EGAGenomicsCancer Genomicshttps://ega-archive.org/studies/EGAS00001004074EGAEGA study EGAS00001004074NanoString raw dataMDA whole exome sequencing data for bladder cancerrestrictedEGAPilot, CP-675206, Safeties, other disease, Ctla-4, localised, Platinol, cis-Diamminedichloroplatinum(II), cis-Dichlorodiammineplatinum(II), single-organism developmental process, Laboratory, Randa, neoplasia, transitional cell carcinoma of the urinary tract, PILOT, (SP-4-2)-, congenital defects, aplasia, Publication., Relative, diseases, PDCD1L1, MEDI4736, responsivity, Peyrone's chloride, ALPS5, disease or disorder, diseases and disorders, colon inflammation, defects, Hepatitides, preoperative procedures, B7-H1, neoplasm, Peyrone's salt, treatment, CD274, study, reactivity, CD152, Programmed death ligand 1, proportion, MEDI-4736, human disease, cis-Diamminedichloroplatinum, cell process disease, tumor disease, cis-diamminedichloridoplatinum(II), cis-DDP, neoplasm (disease), cis-Platinum, hypoplasia, CP675 cpd, PD-L1, Lederplatin, ticilimumab, Briplatin, Platamine, non-neoplastic, CD, Clients, Cisplatin, Liver inflammation, disease management, (SP-4-2)-diamminedichloroplatinum, disorder, urothelial carcinoma, Homo sapiens disease, IDDM12, operative procedures, tumor, CP675206, Colitides, ICT, EGR-3, PDL1, ratio, colitis, data, Cytotoxic T-lymphocyte-associated antigen 4, Cismaplat, NSC-119875, disorders, inflammation of colon, intraoperative procedures, neoplastic disease, medical condition, CTLA4, cis Platinum, transitional cell car. -uroth., Client, diamminedichloro-, deformities, cytotoxic T-lymphocyte-associated antigen 4, development, colitis (disease), neoplastic growth, Ly-56, peroperative procedures, PDCD1LG1, CP 675, agenesis, (SP-4-2)-diamminedichloridoplatinum, B7-H, Relative Risks, Diseases, CDDP, condition, PDCD1 ligand 1, Cd152, focal, laboratory, 206, GRD4, cis-diammineplatinum(II) dichloride, Relative Risk, PCR, cis-diamminedichloroplatinum, B7H1, atresia, cis-platin, B7 homolog 1, Imfinzi, CELIAC3, cis-[PtCl2(NH3)2], cis-diamminedichloroplatinum(II), cis-dichlorodiammineplatinum(II), Risk, pT1, operative therapy, Neoplatin, Diamminodichloride, Risks, Dichlorodiammineplatinum, proportionality, malformations, cis Diamminedichloroplatinum, [PtCl2(NH3)2], transitional cell carcinoma of the urothelial tract, Platinum Diamminodichloride, operations, Platinum, cisplatine, rate, GSE, CTLA-4, disease of cellular proliferation, cisplatin, cisplatino, Uroepithelial carcinoma, disease, CP 675206, CP-675, Patient, Platidiam, birth defects, anomalies, Biocisplatinum, Platino, quotient, perioperative procedures, cisplatinum, response, other neoplasm, Platinex, invasive proceduresCtla-4, Cytotoxic T-lymphocyte-associated antigen 4, Platinol, cis-Diamminedichloroplatinum(II), cis-Dichlorodiammineplatinum(II), Cismaplat, Randa, NSC-119875, transitional cell carcinoma of the urinary tract., (SP-4-2)-, CTLA4, cis Platinum, transitional cell car. -uroth., Client, diamminedichloro-, cytotoxic T-lymphocyte-associated antigen 4, Ly-56, PDCD1LG1, PDCD1L1, B7-H, (SP-4-2)-diamminedichloridoplatinum, ALPS5, Peyrone's chloride, CDDP, PDCD1 ligand 1, Cd152, B7-H1, GRD4, Peyrone's salt, cis-diammineplatinum(II) dichloride, cis-diamminedichloroplatinum, B7H1, CD274, B7 homolog 1, CD152, cis-platin, Programmed death ligand 1, CELIAC3, cis-[PtCl2(NH3)2], cis-diamminedichloroplatinum(II), cis-Diamminedichloroplatinum, cis-dichlorodiammineplatinum(II), Neoplatin, cis-diamminedichloridoplatinum(II), cis-DDP, Diamminodichloride, Dichlorodiammineplatinum, cis-Platinum, cis Diamminedichloroplatinum, [PtCl2(NH3)2], Platinum Diamminodichloride, transitional cell carcinoma of the urothelial tract, Platinum, cisplatine, PD-L1, GSE, Lederplatin, CTLA-4, Briplatin, cisplatin, Platamine, cisplatino, CD, Uroepithelial carcinoma, Patient, Clients, Platidiam, Biocisplatinum, Cisplatin, Platino, (SP-4-2)-diamminedichloroplatinum, urothelial carcinoma, cisplatinum, IDDM12, PDL1, Platinex0.00.00.00.00.0falseNeoadjuvant combination PD-L1 plus CTLA-4 blockade in patients with cisplatin-ineligible operable urothelial carcinomaImmune checkpoint therapy (ICT) is being tested in the neoadjuvant setting for patients with localized urothelial carcinoma (UC), with one study reporting data in cisplatin-ineligible patients who received anti PD-L1 monotherapy. The study reported that patients with bulky tumors, a known high-risk feature defined as greater than clinical T2 disease, had fewer responses, with pathologic complete response (pCR) rate of 17%. Here, we report on the first pilot combination neoadjuvant trial (NCT02812420) with anti-PD-L1 (durvalumab) plus anti-CTLA-4 (tremelimumab) in cisplatin-ineligible patients, with all tumors identified as having high risk features (N=28). Primary endpoint was safety and we observed 6 of 28 patients (21%) with
grade ≥3 immune-related adverse events, consisting of asymptomatic laboratory abnormalities (N=4), hepatitis and colitis (N=2). We also observed pCR of 37.5% and downstaging to pT1 or less in 58% of patients who completed surgery (N=24). In summary, we provide initial safety, efficacy and biomarker data with neoadjuvant combination anti-PD-L1 plus anti-CTLA-4, which warrants further development for patients with localized UC, especially cisplatin-ineligible patients with high-risk features who do not currently have an established standard-of-care neoadjuvant treatment.
Publication:2021-01-28 12:30:40EGAS000010040749606EGAD00010001852EGAC00001001412EGAD00001005712