263P - Efficacy and safety of neoadjuvant chemotherapy combination with pembrolizumab in triple-negative breast cancer: Real-world data

Background

Neoadjuvant chemotherapy (NAC) with the addition of Pembrolizumab (anti-PD1) is the current standard of care for early-stage II-III triple-negative breast cancer (TNBC). Although immunotherapy improves efficacy, toxicity rates remain a paramount parameter to consider since many of the events are long-lasting for this subset of patients (pts) treated with a curative intent.

Methods

We conducted a retrospective analysis of the medical records of 95 pts with early-stage TNBC treated with NAC and Pembrolizumab, between April 2022 and April 2023 in our institution. At the time of this submission, the toxicity analysis is available for 74 pts and efficacy for 64 pts. A complete analysis of 95 pts will be presented at ESMO. Treatment-related toxicities are reported according to the common terminology criteria for adverse events (CTCAE) v5.0.

Results

The cohort currently comprises 74 female patients, with a median age of 50 years [20-74]; 52% were premenopausal, and 20% harboured a deleterious BRCA germline mutation. Efficacy analysis (n=64): Pathologic complete response (pCR) rate was 56 % (n=36). The rate of pCR in pts with BRCA1/2 germline mutations was 80% (n=12). Toxicity analysis (n=74): We reported 376 toxicity events, of which 27% were grade 3-4. Most events were attributed to chemotherapy (55%). The immune-related adverse events (irAE) rate was 26%. A total of 35% of pts discontinued treatment due to toxicity, most commonly: liver toxicity, recurrent severe haematological and severe skin toxicities; while 50% of pts required dose reductions. The most common grade 3-4 AEs were neutropenia in 49% of pts and hepatic toxicity in 30% of cases. Immune-mediated thyroid dysfunction occurred in 25.7%, adrenal insufficiency was witnessed in 5%(4) of pts and hypophysitis in 4%(3). Immune-mediated myocarditis was witnessed in 1 elderly patient.

Conclusions

In this real-life cohort of early-stage TNBC patients treatment with a chemo-immunotherapy combination in the neoadjuvant setting was effective. However, we witnessed an important rate of treatment discontinuation due to toxicity. The impact on the quality of life of these patients should be carefully evaluated, especially in regard to permanent toxicities.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

C. Baldini: Financial Interests, Personal, Advisory Role: Bicycle therapeutics, Rising Tide Fundation, ITEOS; Financial Interests, Institutional, Principal Investigator: Abbvie, Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, AstraZeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beige; Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, Boehringer Ingelheim, GSK, INCA, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi; Non-Financial Interests, Institutional, Product Samples: AstraZeneca, Bayer, BMS, Boringher Ingelheim, GSK, MedImmune, Merck, NH TherAGuiX, Pfizer, Roche. S. Champiat: Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Genmab, Janssen, Merck, Merck Serono, Novartis and Roche; Financial Interests, Personal, Other, Principal Investigator of Clinical Trials: AbbVie, Amgen, Boehringer Ingelheim, Cytovation, Eisai, Imcheck Therapeutics, Molecular Partners Ag, Merck, Ose Pharma, Pierre Fabre, Sanofi Aventis, Sotio A.S, Transgene; Financial Interests, Personal, Advisory Board: Alderaan Biotechnology, Amgen, AstraZeneca, Avacta, Celanese, Domain Therapeutics, Ellipses Pharma, Genmab, Immunicom, Inc., Nanobiotix, Nextcure, Oncovita, Pierre Fabre, Seagen, Tatum Bioscience, Tollys SAS, UltraHuman8; Financial Interests, Personal, Other, Travel and congress: Amgen, AstraZeneca, Bristol Myers Squibb, Merck, Ose Pharma, Roche, Sotio; Financial Interests, Institutional, Other, As part of the Drug Development Department (DITEP) =Principal/sub-Investigator of Clinical Trials: Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Adaptimmune, AdlaiAstex Pharmaceuticals, AstraZeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, BicycleTx Ltd, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Casi Pharmaceuticals, Inc, Celgene Corporation, Cellcentric, Chugai Pharmaceutical Co, Cullinan-Apollo, Curevac, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Faron Pharmaceuticals Ltd, Forma Tharapeutics, Gamamabs, Genentech, GSK, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Incyte Corporation, Imcheck Therapeutics, Incyte Corporation, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Iteos Belgium SA, Janssen Cilag, Janssen Research Foundation, Janssen R&D LLC, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, MedImmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Genomics, Ose Pharma, Pfizer, PharmaMar, Pierre Fabre Medicament, Relay Therapeutics, Inc, Roche, Sanofi Aventis, Seattle Genetics, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Transgene S.A, Turning Point Therapeutics, Xencor; Financial Interests, Institutional, Research Grant, As part of the Drug Development Department (DITEP) =Research Grants: AstraZeneca, BMS, Boehringer Ingelheim, GSK, INCA, Janssen Cilag, Merck, Pfizer, Roche, Sanofi; Non-Financial Interests, Institutional, Product Samples, As part of the Drug Development Department (DITEP) =Non-financial support (drug supplied): AstraZeneca, BMS, Boehringer Ingelheim, GSK, MedImmune, Merck, NH TherAGuiX, Pfizer, Roche. B. Pistilli: Financial Interests, Institutional, Advisory Board: AstraZeneca, Seagen, Lilly, Daiichi Sankyo, MSD; Financial Interests, Institutional, Invited Speaker: Gilead, Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre, Daiichi Sankyo; Financial Interests, Personal, Other, travel support: AstraZeneca, Pierre Fabre, MSD, Daiichi Sankyo; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Novartis; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Local PI: AstraZeneca, Gilead, Seagen, MSD, Novartis; Financial Interests, Institutional, Funding: Daiichi Sankyo; Non-Financial Interests, Project Lead: UNICANCER. J.T.M.L. Ribeiro: Financial Interests, Personal, Advisory Board: Gilead Sciences, Inc.; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: eESO. All other authors have declared no conflicts of interest.