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PO.CT01.04 · 临床试验

Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study

海报缩略图：Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study
编号 CT262 展板 27 时间 4/21 02:00–05:00 区域 Section 50 主讲 Tomer Wasserman
分会场 Phase II Clinical Trials
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作者与单位

Hope S. Rugo1, Sara M. Tolaney2, Nancy Chan3, Giuliano Borges4, Rinat Yerushalmi5, Marina N. Sharifi6, Wassim McHayleh7, Thaddeus Beck8, Neelima Vidula9, Erika Hamilton10, Kristine J. Rinn11, Joyce O’Shaughnessy12, Giuseppe Curigliano13, Javier Cortés14, Paula Muñoz Romero15, Giulia Tonini15, Alessandro Paoli15, Monica Binaschi15, Li Cheng16, Jennifer A. Crozier16, Tomer Wasserman16, Virginia Kaklamani17

1City of Hope Cancer Center, Duarte, CA,2Dana-Farber Cancer Institute, Boston, MA,3NYU Langone Health, New York, NY,4Catarina Pesquisa Clínica, Santa Catarina, Brazil,5Rabin Medical Center, Petah Tikva, Israel,6University of Wisconsin, Madison, WI,7Adventhealth Cancer Institute, Orlando, FL,8Highlands Oncology, Springdale, AR,9Massachusetts General Hospital, Harvard Medical School, Boston, MA,10Sarah Cannon Research Institute, Nashville, TN,11Cancer Care Northwest, Spokane, WA,12Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX,13Istituto Europeo di Oncologia, IRCCS, and University of Milano, Milano, Italy,14International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Italy,15Menarini Group, Florence, Italy,16Menarini Group, New York, NY,17University of Texas Health Sciences Center San Antonio, San Antonio, TX

