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Novartis Kisqali NATALEE Analysis Reinforces Consistent Reduction In Risk Of Recurrence Across Key Subgroups Of Patients With Early Breast Cancer
Novartis will present late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival (iDFS) from the pivotal phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2023. After 27.7 months of follow-up, the iDFS benefit with Kisqali (ribociclib) plus endocrine therapy (ET) was consistent across key prespecified subgroups, compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (see table below)1. Results were also consistent with those in the overall trial population, reinforcing that the benefit was not driven by a specific patient subgroup.
"Subgroup analyses provide a more comprehensive picture of clinical benefit for patients and are critical to guiding treatment decisions, as they help indicate how different breast cancer subgroups might respond to treatment," said Aditya Bardia, M.D., Attending Physician, Medical Oncology, Mass General Cancer Center and Associate Professor, Medicine, Harvard Medical School and NATALEE trial investigator. "Given the outcomes of patients treated with endocrine therapy alone, this analysis outlines the potential benefit of adding ribociclib to endocrine therapy to reduce the risk of recurrence. These data provide important insight into how we think about residual risk in this population and make adjuvant treatment decisions for patients with localized breast cancer."
"Despite endocrine therapy, cancer recurrence remains unpredictable, and too many patients diagnosed with stage II or III HR+/HER2- early breast cancer experience their cancer coming back. This analysis further reinforces the potential of ribociclib to address the need for a new adjuvant option that reduces the ongoing risk of recurrence consistently across many types of at-risk patients," said Jeff Legos, executive vice president, global head of oncology development at Novartis. "These results from the NATALEE trial add to the wealth of efficacy, safety and quality of life data suggesting that ribociclib, if approved, could provide healthcare providers with a new option to help keep their patients living well and cancer-free."
Further analysis of the NATALEE trial is ongoing. Additional data, including the final efficacy analysis of the NATALEE trial, will be shared at upcoming medical meetings.
NATALEE is a global phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with ET as adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO2. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable. The primary endpoint of NATALEE is iDFS as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial.
Results previously announced at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023 showed ribociclib plus ET, compared to ET alone, lowered the risk of cancer recurrence by 25.2% (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014), along with consistent clinically meaningful iDFS benefit across key pre-specified subgroups: AJCC Tumor Stage II (HR=0.761; 95% CI: 0.525, 1.103), AJCC Tumor Stage III (HR=0.740; 95% CI: 0.592, 0.925), node-negative disease (HR=0.630; 95% CI: 0.341, 1.165), node-positive disease (HR=0.771; 95% CI: 0.630, 0.944), pre-menopausal women and men (HR=0.722; 95% CI: 0.530, 0.983), post-menopausal women (HR=0.781; 95% CI: 0.613, 0.997)2. Ribociclib data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) (26% risk reduction) and recurrence-free survival (RFS) (28% risk reduction), with a trend for improvement in overall survival (OS) (HR=0.759; 95% CI: 0.539, 1.068).
For these previously announced results, median study duration of follow-up was 34 months (range 21-48 months) with clinical benefits observed after approximately two years2. NATALEE explored a lower starting dose (400 mg) of ribociclib than the dose approved for treatment in metastatic breast cancer (MBC) (600 mg) with the goal to minimize disruptions to patient quality of life without compromising efficacy. The safety profile of ribociclib at 400 mg was observed to have lower rates of symptomatic adverse events (AEs) and less need for dose modifications when administered up to three years. The most frequently reported AEs of special interest (grade 3 or higher) were neutropenia (43.8%) and liver-related AEs (e.G. Elevated transaminases) (8.3%).
More than 90% of patients diagnosed with breast cancer have EBC. Despite adjuvant ET, approximately one-third of those diagnosed with stage II and more than half of those diagnosed with stage III HR+/HER2- EBC experience cancer recurrence. The risk of recurrence continues over decades with more than half of breast cancer recurrences occurring five or more years after diagnosis. For many of these patients, there are currently no targeted therapeutic options outside of the standard chemotherapy and ET.
Kisqali has consistently demonstrated OS benefit while preserving or improving quality of life across three phase III trials in MBC. Updates to the NCCN Guidelines for breast cancer, released in January 2023, recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an aromatase inhibitor (AI). Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer22. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line.
Kisqali has been approved in 99 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission. In the US, Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist.
Novartis is committed to continuing to study Kisqali in breast cancer. Novartis is collaborating with SOLTI, which is leading the HARMONIA study to test whether Kisqali changes tumour biology to enable a better response to ET compared to Ibrance (palbociclib) for patients with HR+/HER2-, HER2-enriched subtype24 MBC, and with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant phase II trial studying the effects of Kisqali in HR+/HER2- EBC to discover the potentially unique underlying mechanism of action.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
Clinical Trials For Breast Cancer
Only about 3% of women with breast cancer take part in clinical trials, according to Y-ME, the national breast cancer organization.
This low level of clinical research participation may be stalling treatment progress. The fewer women who join clinical trials, the longer it takes to get data about whether a new treatment is an improvement over existing ones.
Should you join a breast cancer clinical trial? If you do, how can you choose the best one for you?
"Patients should be biased toward clinical trials," says Clifford Hudis, MD, Chief of the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center in New York. "If you [are seen at a medical] center and they have a trial for which you're appropriate, you should seriously consider it."
What are the advantages of participating in a clinical trial?
Does that mean that there are no down sides to participating in clinical trials? Of course not. "Any time you're trying a new treatment or one with which we have less experience, there's always some potential for greater risk," says Eric Winer, MD, director of the Breast Program at Boston's Dana-Farber Cancer Institute.
Potential negatives include:
You may think that if you're not being treated at a major, nationally known cancer center such as Sloan-Kettering or Dana-Farber, you won't have the opportunity to participate in clinical trials. Not true.
"Many smaller community hospitals and cancer centers have trials available to them, either on their own or as part of larger cooperative groups," says Winer.
Before signing up for a clinical trial, find out as much as possible about what's involved. Here are some important questions to ask, according to Clinicaltrials.Gov -- a web site sponsored by the National Institutes of Health:
Some of your best sources for finding clinical trials:
Remember, the current "gold standard" treatments that you're benefiting from now wouldn't be available if other women hadn't joined clinical trials.
"I don't think we can say this enough. By participating in a trial, women with breast cancer are adding to knowledge that will help countless other women in the future," says Winer.
Breast Cancer News
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