387MO - First results of the SOLTI-1903 HOPE's patient-centric molecular screening program in advanced breast cancer

Background

The SOLTI-1903 HOPE study aims to assess the feasibility of a molecular screening program promoting active participation of patients with Advanced Breast Cancer (ABC) in the management of their disease to better characterize the genomic landscape of ABC and to facilitate pt access to matched-targeted therapies in Spain.

Methods

HOPE (NCT04497285) is a patient-centric study where pts diagnosed with ABC lead their inclusion, participation, and follow-up through a digital tool (DT). They report clinical information and provide archival tumor samples to be analyzed by FoundationOne CDx. At progression disease, patients undergo a liquid biopsy with the Guardant360 panel. Clinical and genomic information is discussed by a Molecular Advisory Board (MAB) that issues a report explaining the alterations and enumerating potentially useful targeted treatments. Then, participants record disease evolution in the DT for 2y. The primary objective is to assess the real-world clinical practice of integrating molecular profiling into the Standard of Care management of pts with ABC.

Results

Between Oct 2020 and Feb 2022, 604 patients were included in the study, and the median age was 51 ys (range 27-82y). The most common reported IHC subtype was ER+/HER2- (74%), followed by HER2+ (14%) and triple negative (12%). 512 tumor samples were received from 423 patients, and DNA-seq results with positive results were obtained in 298 (58%) cases. Common alterations were PIK3CA mut (34%), CCND1 amp (27%), and TP53 mut (26%). Blood extractions were obtained from 378 patients, and ctDNA detection was observed in 303 (80%) cases. Frequently mutated genes were PIK3CA (38%), TP53 (38%), and ESR1 (29%). As of April 2023, the MAB reviewed 306 cases, observing at least one ESCAT I-III alteration in 75% of cases. Of these, only 15% were already known before HOPE. After a mean follow-up of 1.3ys, 20% of ABC cases discussed received a targeted treatment.

Conclusions

Patient-centric molecular screening programs implemented on a nationwide level are viable, have the potential to impact treatment decisions in a subgroup of patients and seems more efficient to bring patients to receive treatments targeted to the identified alterations.

Clinical trial identification

NCT04497285.

Editorial acknowledgement

Legal entity responsible for the study

SOLTI Cancer Research Group.

Funding

Novartis; Roche (Foundation Medicine); Guardant Health; Asociación española de Cáncer de Mama Metastásico; Fundación Actitud Frente al Cáncer; Saray (Asociación Navarra de Cáncer de Mama); Federación Española de Cáncer de Mama (FECMA); Asociación Vive, "Ni una estrella más"; Manualitats Solidàries Cerdanyola.