摘要 Abstract

Background: Disease progression in pts with ER+/HER2- mBC on 1L ET + CDK4/6i is associated with mechanisms of resistance that impact the efficacy of subsequent therapy. Ela improved PFS vs SOC ET ( ESR1 m tumors HR 0.55; 95% CI 0.39-0.77; all pts HR 0.70; 95% CI 0.55-0.88) with manageable safety in the Ph3 EMERALD trial (Bidard 2022). ELEVATE is evaluating Ela combined with Eve, alpelisib, capivasertib, Abema, ribociclib, or palbociclib to address resistance mechanisms. Based on encouraging Ph1b results, we evaluated Ph2 combinations of Ela + Eve or Abema in all pts and subgroups. Methods: Pts with ER+/HER2- mBC, 1-2L of prior ET are eligible regardless of ESR1 m status. Prior CDK4/6i is required for Arm B (Ela + Eve) and Arm C (Eve + Abema). Pts with no prior CDK4/6i were enrolled in Arm D (Ela + Abema). Ph2 evaluates PFS with each combination. ESR1 and PIK3CA mutation status were evaluated in pts for both combinations Ela + Eve (n=48) and Ela + Abema (n=50). Results: As of Sept 2025, 50 pts enrolled in Arm B (Ela + Eve), and 60 enrolled in Arms C and D (Ela + Abema combinations, n=30 each). Baseline characteristics are pts with visceral mets (72% Arm B, 92% Arms C/D), primary ET resistance (20% Arm B, 15% Arms C/D), ESR1 m (42% Arm B, 33% Arms C/D), and PIK3CA m (50% Arm B, 27% Arms C/D). PFS was consistent across subgroups (Table 1). Safety results were consistent with the known profiles of Eve or Abema + SOC ET. Ph2 Ela + Eve ORR was 19.5%, DCR 82.9%, mDOR 8.54 mo. Ph2 Ela + Abema ORR was 24.6%, DCR 91.2%, mDOR 14.75 mo. Conclusion: Ela combinations show a consistent clinically meaningful PFS irrespective of ESR1 m status in pts with ER+/HER2- mBC after progressive disease on ET ± prior CDK4/6i, and could become an ET backbone for combination strategies, supporting an all-oral approach. Table 1: Phase 2 mPFS, mo [95% CI] in all pts and subgroups (*Maturity not reached for PFS [95% CI]) Population Ela 345 mg QD + Eve 7.5mg QD (n=50) Ela 345 mg QD + Abema 150 mg BID (n=60) * All patients 8.3 [4.0 - 10.2] 14.3 [7.3 - 16.6] Visceral disease 7.7 [3.7 - 9.4] 14.3 [7.4 - 16.6] No prior fulvestrant 8.3 [4.2 - 12.9] 14.8 [8.7 - NR] No primary endocrine resistance 8.3 [4.0-12.9] 14.3 [7.3 - 16.6] ESR1m 8.3 [3.5 - 12.9] ESR1wt 9.0 [4.2 - 12.7] PIK3CAm 8.3 [3.6 - 10.2] PIK3CA wt 9.4 [4.0 - NR] NR, not reached * Maturity not reached for PFS (95% CI) for genomic subgroups ( ESR1 / PIK3CA ) or by prior CDK4/6i exposure.
利益披露 Disclosure
H. S. Rugo, Napo Pharmaceuticals, Bristol Meyer, Helsinn Therapeutics Consulting or Advisory Role. Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffmann-La Roche AG/Genentech, Inc, Stemline Therapeutics, Ambryx ). S. M. Tolaney, AADi; Ambrx; Artios Biopharmaceuticals; Arvinas; AstraZeneca; Bayer; BeiGene; Bicycle Therapeutics; BioNTech; Blueprint Medicines; Bristol-Myers Squibb; Circle Pharma; Cullinan Oncology; Daiichi Sank Other, Consulting or Advisory Role. eFFECTOR Therapeutics; Eisai; Genentech; Hengrui Pharmaceutical (USA); Immunomedics/Gilead; Incyte; Jazz Pharmaceuticals; Johnson & Johnson; Launch Therapeutics; Lilly; Menarini Group; Merck; Mersana Other, Consulting or Advisory Role. Natera; Novartis; Pfizer; Reveal Genomics; Sanofi; Seagen; Sumitovant Biopharma; Summit Therapeutics; Systimmune; Tango Therapeutics; Zentalis; Zuellig Pharma; Zymeworks Other, Consulting or Advisory Role. AstraZeneca (Inst); Bristol-Myers Squibb (Inst); Daiichi Sankyo; Eisai (Inst); Exelixis (Inst); Genentech/Roche (Inst); Gilead Sciences (Inst); Jazz Pharmaceuticals (Inst) ). Lilly (Inst); Menarini/Stemlin (Inst); Merck (Inst); NanoString Technologies (Inst); Novartis (Inst); OncoPep (Inst); Pfizer (Inst); Seagen (Inst) ). Arvinas; Gilead Sciences; Jazz Pharmaceuticals; Lilly; Pfizer; Sanofi Travel. N. Chan, Daiichi