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ASCO 2025 | NATALEE: ribociclib outcomes by menopausal status & age in breast cancer

Kevin Kalinsky, MD, MS, Emory University Hospital, Atlanta, GA, discusses subgroup outcomes from the NATALEE trial (NCT03701334), which assessed ribociclib and nonsteroidal aromatase inhibitor (NSAI) in patients with stage II/III HR+/HER2− early breast cancer. Consistent invasive disease–free survival benefit was observed across menopausal and age groups. Premenopausal women, who presented with more aggressive disease features, derived notable benefit and had lower treatment discontinuation due to adverse events. Quality of life outcomes remained comparable between treatment arms, supporting the broad applicability of this regimen across diverse patient populations. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

At the rapid oral session here at ASCO 2025, we reported updates from the NATALEE trial. We looked at menopausal status and we also looked at age and gave updates. Previously, we’d seen data with a median follow-up of around 33 months. Now we presented data with a median follow-up of 44 months. What we saw is that in patients in NATALEE against stage 2-3, hormone receptor positive or triple negative disease, we ended up seeing that patients continue to have this persistent benefit even after stopping ribociclib...

At the rapid oral session here at ASCO 2025, we reported updates from the NATALEE trial. We looked at menopausal status and we also looked at age and gave updates. Previously, we’d seen data with a median follow-up of around 33 months. Now we presented data with a median follow-up of 44 months. What we saw is that in patients in NATALEE against stage 2-3, hormone receptor positive or triple negative disease, we ended up seeing that patients continue to have this persistent benefit even after stopping ribociclib. And that absolute benefit with ribociclib only continues to increase, and it was increased in premenopausal patients as well as postmenopausal patients. And then we looked by subgroups, in particular patients, for instance, who were less than 40 years of age because we know that these patients can be at a higher risk for recurrence. We saw, regardless of age, that there was a benefit that was seen with the addition of ribociclib. We also looked at quality of life outcomes with the QLQ-C30, and we saw that there was no additional quality of life impact by taking ribociclib. So ultimately, the data demonstrated that across different endpoints, whether it’s invasive disease-free survival, distant relapse-free survival, et cetera, that ribociclib is helping regardless of age in subgroup.

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Disclosures

Employment – EQRx (I)
Stock and Other Ownership Interests – EQRx (I)
Consulting or Advisory Role – AstraZeneca; bioTheranostics; Cullinan Oncology; Daiichi Sankyo/Astra Zeneca; eFFECTOR Therapeutics; Genentech/Roche; Gilead Sciences; Lilly; Menarini Silicon Biosystems; Merck; mersana; Mersana; Myovant Sciences; Novartis; Pfizer; Prelude Therapeutics; ProteinQure; Puma Biotechnology; RayzeBio; Regor; Relay Therapeutics; Takeda
Research Funding – Ascentage Pharma (Inst); AstraZeneca (Inst); Daichi Sankyo (Inst); Genentech/Roche (Inst); Lilly (Inst); Novartis (Inst); Seagen (Inst)