- Novartis AG NVS shares are trading higher in the premarket session after its breast cancer drug showed clinical benefit in early-stage breast cancer.
- Novartis announced topline results from an interim analysis of the NATALEE Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer at risk of recurrence.
- The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met.
- Kisqali plus ET significantly reduced the risk of disease recurrence, compared to standard adjuvant endocrine therapy 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.
- Rival drug Verzenio by Eli Lilly And Co LLY has approval in the early setting for women at high risk of recurrence after surgery.
- "Everything else being equal on the efficacy side, it is anticipated that Kisqali could beat Verzenio by offering a more convenient side effect profile," Reuters notes, citing Stifel analyst Eric Le Berrigaud.
- He added that the trial update would boost low market confidence in targets issued by CEO Vas Narasimhan for annual sales growth of 4% through 2027 and a core operating income margin of 40% from 2027.
- In 2022, Kisqali generated $1.23 billion in sales, up 31% Y/Y.
- Price Action: NVS shares are up 6.59% at $89.10 during the premarket session on the last check Monday.
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