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METHOD FOR IDENTIFYING LUNG CANCER PATIENTS FOR A COMBINATION TREATMENT OF IMMUNO- AND CHEMOTHERAPYCM Patents

Índice de la ficha

Updated at
24/07/2026
Numero publicacion
EP.4310197.A1
Fecha publicacion
24/01/2024
Numero solicitud
EP20220382701
Fecha presentacion
21/07/2022

En detalle

Resumen

The present invention relates to the field of in vitro methods for identifying a subject suitable for treatment with a combination of immunotherapy and chemotherapy by identifying a specific genetic signature in a biological sample from said subject as well as diagnostic devices for performing said method.

Reivindicaciones

1. An in vitro method for identifying a subject suitable for treatment with a combination of immunotherapy and chemotherapy, comprising determining the absence of a somatic mutation in at least two of the genes EGFR, KMT2C, APC, ERBB3, and HNF1A, and/or the absence of a germline mutation in PBRM1 in a biological sample from the subject, wherein the subject is afflicted with cancer. 2. The method of claim 1, wherein the absence of a somatic mutation in at least two of the genes EGFR, KMT2C, APC, ERBB3, and HNF1A, and/or the absence of a germline mutation in PBRM1 in a biological sample from the subject indicates that said subject is more likely to respond to a treatment with a combination of immunotherapy and chemotherapy than a subject not having said absence. 3. The method of any one of the preceding claims, comprising determining the absence of a somatic mutation in at least three, at least four, or in all of the genes EGFR, KMT2C, APC, ERBB3, and HNF1A, and/or the absence of a germline mutation in PBRM1. 4. The method of any one of the preceding claims, wherein the germline mutation in PBRM1 is variant c.1443+60T>G. 5. The method of any one of the preceding claims, wherein the cancer comprises lung cancer, preferably non-small cell lung cancer (NSCLC). 6. The method of any one of the preceding claims, wherein the immunotherapy comprises a therapy using PD-1 or PD-L1 antagonists, preferably wherein said PD-1 or PD-L1 antagonists are selected from Pembrolizumab, Nivolumab and/or Atezolizumab, Ipilimumab, Durvalumab. 7. The method of any one of the preceding claims, wherein the chemotherapy comprises the use of a chemotherapeutic agent selected from paclitaxel, carboplatin, docetaxel, oxaliplatin, cisplatin, or any combination thereof. 8. The method of any one of the preceding claims, wherein the biological sample comprises a tumor tissue biopsy, a liquid biopsy, blood, serum, plasma, genomic DNA, circulating tumor cells, ctDNA, cfDNA, or any combination thereof. 9. A diagnostic device/kit for determining the absence of a somatic mutation in at least one of the genes EGFR, KMT2C, APC, ERBB3 and HNF1A, and/or the absence of a germline mutation in PBRM1 in a biological sample from a subject afflicted with cancer. 10. The diagnostic device of claim 9, wherein the absence of a somatic mutation in at least two of the genes EGFR, KMT2C, APC, ERBB3 and HNF1A, and/or the absence of a germline mutation in PBRM1 in a biological sample from the subject indicates that said subject is more likely to respond to a combination of immunotherapy and chemotherapy than a subject not having said absence. 11. The diagnostic device of any one of claims 9 or 10, wherein the cancer is lung cancer, preferably non-small cell lung cancer (NSCLC). 12. The diagnostic device of any one of claims 9 to 11, wherein the immunotherapy comprises a therapy using PD-1 or PD-L1 antagonists, preferably selected from Pembrolizumab, Nivolumab and/or Atezolizumab, Ipilimumab, Durvalumab. 13. The diagnostic device of any one of claims 9 to 12, wherein the biological sample comprises a tumor tissue biopsy, a liquid biopsy, blood, serum, plasma, circulating tumor cells, ctDNA, cfDNA, or any combination thereof. 14. The diagnostic device of any one of claims 9 to 13, wherein the germline mutation in PBRM1 is variant c.1443+60T>G. 15. In vitro use of the absence of a somatic mutation in at least two of the genes EGFR, KMT2C, APC, ERBB3 and HNF1A, or the absence of a germline mutation in PBRM1, preferably the germline mutation c.1443+60T>G in PBRM1, as biomarkers in determining whether an anticancer effect is likely to be produced in a cancer by a combination of immunotherapy and chemotherapy, in particular immunotherapy with PD-1 or PD-L1 antagonists.

Etiquetas

Inventores
Romero Alfonso AtochaSerna Blasco RobertoProvencio Pulla Mariano
Solicitantes
Fundacion Para la Investigacion Biomedica del Hospital Univ Puerta de Hierro MajadahondaFundación Para la Investigación Biomédica del Hospital Universitario Puerta de Hierro MajadahondaUniversidad Autónoma de MadridFund Gecp
Clasificacion ipc
C12Q 1/ 6886 A I
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