Prognostic factors for survival in metastatic urothelial carcinoma (mUC) have been established in patients (pts) treated with chemotherapy. However, their role has not been clearly defined in the era ...of immune-checkpoint inhibitors (ICIs). We have previously reported the Vall d’Hebron immuno-oncology prognostic index (VIO score) for refractory pts treated in phase I clinical trials with ICIs (Hierro C, et al ESMO 2018). In this retrospective study, we assessed VIO in pts with mUC treated with ICIs.
Pts with mUC enrolled from May 2015 to May 2018 in clinical trials at the Vall d’Hebron University Hospital were analysed. VIO score includes: albumin < 3.5g/dl; LDH> upper limit of normal; neutrophil/leukocytes minus neutrophils ratio (dNLR) > 3; more than 2 sites of metastasis; and presence of liver metastasis. The following VIO clusters were defined: good prognosis (0-1), intermediate prognosis (2) and poor prognosis (³3 variables). Median overall survival (OS) was calculated using Kaplan-Meier method, long rank test was used for statistical comparison. All analyses were performed using SPSS v25; IBM Inc.
Overall, 86 mUC pts received therapy with ICIs and 72 pts with complete annotation for VIO index were included in our analysis. Median age was 67.4 years, 62 (86.1%) pts were male, 66 pts (91.7%) had ECOG PS 0-1, 17 pts (23.6%) had liver metastasis and 8 pts (72%) had >2 sites of metastasis. Forty-eight pts (66.6%) were treated with ICIs as monotherapy and 24 pts (33.3%) in combination regimens. Follow-up was 13.2 moths (m) (95% CI; 10.5-15.9) and median OS was 11.3 m (95% CI; 7.1-15.4) in the evaluable population. Estimated mOS in good prognosis (62.5% of all pts), intermediate prognosis (23.6%) and poor prognosis (13.9%) were 19.3 m (95% CI; 5.1-33.6), 8.2 m (95% CI; 3.3-13.1) and 2.9 m (95% CI;0.1-7.7), respectively (p<0.001). 3-m OS rates were 95.6%, 82.4% and 50% for good, intermediate and poor prognosis, respectively (p=0.001).
VIO score is a powerful tool for predicting outcome in mUC pts treated with ICI and objectively estimating their life expectative at 3 m, which can help prioritize alternative therapies in clinical trials.
Vall d’Hebron Institute of Oncology, Vall d’ Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Has not received any funding.
R. Morales Barrera: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Asofarma; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Johnson & Johnson; Honoraria (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (institution), Travel / Accommodation / Expenses: Clovis Oncology; Honoraria (institution), Travel / Accommodation / Expenses: Lilly; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/Genentech; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals; Research grant / Funding (institution): INC; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A.; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution): Glaxosmithkline; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Millennium Pharmaceuticals; Research grant / Funding (institution): Nanobiotix SA; Research grant / Funding (institution): Novartis Farmacéutica, S.A; Research grant / Funding (institution): Pfizer, S.L.U; Research grant / Funding (institution): Puma Biotechnology; Research grant / Funding (institution): SFJ Pharma LTD; Research grant / Funding (institution): Teva Pharma S.L.U. M. Gonzalez: Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: Novartis. C. Suárez: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals; Advisory / Consultancy, Research grant / Funding (institution): Astellas Pharma; Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A.,; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb International Corporation (BMS),; Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution), Travel / Accommodation / Expenses: Hoffmann-La Roche LTD; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): GlaxoSmithKline, SA; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Lilly, S.A; Research grant / Funding (institution): Millennium Pharmaceuticals, INC; Research grant / Funding (institution): Nanobiotix SA; Research grant / Funding (institution): Novartis Farmacéutica, S.A; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Puma Biotechnology; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sanofi-Aventis, S.A; Research grant / Funding (institution): SFJ Pharma LTD. II; Research grant / Funding (institution): Teva Pharma S.L.U.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: Eusa; Advisory / Consultancy: Novartis. C. Fernandez: Travel / Accommodation / Expenses: AstraZeneca. C. Hierro: Research grant / Funding (self): Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: Ignyta. E. Serra: Travel / Accommodation / Expenses: Clovis Oncology; Travel / Accommodation / Expenses: Bayer. J. Mateo: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen; Speaker Bureau / Expert testimony: Sanofi. J. Martín Liberal: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pierre Fabre; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Ipsen. A. Quintana: Honoraria (self): Fundación Respira; Travel / Accommodation / Expenses: MSD. R. Dienstmann: Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Symphogen; Speaker Bureau / Expert testimony: Ipsen; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Servier; Research grant / Funding (self): Merck. C. Serrano: Advisory / Consultancy, Research grant / Funding (institution): Deciphera; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Blueprint; Travel / Accommodation / Expenses: PharmaMar; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Lilly. E. Garralda: Advisory / Consultancy, Research grant / Funding (institution): Roche/Genentech; Advisory / Consultancy: Ellipses Pharma; Advisory / Consultancy: Neomed Therapeutics; Advisory / Consultancy: Boeringer Ingelheim; Advisory / Consultancy: Janssen Global Services; Speaker Bureau / Expert testimony:
Activation of the mTOR pathway is associated with shorter overall survival (OS) in patients (p) with metastatic renal cell carcinoma (mRCC). This outcome could be reversed with mTOR inhibitors ...(mTORi).
