a real-world population.
Novartis has collaborated with SOLTI, which is leading the HARMONIA study to evaluate whether Kisqali changes tumor biology to enable a better response to ET compared to Ibrance (palbociclib) for patients with metastatic HR+/HER2-, HER2-enriched subtype.
Sales in 2022 came in at $1.2 billion, up 31% from a year ago.
Shares of Novartis gained 3.1% in the past year compared with the industry’s growth of 2.5%.
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Novartis’ performance in the fourth quarter was mixed, as earnings beat estimates, but revenues lagged due to generic competition for Gilenya and a decline in Cosentyx sales. With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company. Drugs like Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio should continue to fuel growth and offset the impact of generic competition. Pluvicto and Scemblix saw impactful launches and the Leqvio launch continues to progress.
Novartis expects net sales for 2023 to grow in the low- to mid-single digits.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the overall healthcare sector are Novo Nordisk NVO and Ligand Therapeutics LGND, both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43. Estimates for 2024 have increased by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters.
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