235MO - Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in younger patients (pts) with HR+/HER2− early breast cancer (EBC) in NATALEE

Background

NATALEE showed a statistically significant invasive disease–free survival (iDFS) benefit of RIB + NSAI vs NSAI alone (hazard ratio [HR] 0.749; 95% CI, 0.628-0.892; P=.0006) in pts with HR+/HER2− EBC. We report RIB efficacy/safety in pts <40 vs ≥40 y in NATALEE.

Methods

Pts were treated with RIB + NSAI or NSAI alone. Premenopausal pts also received goserelin. Efficacy/safety/pt-reported outcomes were assessed in pts <40 vs ≥40 y (data cutoff: Jul 21, 2023; median follow-up, 36.7 mo).

Results

Of 5101 pts, 543 (10.6%; RIB + NSAI, 250) were

Conclusions

Adjuvant RIB + NSAI showed treatment benefit in pts with HR+/HER2− EBC, including in pts <40 y, who had more aggressive disease than pts ≥40 y. Although safety profiles were consistent between age groups, pts <40 y were less likely to discontinue RIB due to AEs and were less likely to do so without prior dose reduction.

Clinical trial identification

The trial protocol number is: NATALEE: CLEE011O12301C The release date is: NATALEE: 2018-09-21 (date first submitted to CT.gov).

Editorial acknowledgement

Editorial assistance in the writing of the abstract was provided by Molly Amador, PhD of Nucleus Global.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

S. Loi: Financial Interests, Institutional, Advisory Board, Consultant: AstraZeneca, Novartis, Roche Genentech; Financial Interests, Institutional, Advisory Board, Consultant: BMS; Financial Interests, Institutional, Advisory Board, consultant: Daiichi Sankyo, Eli Lilly, Gilead Sciences, Merck; Financial Interests, Personal, Advisory Board: Novartis, AstraZeneca, BMS, Amaroq Therapeutics, Mersana Therapeutics, Domain Therapeutics; Financial Interests, Institutional, Funding, Research: Novartis, BMS, Merck, PUMA Biotechnology, Eli Lilly, Nektar Therapeutics, AstraZeneca, Seattle Genetics, Roche - Genentech; Non-Financial Interests, Advisory Role, Consultant (Non remunerated): Seattle Genetics, Novartis, Bristol Myers Squibb, Merck, AstraZeneca, Roche Genentech; Non-Financial Interests, Advisory Role, consultant (not compensated): Eli Lilly, Gilead Therapeutics. J. Frenel: Financial Interests, Personal, Advisory Board: Pfizer, Novocure, Pierre Fabre, Eisai, Seagen, Gilead; Financial Interests, Personal, Invited Speaker: GSK, Amgen, Eisai; Financial Interests, Institutional, Advisory Board: Exactscience, Lilly, Daiichi Sankyo, AstraZeneca, Clovis Oncology; Financial Interests, Institutional, Invited Speaker: Novartis, MSD; Financial Interests, Coordinating PI: AstraZeneca, Seagen; Financial Interests, Local PI: MSD, Daiichi Sankyo; Non-Financial Interests, Principal Investigator: Novartis, Lilly, AstraZeneca, Pfizer, Daiichi Sankyo, MSD. M. Reinisch: Financial Interests, Other, Personal fees: Novartis, Roche, MSD, Lilly, AstraZeneca, Seagen, Pfizer, Somatex, Gilead, Daiichi Sankyo; Non-Financial Interests, Other, Non-Financial Interests: Novartis, Roche, Lilly, AstraZeneca, Gilead, Daiichi Sankyo. R. ORegan: Financial Interests, Personal, Advisory Role: PUMA, Pfizer; Financial Interests, Personal and Institutional, Research Funding, Grant Funding: PUMA. M. De Laurentiis: Financial Interests, Personal, Advisory Board, Advisory Board Honoraria: Pfizer, Novartis, Roche, Celgene, AstraZeneca, Eisai, Eli Lilly, MSD, Pierre Fabre, Exact Science, Daiichi Sankyo, Gilead, Seagen, Menarini-Stemline, Vercyte, Takeda, Ipsen; Financial Interests, Personal, Speaker’s Bureau, Speaker's Honoraria: Pfizer, Novartis, Roche, Celgene, AstraZeneca, Eisai, Eli Lilly, MSD, Pierre Fabre, Exact Science, Daiichi Sankyo, Gilead, Seagen, Menarini-Stemline, Vercyte, Takeda, Ipsen. Y.H. Park: Financial Interests, Personal, Advisory Board: AstraZeneca, Pfizer, Roche, Novartis, MSD, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, Roche, Novartis, MSD, Daiichi Sankyo; Financial Interests, Institutional, Other, Research Grant: AstraZeneca, Pfizer, Roche, MSD; Financial Interests, Institutional, Writing Engagement: Pfizer; Non-Financial Interests, Principal Investigator: AstraZeneca, Pfizer, Novartis, MSD, Lilly, Roche, Daiichi Sankyo. Y. Lu: Financial Interests, Personal, Advisory Board: Novartis, Eli Lilly, MSD, Roche, Pfizer, AstraZeneca, Eisai, Daiichii Sankyo, Gilead; Financial Interests, Personal, Invited Speaker: Novartis, Eli Lilly, MSD, Roche, Pfizer, AstraZeneca, Eisai, Daiichii Sankyo, Gilead; Financial Interests, Institutional, Local PI: Novartis, Roche, Pfizer, MSD, Eli Lily, Eisai, AstraZeneca, Gilead, Jellox; Non-Financial Interests, Leadership Role, Chair or co-chair of steering committee of clinical trials: Novartis; Non-Financial Interests, Advisory Role: AstraZeneca. V. Gonzalez: Other, Personal and Institutional, Other, Translational Research In Oncology is contracted by Novartis as CRO conducting the NATALEE trial.: Novartis. M. Gao: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal and Institutional, Stocks or ownership: Novartis. S. Waters: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal and Institutional, Stocks or ownership: Novartis. H. Hu: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal and Institutional, Stocks or ownership: Novartis. B. Xu: Financial Interests, Personal, Advisory Role, Advisory Fees: Novartis, AstraZeneca. All other authors have declared no conflicts of interest.