We retrospectively analized by amplicon-seq mutations in mTOR, VEGF, and cell cycle pathways in 90 mRCC p who had received mTORi. A multivariate Cox model including sex, age, non-clear or sarcomatoide component, metastatic sites, IMDC subgroup, and line of mTORi was adjusted to isolate the effect of having mTORi mutations on progression-free survival (PFS), death form diagnosis (OS1) and death from mTORi treatment (OS2).
We identified 33% of p having mutations in the mTOR pathway: mTOR (17.8%), PIK3CA (5.6%), PTEN (3.3%), TSC1 (5.6%) and TSC2 (4%). No mutations were found in AKT (AKT1, AKT2, AKT3). OS for favorable, intermediate and poor prognosis of the IMDC were 43.7, 22.2 and 8.7 months respectively. As summarized in the table, in the best adjusted model there were no statistically differences in the hazard ratios (HR) of PFS, OS1 or OS2, between patient with and without mutations (M/NotM). Four long-term responders to mTORi (> 7 years) harboured mutations in one or more genes of this pathway (p53, PTEN and mTOR). Upon progression one patient adquired an LRPB1 mutation.Table975PTableAdjusted HR (Cox)PFSOS1OS 2M/NoM1.121.021.1895% CI0.67 – 1.890.61 – 1.690.63 – 2.21p0.6600.9460.607
In a multivariate adjusted model in patients with mRCC treated with mTORi, we did not find the expected worse prognosis associated with mTOR mutations. This finding can be considered as an indirect signal of the effect of mTORi on PFS and OS in patients with mTOR mutations. Although, not the most effective treatment in the overall population, some patients with specific alterations in the mTOR pathway should be considered for an mTORi.
Vall d´Hebron Institute of Oncology.
Has not received any funding.
C. Suarez Rodriguez: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): BMS; Advisory / Consultancy: Eusa; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Sanofi-Aventis; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Roche; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A; Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution):, F. Hoffmann-La Roche LTD; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Lilly, S.A; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Millennium Pharmaceuticals; Research grant / Funding (institution): Nanobiotix SA. J.A. Arranz Arija: Advisory / Consultancy, Research grant / Funding (institution): BMS; Research grant / Funding (institution): Pierre-Fabre; Research grant / Funding (institution): Novartis; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: Janssen-Cilag. R. Morales Barrera: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals, INC; Research grant / Funding (institution), Travel / Accommodation / Expenses: Astellas Pharma.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A.; Research grant / Funding (institution): Bristol-Myers Squibb International Corporation (BMS); Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis Oncology, INC,; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: F. Hoffmann-La Roche LTD/Genentech,; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Advisory / Consultancy: Johnson and Johnson; Research grant / Funding (institution): Karyopharm Therapeutics INC.,; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): Medimmune, Millennium Pharmaceuticals, INC.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: MSD; Research grant / Funding (institution): Nanobiotix SA,; Research grant / Funding (institution): Novartis Farmacéutica, S.A; Research grant / Funding (institution): Puma Biotechnology; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi-Aventis; Research grant / Funding (institution): Pharma LTD; Research grant / Funding (institution): Teva Pharma S.L.U.; Advisory / Consultancy, Speaker Bureau / Expert testimony: Asofarma. J. Puente: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (self): Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy: Merck Sharp & Dohme; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Clovis; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Eisai; Advisory / Consultancy: Eusa; Advisory / Consultancy: Sanofi-Aventis; Speaker Bureau / Expert testimony: Pierre-Fabre; Speaker Bureau / Expert testimony: Celgene; Speaker Bureau / Expert testimony: Kiowa; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Lilly. O. Reig: Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Pfizer. L. Faez: Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Pfizer. A. González del Alba: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Novartis; Advisory / Consultancy: Eusa; Advisory / Consultancy: Eisai; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: MSD. B. P. Valderrama: Honoraria (self), Advisory / Consultancy: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self): Ipsen; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Bayer; Advisory / Consultancy: Sanofi-Aventis; Advisory / Consultancy: Ipsen; Advisory / Consultancy: MSD; Travel / Accommodation / Expenses: Janssen-Cilag; Travel / Accommodation / Expenses: Pfizer. E. Gallardo: Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant /
In this study, we investigated whether outcomes with atezo (anti–PD-L1) monotherapy in mUC varied between women and men across Phase (Ph) 1-3 trials in different treatment settings.
In this post hoc ...analysis, we assessed baseline characteristics, objective response rate (ORR; RECIST 1.1) and overall survival (OS) outcomes by sex in pts with previously treated mUC (Ph 1, PCD4898g; Ph 2, IMvigor210 Cohort 2; Ph 3, IMvigor211; Ph 3b, SAUL) and cisplatin-ineligible, untreated mUC (Ph 2, IMvigor210 Cohort 1).
Across cohorts, 2459 pts were evaluated (including 464 in the IMvigor211 chemo arm); 22% were female (Table). Age was generally similar by sex, except in IMvigor210 Cohort 1 (median age: female, 77 y; male, 72 y). Median body mass index (BMI) was also similar by sex, except in PCD4898g (female, 23kg/m2; male, 28kg/m2). ECOG PS varied by sex across studies, but no consistent trend was seen. Median treatment duration was similar in females vs males, except in PCD4989g (44 d vs 108 d) and IMvigor210 Cohort 1 (123 d vs 106 d). ORR tended to be numerically higher in males (except in IMvigor210 Cohort 1; Table), although no statistically significant differences in ORR were seen except in IMvigor210 Cohort 2. Follow-up (Table) and treatment discontinuation varied by trial but were similar by sex. Median OS was similar by sex across studies; in the only randomised study, IMvigor211, no significant difference in OS benefit with atezo (vs chemo) by sex was seen (HR 95% CI: female, 0.87 0.64, 1.18; male, 0.83 0.69, 0.98; P=0.7462). Data evaluating disease and treatment characteristics by sex and outcomes accounting for potential confounders will be presented.Table927PTablePCD4989gIMvigor210IMvigor211IMvigor211SAULIMvigor210Cohort 2Atezo ArmChemo ArmCohort 1Female/male, n23/7269/241110/357103/361225/77923/96Median follow-up, mo37.832.917.317.412.629.3Investigator-assessed ORR (95% CI), %aFemale13 (3, 34)6 (2, 14)11 (6,19)8 (3, 15)12 (8, 17)26 (10, 48)Male31 (20, 43)20 (15, 26)14 (11, 18)15 (12, 19)14 (12, 17)26 (18, 36)mOS (95% CI), moFemale13.1 (4.0, 24.5)7.9 (5.0, 11.9)8.0 (5.8, 11.3)8.0 (6.3, 9.5)8.3 (6.5, 10.0)16.2 (4.4, not estimable)Male9.6 (7.3, 17.5)7.9 (6.5, 9.6)8.9 (8.0, 9.8)8.0 (7.1, 9.0)9.0 (7.6, 10.5)16.7 (10.1, 24.9)Data cutoff date31 Dec 201612 Jul 201713 Mar 201713 Mar 201716 Sep 201812 Jul 2017aFor IMvigor211, ORR-evaluable n=108/354 (atezo) and 103/358 (chemo); for SAUL, ORR-evaluable included pts with measurable and nonmeasurable disease
No significant OS differences by sex were seen across all Ph 1-3 atezo mUC studies. ORR was numerically higher in male pts with previously treated mUC, with less-pronounced differences in larger studies (e.g., IMvigor211, SAUL).
