240P - Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in older patients (pts) with HR+/HER2− early breast cancer (EBC) in NATALEE

Background

In NATALEE, RIB + NSAI yielded a statistically significant benefit in invasive disease-free survival (iDFS, using STEEP criteria by investigator assessment) vs NSAI alone (hazard ratio [HR], 0.749; 95% CI, 0.628-0.892; P=.0006) in a broad age range of pts with HR+/HER2− EBC. We report outcomes with RIB + NSAI in older pts (≥65 y).

Methods

Pts were treated with RIB + NSAI or NSAI alone. Efficacy, safety, and quality of life were assessed in pts ≥65 vs <65 y (data cutoff: July 21, 2023).

Results

Of 5101 pts in NATALEE, 773 (15.2%) were ≥65 and 4328 (84.8%) were

Conclusions

RIB + NSAI showed similar benefit regardless of age, with no new safety signals. The rate of RIB discontinuation without dose reduction in older pts highlights an opportunity to optimize AE management. These results further support RIB efficacy and tolerability in pts with HR+/HER2− EBC regardless of age.

Clinical trial identification

NATALEE: CLEE011O12301C, The release date is: NATALEE: 2018-09-21.

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

M. Untch: Financial Interests, Institutional, Advisory Board, Advisory board, lectures; all fees and honoraria to the employer/institution: AstraZeneca, Amgen, Daiichi Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Seagen, Pierre Fabre, Sanofi Aventis, Myriad, Gilead, Novartis, Stemline, Genzyme, Medac. D. Yardley: Financial Interests, Institutional, Research Grant, Research Funding to Institution: Ambrx, Amgen, AstraZeneca, Biomarin, Biothera Pharmaceuticals, Clovis Pharma, Dana Farber Cancer Institute, Lilly, Roche/Genentech, G1 Therapeutics, Gilead Therapeutics, Incyte, Innocrin Pharmaceuticals, MacroGenics, MedImmune, Medivation, Merck, Merrimac; Financial Interests, Institutional, Advisory Board, Consulting/Advisory Role (Payment to inst): AstraZeneca, G1 Therapeutics, Gilead Sciences, Immunomedics, Integra Connect, Novartis, Sanofi-Aventis, Stemline Therapeutics. S. Im: Financial Interests, Personal, Advisory Board, no payment: AstraZeneca, Novartis, Eisai, Roche, Hanmi, Pfizer, Lilly, MSD, GSK, Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Bertis; Financial Interests, Personal, Advisory Board: Idience; Financial Interests, Institutional, Research Grant: AstraZeneca, Pfizer, Roche, Eisai, Dae Woong; Financial Interests, Institutional, Local PI, Clinical Trial Budget: AstraZeneca, Hanmi, Novartis, Roche, Pfizer, Daiichi Sankyo, MSD, Lilly; Financial Interests, Institutional, Coordinating PI, Clinical Trial Budget: Eisai; Financial Interests, Institutional, Research Grant, Clinical Trial Budget: Boryung Pharm. T. Pluard: Financial Interests, Personal and Institutional, Research Grant: Novartis, Pfizer, Scorpion Therapeutics, Gilead, AstraZeneca, Sermonix, Carrick; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Speaker, Consultant, Advisor: Gilead, Stemline, AstraZeneca. L. Hart: Financial Interests, Institutional, Research Grant, Research support for my institution: Novartis; Financial Interests, Personal, Speaker’s Bureau, 2019 Speaker's Bureau: Novartis. J.P. Crown: Financial Interests, Personal, Other: Pierre Fabre, Novartis, AstraZeneca, Regeneron, Immunocore; Other, Personal, Other, Travel support to meetings: Novartis, MSD Oncology, Pfizer, Roche, AstraZeneca, Regeneron; Financial Interests, Personal, Stocks/Shares: Oncoassure, Akkure; Other, Personal, Other, WO2020011770 (A1) - A method of predicting response to treatment in cancer patients: Pending Patent. C. Zamagni: Financial Interests, Personal, Advisory Board: Roche, EISAI, Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Exact Sciences, MSD, GSK, Gilead, Seagen; Financial Interests, Institutional, Local PI: Roche, Novartis, AstraZeneca, Pfizer, Seagen, Medivation, AbbVie, Array BioPharma, Morphotek, Synthon, Daichii-Sankyo, MSD, GSK, Gilead; Financial Interests, Personal, Other, Member of an Independent Data Monitoring Committee for an international clinical trial: AstraZeneca; Non-Financial Interests, Other, member of the Scientific Committee: LOTO Onlus, Susan J Komen Emilia-Romagna, Mamazone Sudtirol; Other, travel accomodation and partecipation expenses for scientific congresses: Roche, Novartis, Pfizer, Daichii-Sankyo, MSD, GSK, Gilead, AstraZeneca. I. Blancas López-Barajas: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Eisai, Gilead, Grünenthal, GSK, Lilly, MSD, Novartis, Pfizer, Pierre-Fabre, Roche, Seagen; Financial Interests, Personal, Other, Medical monitor: Medical Science Innovation Research (MEDSIR); Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Roche, Agendia; Financial Interests, Institutional, Research Grant: Pfizer; Other, Support for attending meetings and/or travel: AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Gilead, Lilly, Novartis, Pfizer, Roche, Pierre Fabre. F. Parnizari: Other, Personal and Institutional, Other, Translational Research In Oncology is contracted by Novartis as CRO conducting the NATALEE trial.: Novartis. M. Gao; K. Amin; H. Hu: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal and Institutional, Stocks or ownership: Novartis. H.S. Rugo: Financial Interests, Personal, Advisory Board, Consultancy/advisory support: NAPO; Financial Interests, Personal, Invited Speaker, Honoraria: Mylan/Viatris, Chugai; Financial Interests, Personal, Advisory Board, Advisory/Consultancy: PUMA, Sanofi; Financial Interests, Institutional, Local PI: Novartis, Lilly, Pfizer, Daiichi, AstraZeneca, Gilead Sciences, Inc.; Financial Interests, Institutional, Coordinating PI: OBI Pharma, F. Hoffmann-La Roche AG/Genentech, Inc., Merck; Financial Interests, Institutional, Research Grant: Stemline Therapeutics, Ambryx. All other authors have declared no conflicts of interest.