Disclosure

T. Pascual: Financial Interests, Personal, Invited Speaker: Pfizer/ AstraZeneca / Veracyte / Novartis; Financial Interests, Personal, Advisory Board: Roche/Genentech, Novartis. E. Segui Solis: Financial Interests, Personal, Invited Speaker: Novartis, Veracyte, Pfizer; Financial Interests, Personal, Full or part-time Employment: SOLTI; Financial Interests, Personal, Research Grant: Amgen. R. Olivera-Salguero: Financial Interests, Personal, Full or part-time Employment: SOLTI. J.M. Cejalvo: Financial Interests, Personal, Advisory Board: Novartis, Pfizer. M. Oliveira: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo / AstraZeneca, Gilead, Pierre Fabre, Roche, SeaGen, iTEOS, Relay Therapeutics; Financial Interests, Personal, Invited Speaker: Gilead, MSD, Novartis, Pfizer, Roche, Seattle Genetics; Financial Interests, Personal, Coordinating PI: AstraZeneca; Financial Interests, Institutional, Local PI: AstraZeneca, Boehringer-Ingelheim, GSK, Roche, Seattle Genetics, Zenith Epigenetics, Gilead, Ayala Pharmaceuticals; Financial Interests, Personal, Steering Committee Member: AstraZeneca; Financial Interests, Steering Committee Member: Roche; Non-Financial Interests, Member of Board of Directors: SOLTI Breast Cancer Research; Other, Travel Grant: Pierre Fabre, Eisai, Gilead, AstraZeneca. P. Tolosa Ortega: Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, Lilly, Seagen, AstraZeneca, Daiichi Sankyo and MSD; Financial Interests, Personal, Advisory Board: Novartis, Adamed, Seagen and Daiichi Sankyo; Financial Interests, Personal, Full or part-time Employment, Medical Advisor and Medical Monitor: SOLTI; Financial Interests, Institutional, Funding: Novartis. M.J. Vidal Losada: Financial Interests, Personal, Advisory Board: Novartis/Pfizer, Roche, Pfizer, AstraZeneca/Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Novartis/Pfizer, Roche/Genentech, AstraZeneca/Daiichi Sankyo, Gilead Sciences; Financial Interests, Personal, Other, Travel, Accommodations, expenses: Pfizer; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Gilead Sciences. M. Malumbres: Financial Interests, Personal, Financially compensated role: Lilly; Financial Interests, Personal, Other: Prosenestar; Financial Interests, Personal and Institutional, Research Funding: Pfizer, Lilly, Prosenestar, PharmaMar, Circle Pharma. J. Gavilá-Gregori: Financial Interests, Personal, Advisory Board: Novartis, Pfizer, Roche. C. Saura Manich: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Bristol Meyers Squibb, Daiichi Sankyo, Eisai, Exact Sciences, Exeter Pharma, F. Hoffmann - La Roche Ltd, Gilead, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Philips, Piere Fabre, PintPharma, Puma, Roche Farma, Sanofi-Aventis, SeaGen, Zymeworks, Genentech, Innoup, Millenium, Pharmalex Spain SLU; Financial Interests, Personal, Other, SC: Byondis B.V., Glaxo, Macrogenics, Menarini, Merus, Synthon Biopharpaceuticals; Financial Interests, Institutional, Research Grant: AstraZeneca, Bayer Pharma, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Cytomx Therapeutics, Daiichi Sankyo, Eli Lilly and Company, F. Hoffmann-La RocheLtd, Genentech, GSK, Immunomedics, Innoup Farma, Macrogenics, Menarini Ricerche, Merus, Novartis, Pfizer, Puma, Roche, Sanofi-Aventis, Seattle Genetics; Financial Interests, Institutional, Coordinating PI: Byondis B.V.; Non-Financial Interests, Member: Spanish Society of Medical Oncology (SEOM), American Society for Clinical Oncology (ASCO), Geicam (Spanish Breast Cancer Research Group), European Society for Medical Oncology (ESMO), Sinology Society of the Official College of Physicians of Barcelona (COMB); Non-Financial Interests, Member, Junta Directiva y Comité Científico: SOLTI group (Academic research group in breast cancer). S. Pernas Simon: Financial Interests, Personal, Advisory Board: SeaGen, AstraZeneca- Daiichi Sankyo, Pierre-Fabre, Pfizer; Financial Interests, Personal, Invited Speaker: Lilly, Novartis, Eisai, Roche; Financial Interests, Institutional, Local PI: AstraZeneca, Novartis, Daiichi Sankyo; Non-Financial Interests, Member of Board of Directors: SOLTI. M. Margeli Vila: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Novartis, MSD, Gylead, Lilly, Pierre Fabre; Financial Interests, Personal, Other, Travel expences: Gylead; Financial Interests, Institutional, Coordinating PI, I have received research funding for my institution from Pfizer: Pfizer. 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, Member of Board of Directors, 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. E. Galve-Calvo: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Roche, Pierre Fabre, Eisai, Daiichi Sankyo, Daiichi Sankyo, AstraZeneca, AstraZeneca, Gilead, Gilead; Financial Interests, Personal, Invited Speaker: Pfizer, Daiichi Sankyo, AstraZeneca, Gilead; Other, Travel accommodation: Pfizer. A. Casas Fernandez Tejerina: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, AstraZeneca. 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, Oncolytics Biotech, Guardant Health, Peptomyc; Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo; Financial Interests, Institutional, Other, Contracted research: Boehringer Ingelheim, Medica Scientia inno. Research; Financial Interests, Personal, Advisory Board: AstraZeneca, 1TRIALSP, S.L.; Financial Interests, Personal, Member of Board of Directors, Leadership role: Reveal Genomics, SL.; Financial Interests, Personal, Stocks/Shares: Reveal Genomics, Oncolytics Biotech; Financial Interests, Personal, Royalties: Reveal Genomics, International Oncology Bureau, S.L.,; Financial Interests, Institutional, Local PI: Roche, AstraZeneca; Financial Interests, Personal and Institutional, Steering Committee Member: Daiichi Sankyo; Financial Interests, Institutional, Coordinating PI: Novartis; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation; Non-Financial Interests, Personal, Other, Asociación Española de Investigación sobre el Cáncer: ASEICA. All other authors have declared no conflicts of interest.