Found 1 Presentation For Request "272TiP"
272TiP - HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)
- Tomas Pascual (Barcelona, Spain)
Abstract
Background
RIB and PAL are CDK4/6 inhibitors with efficacy and tolerability in pts with HR+/HER2- ABC when administered in combination with endocrine therapy (ET). RNA-based intrinsic subtyping has strong prognostic and predictive value in advanced HR+/HER2- tumors treated with ET. Non-Luminal subtypes, such as HER2-E and basal-like, are relatively endocrine-resistant and have poorer prognosis than luminal. tumors can switch subtypes over time to a more aggressive and less endocrine-responsive biology, which may also be reversed by effective treatment. A pooled retrospective analysis of MONALEESA 2/3/7 trials showed that HER2-E tumors had surprising benefit from RIB treatment, while basal-like tumors did not. Pre/clinical data suggest that RIB may outperform PAL in HER2-E. HARMONIA seeks to identify the best therapeutic option between RIB and PAL for pts with HR+/HER2-/HER2-E ABC and aims to test whether RIB changes tumor biology thus enabling better response to ET and improving the disease course. In addition, it explores the value of earlier treatment with chemotherapy in pts with basal-like tumors.
Trial design
This is an international, multicenter, randomized, open-label, phase III study, using prospective pre-selection based on tumor biology in pts with HR+ (ER<100%)/HER2- ABC, with HER2-E tumors (main cohort 456 pts) and with basal-like tumors (exploratory cohort ∼60 pts). Pts with HER2-E tumors will be randomized 1:1 to RIB+ET (letrozole or fulvestrant) or PAL+ET. In the basal-like cohort, pts will be treated with paclitaxel. Primary endpoint (EP): progression-free survival (PFS) per RECIST v1.1 by investigator-assessment. Secondary EP: overall survival, PFS2, clinical benefit rate, duration and time to response, quality of life, and exploratory EP, including subtype switching between primary and metastatic tumor, and after trial treatment. Primary EP final analysis will be performed after 310 PFS events are observed (∼80% power using one-sided 5% α). HARMONIA will recruit in Spain (40 sites), Portugal (5), and US (35) within SOLTI & AFT network.
Clinical trial identification
EudraCT: 2021-002027-38. NCT05207709, Initial Release: 01/04/2022.
Legal entity responsible for the study
SOLTI innovative cancer research.
Funding
Novartis Pharma AG.
Disclosure
T. Pascual: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Lilly. D.G. Stover: Financial Interests, Personal, Advisory Board, One-time 11/2021: Novartis. A. Thuerigen: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. C.M. Perou: Financial Interests, Personal, Advisory Role: Bioclassifier, Veracyte.; Financial Interests, Personal, Stocks/Shares: Bioclassifier. E.M. Ciruelos: Financial Interests, Personal, Other, Speakers Bureau. Educational activities: Roche; Financial Interests, Personal, Invited Speaker, Symposia and Educational activities: Roche; Financial Interests, Personal, Advisory Board, Non-permanent advisor: Roche, Lilly, Novartis, Pfizer, Daiichi Sankyo, MSD; Financial Interests, Personal, Invited Speaker, Symposia and Education: Lilly; Financial Interests, Personal, Invited Speaker, Educational activities: Pfizer; Financial Interests, Personal, Advisory Board, Non-permanent advisor, Travel accommodation: AstraZeneca; Financial Interests, Personal, Other, Advisory Board: Gilead; Financial Interests, Personal, Other, Advisory Board, Invited speaker: Seagen; Financial Interests, Institutional, Funding, PI for Patricia 2 trial (sponsor: SOLTI Group): Pfizer; Financial Interests, Institutional, Funding, PI for Prometeo 2 trial (sponsor: SOLTI Group): Pfizer; Financial Interests, Institutional, Funding, PI for TATEN trial (sponsor: SOLTI Group): MSD; Financial Interests, Institutional, Funding, PI for ATREZZO trial (sponsor: SOLTI Group): Roche; Non-Financial Interests, Invited Speaker, Non-profit organization dedicated to breast cancer research: SOLTI Cooperative Group; Non-Financial Interests, Advisory Role, Scientific Evaluator at ISCIII (Spanish Government Academic Research Platform): Instituto de Salud Carlos III. P. Spears: Financial Interests, Personal, Advisory Board, Advisory Committees on real world evidence and the patient voice.: Pfizer, Inc. E. Roux: Financial