80P - Tumor markers evolution in pts treated with TCE and association with radiologic response

Background

Immunotherapy has revolutionized cancer treatment. Recently, new agents that redirect T-cells to target cancer have become increasingly evaluated across different types of tumors. One of the endpoints of clinical studies involving T-cell engagers (TCE) is looking at the tumor markers in the serum as a surrogate biomarker for response. However, no studies have shown the correlation between tumor biomarkers and response with these new drugs.

Methods

We retrospectively analyzed the medical records of patients (pts) treated with a TCE in phase 1 study at Gustave Roussy for solid tumors between June 2016 and January 2024. These patients had informative tumor markers at baseline. Type of cancers, first radiological response, number of prior lines of therapy, progression free survival (PFS), overall survival (OS) were assessed, as well as tumor markers at baseline, at 1^st evaluation and in-between when available.

Results

Out of the 147 pts treated with TCE, 67 had an informative tumor marker (CEA, CA125, PSA), including 51.5% had prostate cancer, 20.3% ovarian carcinoma, 22.1% colorectal cancer, 2.9% breast cancer and 2.9% pancreatic cancer. Median (md) prior lines was 4; md PFS 2.2 months (m), md OS 7.3 m. Overall response rate was 3% (2/67 pts). Pts had a median age of 62 years old at baseline. 68 had tumor marker dosed at baseline, 63 at an intermediate timepoint and 67 at the first radiologic reevaluation. Out of 27 pts who had a decrease in tumor markers, 7.4% (2) presented a partial response, 59.3% (16) remained stable and 33.3% (9) had progressive disease. Among the 38 pts with increased tumor markers, 71% (27) showed progression, 29% (11) remained stable and no patient presented a partial response. The 2 patients with stable tumor markers showed radiological progression.

Conclusions

In our retrospective analysis, preliminary results showed that evolution of serum tumor markers didn’t seemed to be a good surrogate for the radiological response in patients receiving T-cell engager therapy. The cohort will be extended prospectively to other centers to implement additional patients and data and further analyses including intermediate time points and spaghetti plots figures will be presented at the congress.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