Sankyo/Astra Zeneca; Novartis Other, Honoraria. Daiichi Sankyo Other, Consulting or advisory role. Merck ). G. Borges, None. R. Yerushalmi, AstraZeneca; Gilead Sciences; Lilly; Novartis; Pfizer; Rhenium Medical; Roche Other, Consulting or Advisory Role. Roche (Inst) ). M. N. Sharifi, Novartis (inst) ). W. McHayleh, AstraZeneca; Daiichi Sankyo/Astra Zeneca; Genentech; Gilead Sciences; Lilly; Natera Other, Consulting or Advisory Role. Agendia; AstraZeneca; Daiichi Sankyo/Astra Zeneca; Gilead Sciences; Lilly; Merck; Natera; Pfizer; Stemline Therapeutics Other, Speakers' Bureau. T. Beck, AbbVie (Inst); Amgen (Inst); AstraZeneca (Inst); DSi (Inst); Lilly (Inst); Nektar (Inst); Nektar (Inst); Novartis (Inst); Pfizer (Inst); Seattle Genetics/Astellas (Inst) ). N. Vidula, Daiichi; IDEOlogy Health; Novartis; Stemline Therapeutics Other, Consulting or Advisory Role. DAEHWA Pharmaceutical (Inst); Merck (Inst); Novartis (Inst); Pfizer (Inst); Radius Health (Inst); Stemline Therapeutics (Inst) ). E. Hamilton, Accutar Biotechnology (Inst); Arvinas (Inst); AstraZeneca (Inst); Circle Pharma (Inst); Daiichi Sankyo (Inst); Ellipses Pharma (Inst); Entos (Inst); Fosun Pharma (Inst); Genentech/Roche (Inst) Other, Consulting or Advisory Role. Gilead Sciences (Inst); Janssen (Inst); Jazz Pharmaceuticals (Inst); Jefferies (Inst); Johnson and Johnson (Inst); Lilly (Inst); Medical Pharma Services (Inst); Mersana (Inst); Novartis (Inst); Olema Other, Consulting or Advisory Role. fizer (Inst); Stemline Therapeutics (Inst); Tempus (Inst); Theratechnologies (Inst); Tubulis GmbH (Inst); Verascity Science (Inst); Zentalis (Inst) Other, Consulting or Advisory Role. Abbvie (Inst); Accutar Biotech (Inst); Acerta Pharma (Inst); ADC Therapeutics (Inst); Akeso Biopharma (Inst); Amgen (Inst); Aravive (Inst); ArQule (Inst); Artios (Inst); Arvinas (Inst); AstraZeneca ). AtlasMedx (Inst); BeiGene (Inst); Black Diamond Therapeutics (Inst); Bliss Biopharmaceutical (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squib (Inst); Cascadian Therapeutics (Inst); Clovis Onc ). Compugen (Inst); Context Therapeutics (Inst); Cullinan Oncology (Inst); Curis (Inst); CytomX Therapeutics (Inst); Daiichi Sankyo (Inst); Dana Farber Cancer Hospital (Inst); Dantari (Inst); Deciphera ). Duality Biologics (Inst); eFFECTOR Therapeutics (Inst); Eisai (Inst); Ellipses Pharma (Inst); Elucida Oncology (Inst); EMD Serono (Inst); Fochon Pharmaceuticals (Inst); Fujifilm (Inst); G1 Therapeuti ). Genentech/Roche (Inst); Gilead Sciences (Inst); H3 Biomedicine (Inst); Harpoon (Inst); Hutchison MediPharma (Inst); Immunogen (Inst); Immunomedics (Inst); Incyte (Inst); Infinity Pharmaceuticals (In ). Inspirna (Inst); InventisBio (Inst); Jacobio (Inst); K-Group Beta (Inst); Karyopharm Therapeutics (Inst); Kind Pharmaceuticals (Inst); Leap Therapeutics (Inst); Lilly (Inst); Loxo (Inst); Lycera (Ins ). MabSpace Biosciences (Inst); Macrogenics (Inst); MedImmune (Inst); Mersana (Inst); Merus (Inst); Millennium (Inst); Molecular Templates (Inst); Myriad Genetics (Inst); Novartis (Inst); Nucana (Inst); ). Olema Pharmaceuticals (Inst); OncoMed (Inst); Oncothyreon (Inst); ORIC Pharmaceuticals (Inst); Orinove (Inst); Orum Therapeutics (Inst); Pfizer (Inst); PharmaMar (Inst); Pieris Pharmaceuticals (Inst) ). Pionyr (Inst); Plexxikon (Inst); Prelude Therapeutics (Inst); ProfoundBio (Inst); Radius Health (Inst); Regeneron (Inst); Relay Therapeutics (Inst); Repertoire Immune Medicines (Inst); Rgenix (Inst); ). Sermonix Pharmaceuticals (Inst); Shattuck Labs (Inst); Silverback Therapeutics (Inst); Stem CentRx (Inst); Stemline Therapeutics (Inst); Sutro Biopharma (Inst); Syndax (Inst); Syros Pharmaceuticals ( ). Taiho Pharmaceutical (Inst); TapImmune Inc. (Inst); Tesaro (Inst); Tolmar (Inst); Torque (Inst); Treadwell Therapeutics (Inst); Verastem (Inst); Zenith Epigenetics (Inst); Zymeworks (Inst) ). K. J. Rinn, None. J. O’Shaughnessy, AADi; Agendia; Amgen; Aptitude Health; AstraZeneca; BioNTech; Bristol-Myers Squibb; Daiichi Sankyo; DAVA Oncology; DualityBio; Eisai; Ellipses Pharma; Exact Sciences; G1 Therapeutics; Genentech; Other, Honoraria. Gilead Sciences; Guardant Health; HiberCell; Jazz Pharmaceuticals; Johnson & Johnson; Lilly; Menarini Group; Merck; Mersana; Natera; Novartis Other, Honoraria. Pfizer; Pierre Fabre; Puma Biotechnology; Roche; Sanofi; Seagen; Stemline Therapeutics; Summit Therapeutics; Tempus; Tersera Other, Honoraria. AADi; Agendia; Amgen; Aptitude Health; AstraZeneca; BioNTech; Bristol-Myers Squibb; Daiichi Sankyo; DAVA Oncology; DualityBio; Eisai Other, Consulting or advisory role. Ellipses Pharma; Exact Sciences; G1 Therapeutics; Genentech; Gilead Sciences; Guardant Health; HiberCell; Jazz Pharmaceuticals; Johnson & Johnson; Lilly; Menarini Group; Merck; Mersana Other, Consulting or advisory role. Natera; Novartis; Pfizer; Pierre Fabre; Puma Biotechnology; Roche; Sanofi; Seagen; Stemline Therapeutics; Summit Therapeutics; Tempus; Tersera Other, Consulting or advisory role. Aptitude Health; Daiichi Sankyo; DAVA Oncology; Lilly; Merck; Novartis; Roche Travel. G. Curigliano, ESMO; ESMO Open; European Society of Breast Cancer Specialist Other, Leadership. Ellipses Pharma Other, Honoraria. AstraZeneca; Blueprint Medicines; Boehringer Ingelheim; Bristol-Myers Squibb; Celcuity; Daichi-Sankyo; Exact Sciences; Foundation Medicine; Gilead Sciences; GlaxoSmithKline; Guardant Health; Hengrui Other, Consulting or advisory role. Lilly; Menarini; Merck; Novartis; Pfizer; Roche/Genentech; Samsung; Seagen; Veracyte Other, Consulting or advisory role. AstraZeneca; Daiichi Sankyo; Exact Sciences; Foundation Medicine; Gilead Sciences; Lilly; Menarini; Novartis; Pfizer; Roche/Genentech; Samsung; Seagen Other, Speaker's Bureau. Merck (Inst) ). AstraZeneca; Daichii Sankyo; Pfizer; Roche/Genentech Travel. J. Cortés, Leuko (I); MAJ3 Capital Stock. AstraZeneca; Celgene; Daiichi Sankyo; Eisai; Gilead Sciences; Lilly; Merck Sharp & Dohme; Novartis; Pfizer; Roche; Samsung; Steamline Therapeutics Other, Honoraria. Abbvie; AstraZeneca; Athenex; Bioasis; Biocon; Bioinvent; BioNTech SE; Boehringer Ingelheim; Bridgebio; Celgene; Cellestia Biotech; Circle Pharma; Clovis Oncology; Daiichi Sankyo; Delcath System Other, Consulting or Advisory Role. Ellipses Pharma; ERYTECH Pharma; Expres2ion Biotechnologies; GEMoaB; Gilead Sciences; GlaxoSmithKline; Hexagon Bio; HiberCell; Jazz Pharmaceuticals; Leuko; Lilly; Menarin Other, Consulting or Advisory Role. Merck Sharp & Dohme; Polyphor; Reveal Genomics; Roche; Seagen; SERVIER; Zymeworks Other, Consulting or Advisory Role. ARIAD (Inst); Astrazeneca (Inst); Baxalta (Inst); Bayer (Inst); Eisai (Inst); Guardant Health (Inst); Merck Sharp & Dohme (Inst); Pfizer (Inst); Piqur (Inst); Puma Biotechnology (Inst) ). Queen Mary university of London (Inst); Roche (Inst) ). AstraZeneca; Daiichi Sankyo; Eisai; Gilead Sciences; Merck Sharp&Dhome; Novartis; Pfizer; Roche; Steamline Therapeutics Travel. P. M. Romero, Menarini Group Employment. G. Tonini, Menarini Group Employment. A. Paoli, Menarini Group Employment. M. Binaschi, Menarini Group Employment. L. Cheng, Menarini Group Employment. J. A. Crozier, Menarini Group Employment. T. Wasserman, Menarini Group Employment. V. Kaklamani, AstraZeneca; daichi; Genentech; Gilead Sciences; Novartis; Pfizer; Puma Biotechnology; Seagen Other, Honoraria. AstraZeneca; Daiichi Sankyo/UCB Japan; Lilly; Menarini; Puma Biotechnology; tersera Other, Consulting or advisory role. AstraZeneca/Daiichi Sankyo; Gilead Sciences; Novartis; Pfizer Other, Speaker's bureau. Eisai ).

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