Interests, Personal, Full or part-time Employment, Novartis Precision Medicine Lead Med Affairs: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. Y. Lu: Financial Interests, Personal, Advisory Board: Novartis, Eli Lilly, MSD, Advisory Board; Financial Interests, Personal, Invited Speaker: Novartis, Roche, Pfizer, MSD, Eli Lily, Eisai, Other; Financial Interests, Institutional, Principal Investigator: Novartis, Roche, Pfizer, MSD, Eli Lily, Eisai, Odonate, Local PI; Non-Financial Interests, Leadership Role, Chair or co-chair of steering committee of clinical trials: Novertis. S.M. Tolaney: Financial Interests, Personal, Advisory Board, Ad Board Participant/Consultant: AstraZeneca, Eli Lilly; Financial Interests, Personal, Advisory Board, Ad board participant/Consultant: Pfizer; Financial Interests, Personal, Advisory Board, Ad board participant/consultant: Novartis, Gilead, Genentech/Roche, Eisai, Sanofi, SeaGen, Daichii Sankyo, 4D Pharma, Puma, ARC Therapeutics; Financial Interests, Personal, Advisory Board, Ad Board participant/consultant: Merck; Financial Interests, Personal, Other, Consultant: Nektar, Nanostring, Athenex, Blueprint Medicines; Financial Interests, Personal, Advisory Board, Ad board participant: Bristol-Myers Squibb, OncoPep, OncoSec, Certara, Mersana Therapeutics, Ellipses Pharma; Financial Interests, Personal, Advisory Board, Ad board participant/consultant/DSMC: Odonate; Financial Interests, Personal, Other, Steering Committee Member/Consultant: CytomX; Financial Interests, Personal, Invited Speaker, Invited speaker for pharma supported educational activity: Chugai Pharmaceuticals; Financial Interests, Personal, Advisory Board, Advisory board participant: G1 Therapeutics; Financial Interests, Personal, Advisory Board, Advisory Board Participation: Zymeworks; Financial Interests, Personal, Advisory Board, Advisory Board participation: Zentalis, OncXerna; Financial Interests, Personal, Advisory Board, Advisory board participation: Reveal Genomics; Financial Interests, Institutional, Funding: AstraZeneca, Eli Lilly, Pfizer, Sanofi, SeaGen, Odonate, Cyclacel, Exelixis, Gilead, Bristol Myers Squibb, Eisai, Merck, Novartis, Nektar, Genentech/Roche; Financial Interests, Personal and Institutional, Invited Speaker: CytomX. A. Partridge: Financial Interests, Personal, Royalties, Royalties received for authorship of Breast Cancer Survivorship section: UpToDate; Non-Financial Interests, Leadership Role, co-Chair of Breast Committee: Alliance for Clinical Trials, National Cancer Institute; Non-Financial Interests, Other, Board of Directors, Member 2022-2026: ASCO. G. Villacampa Javierre: Financial Interests, Personal, Invited Speaker, Invited speaker in a course: MSD; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker, Invited speaker in an internal training: Pierre Fabrer, GSK. L. Carey: Financial Interests, Personal, Royalties, immediate family member-royalty-sharing agreement, investorship interest in licensed IP to startup company, Falcon Therapeutics, that is designing neural stem cell-based therapy for glioblastoma multiforme.: Falcon Therapeutics; Financial Interests, Institutional, Funding, research funding: Syndax, Immunomedics, Novartis, Nanostring Technologies, Abbvie, Seattle Genetics, Veracyte; Non-Financial Interests, Advisory Role, uncompensated relationship - all monies go to UNC. Dr. Carey does not have any signatory authority over any UNC account: sanofi, Novartis, G1 Therapeutics, Genentech/Roche, GlaxoSmithKline, AstraZeneca/ Daiichi Sankyo, Apitude Health, Exact Sciences. A. Prat: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis, Daiichi Sankyo; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis, Pfizer, BMS, Puma, Oncolytics Biotech, MSD, Guardant Health, Peptomyc; Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo; Financial Interests, Institutional, Other, Contracted research: Boehringer, Medica Scientia inno. Research; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker, Leadership role: Reveal Genomics, SL.; Financial Interests, Personal, Stocks/Shares: Reveal Genomics, Oncolytics Biotech; Financial Interests, Personal, Royalties: Reveal Genomics; Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Daiichi Sankyo; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation. All other authors have declared no conflicts of interest.