K. Ouali: Financial Interests, Institutional, Other, As part of the Drug Development Department (DITEP), KO is principal/sub-Investigator of Clinical Trials for AbbVie, Adaptimmune, Adlai Nortye USA Inc., Aduro Biotech, Agios Pharmaceuticals, Amgen, AstraZeneca Ab, AstraZeneca, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Beigene, BicycleTx Ltd, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Casi Pharmaceuticals, Inc., Cato Research, Celgene Corporation, Cellcentric, Chugai Pharmaceutical Co, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, EverImmune, Exelixis, Faron Pharmaceuticals Ltd, Foghorn Therapeutics Inc., Forma Therapeutics, Gamamabs, Genentech, Genmab, GSK, H3 Biomedicine, Hoffmann La Roche Ag, IGM Biosciences, Imcheck Therapeutics, Incyte Corporation, Innate Pharma, Iris Servier, Iteos Belgium SA, Janssen Cilag, Janssen Research Foundation, Janssen R&D LLC, K-Group Beta, Kinnate Biopharma, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France,: Various drug companies. N. Herbel: Financial Interests, Personal, Full or part-time Employment: Viroxis Biotech. S. Champiat: Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Genmab, Janssen, Merck KGaA, MSD, Novartis, Roche, Servier, Takeda; Financial Interests, Personal, Other, Principal Investigator of Clinical Trials: AbbVie, Amgen, Boehringer Ingelheim, Bolt Biotherapeutics, Centessa Pharmaceuticals, Cytovation, Eisai, GSK, Imcheck Therapeutics, Immunocore, Molecular Partners Ag, MSD, Ose Immunotherapeutics, Pierre Fabre, Replimune, Roche, Sanofi Aventis, Seagen, Sotio A.S, Transgene; Financial Interests, Personal, Advisory Board: Access Trial, Alderaan Biotechnology, Amgen, AstraZeneca, Avacta, Beigene, BioNTech, Celanese, Domain Therapeutics, Ellipses Pharma, Genmab, Harpoon Therapeutics, Immunicom, Inc., Mariana Oncology, Mima Health, Nanobiotix, Nextcure, Oncovita, Pierre Fabre, Seagen, Takeda, Tatum Bioscience, Tollys, UltraHuman8; Financial Interests, Personal, Other, Travel and congress: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Ose Immunotherapeutics, Roche; 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 Therapeutics, Gamamabs, Genentech, GlaxoSmithKline, 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, Personal, Other, Travel and Congress: Sotio; Financial Interests, Personal, Stocks/Shares: Avacta; 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. A. Hollebecque: Financial Interests, Personal, Invited Speaker: Servier, Incyte, EISAI, BMS; Financial Interests, Personal, Advisory Board: Basilea, Taiho, Relay Therapeutics, QED Therapeutics, Debiopharm, MSD, Boehringer Ingelheim; Financial Interests, Institutional, Funding: Incyte; Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Personal, Principal Investigator, M19-345 ; M21-404: AbbVie; Non-Financial Interests, Personal, Principal Investigator, CO42216; WP42627; CO40939; GO44479; GO42216: Roche; Non-Financial Interests, Personal, Principal Investigator, MCLA-158; MCLA-128: Merus; Non-Financial Interests, Personal, Principal Investigator, SGNB6A: Seattle Genetics; Non-Financial Interests, Personal, Principal Investigator, TAS-120-202: Taiho; Non-Financial Interests, Personal, Principal Investigator, Krystal-10: Mirati; Non-Financial Interests, Personal, Principal Investigator, ADP-0033: Adaptimmune; Non-Financial Interests, Personal, Principal Investigator, ACT16902: Sanofi; Non-Financial Interests, Personal, Principal Investigator, C4201002; SGNB6A: Pfizer; Non-Financial Interests, Personal, Principal Investigator, RLY-4008: Relay Therapeutics; Non-Financial Interests, Personal, Principal Investigator, CC-90011: Celgene/BMS; Non-Financial Interests, Personal, Principal Investigator, Loxo-IDH; Loxo-RAS: Loxo/Lilly; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca; Non-Financial Interests, Personal, Principal Investigator, SN-201 study: Sotio; Non-Financial Interests, Personal, Principal Investigator, Tropics-03: Gilead; Non-Financial Interests, Personal, Principal Investigator, BI1403: Boehringer Ingelheim; Non-Financial Interests, Personal, Principal Investigator, CA120-1001: BMS. C. Smolenschi: Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Institutional, Other, Pi: BMS; Financial Interests, Personal, Other, Funding: Merck. A. Patrikidou: Financial Interests, Personal, Advisory Board, advisory board urothelial cancer: Basilea; Financial Interests, Personal, Other, Congress subscription: Amgen; Financial Interests, Personal, Other, congress expenses: Bristol Myers Squibb, MSD, Roche; Financial Interests, Institutional, Local PI, Not paid yet, pending: AstraZeneca; Other, Personal, Other, congress expenses: Janssen. J. Michot: Financial Interests, Personal, Other, Steering committee: Regeneron; Financial Interests, Personal, Advisory Board: Gilead, Ideogen. Y. Loriot: Financial Interests, Personal, Advisory Board: Merck KGaA, Pfizer, Gilead, Seattle Genetics, Tahio; Financial Interests, Personal, Other, Lectures, Advisory Boards: MSD, AstraZeneca, Astellas, Janssen; Financial Interests, Personal, Other, Lectures, Advisory Boards: Roche, BMS; Financial Interests, Institutional, Research Grant: Janssen, Sanofi, MSD, Roche, Celsius; Financial Interests, Institutional, Steering Committee Member: Janssen; Financial Interests, Personal, Steering Committee Member: ,MSD, Astellas, Gilead/Immunomedics, Basilea, Tahio; Financial Interests, Institutional, Local PI: Pfizer, MSD, Janssen, Exelexis, AstraZeneca, Pfizer, Merck KGaA, BMS, Astellas, Gilead, INCYTE; Financial Interests, Institutional, Coordinating PI: Janssen; Non-Financial Interests, Personal, Member: ESMO, ASCO, AACR; Non-Financial Interests, Personal, Other, scientific committee: ARC. C.P. Massard: Other, Personal, Other, Christophe Massard: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer Ipsen, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, Netcancer, Pegascy Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro, Agios, Amgen, Argen-x, Astex, AstraZeneca, Aveo Pharmaceuticals, Bayer, Beigene, Blueprint, BMS, Boehringer Ingelheim, Celgene, Chugai, Clovis, Daiichi Sankyo, Debiopharm, Eisai, Eos, Exelixis, Forma, Gamamabs, Genentech, Gortec, GSK, H3 Biomedicine, Incyte, Innate Pharma, Janssen, Kura Oncology, Kyowa, Lilly, Loxo, Lysarc, Lytix Biopharma, MedImmune, Menarini, Merus, MSD, Nanobiotix, Nektar Therapeutics, Novartis, Octimet, Oncoethix, Oncopeptides AB, Orion, Pfizer, PharmaMar, Pierre Fabre, Roche, Sanofi, Servier, Sierra Oncology, Taiho, Takeda, Tesaro, Xencor: Company. A. Bernard-Tessier: Financial Interests, Personal, Invited Speaker: Astellas, Bayer, AstraZeneca; Financial Interests, Personal, Other, travel fees: ORION; Financial Interests, Institutional, Advisory Board: Novartis, Roche, Janssen, MSD, AAA-Novartis; Financial Interests, Personal, Writing Engagement: Bouchara-Recordati; Non-Financial Interests, Personal, Principal Investigator: Amgen, Macrogenics, Janssen. C. Baldini: Financial Interests, Institutional, Advisory Board: BMS, MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Coordinating PI: iTeos, Janssen, Seattle Genetics, Tahio, Pyramid Bioscience; Financial Interests, Institutional, Local PI: AZ, Amgen, Bicycle Therapeutics, MSD, Tango, Roche Genentech; Non-Financial Interests, Personal, Member: ASCO, SIOG, SOFOG, AACR, ESMO. All other authors have declared no conflicts of interest.