NCT01375842, NCT02951767, NCT02108652, NCT02302807, NCT02928406.
Paige Davies, PhD, of Health Interactions, funded by F. Hoffmann-La Roche, Ltd.
F. Hoffmann-La Roche, Ltd.
F. Hoffmann-La Roche, Ltd.
J. Hoffman-Censits: Full / Part-time employment: Johns Hopkins Medicine; Research grant / Funding (institution): Sibley Hospital Foundation; Honoraria (self): AstraZeneca; Honoraria (self): Foundation Medicine; Non-remunerated activity/ies, Medical Writing Services: Genentech. J.E. Rosenberg: Advisory / Consultancy, Shareholder / Stockholder / Stock options: Merck; Shareholder / Stockholder / Stock options: Illumina; Honoraria (self): UpToDate; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca/Medimmune; Honoraria (self): Medscape; Honoraria (self): Vindico; Honoraria (self): Peerview; Honoraria (self): Chugai Pharma; Advisory / Consultancy: Lilly; Advisory / Consultancy: Agensys; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche/Genentech; Advisory / Consultancy: Sanofi; Advisory / Consultancy: EMD Serono; Advisory / Consultancy, Research grant / Funding (institution): Seattle Genetics; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Licensing / Royalties: Predictor of platinum sensitivity; Advisory / Consultancy: Inovio, Bioclin, QED Therapeutics, Western Oncolytics, GSK; Advisory / Consultancy: Adicet Bio, Sensei Biotherapeutics, Fortress Biotech, Pharmacyclics; Research grant / Funding (institution): Agensys, Mirati Therapeutics, Novartis, Viralytics, Incyte. M. van Der Heijden: Honoraria (institution), Research grant / Funding (institution): Astellas; Honoraria (institution), Research grant / Funding (institution): BMS; Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Travel / Accommodation / Expenses: MSD; Honoraria (institution): Janssen. R. Dreicer: Research grant / Funding (institution): Seattle Genetics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Endocyte; Research grant / Funding (institution): BMS; Honoraria (self): Eisai; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Astellas; Honoraria (self): Janssen. J.L. Perez Gracia: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Research grant / Funding (institution): Ipsen; Advisory / Consultancy, Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Janssen. D.P. Petrylak: Advisory / Consultancy, Research grant / Funding (institution): Ada Cap; Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Shareholder / Stockholder / Stock options: Bellicum; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): Bristol Myer Squibb; Advisory / Consultancy, Research grant / Funding (institution): Clovis; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Endocyte; Advisory / Consultancy: Exelixis; Research grant / Funding (institution): Genentech; Advisory / Consultancy: Incyte; Research grant / Funding (institution): Innocrin; Advisory / Consultancy: Janssen; Research grant / Funding (institution): MedImmune; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution), Pharmacyclics- consultant; Progenics- grant (inst); Roche labs- grant (inst), consultant; Sanofi Aventis- Grant (inst); Seattle Genetics- Consultant, Grant (inst); Tyme (Stock/Investment); Urogen- Consultant: Pfizer. M.M. Retz: Full / Part-time employment: Technical University- Munich, Germany. R. Sabbatini: Full / Part-time employment: AOU Policlinico di Modena, Italy; Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BMS. E. Naglieri: Research grant / Funding (institution): Roche. C. Caserta: Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Astellas. R. Iacovelli: Advisory / Consultancy, Speaker Bureau / Expert testimony: IPSEN; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi. L. Galli: Full / Part-time employment: AOUP; Advisory / Consultancy: Janssen; Advisory / Consultancy: Pfizer. R. McDermott: Advisory / Consultancy, Personal fees: Clovis; Research grant / Funding (self), Grants and personal fees: Pfizer; Research grant / Funding (self), Grants: Amgen; Research grant / Funding (institution), Research funding and personal fees: Bristol Meyers Squibb; Research grant / Funding (self): Merck; Research grant / Funding (self): Bayer; Research grant / Funding (self): Janssen; Research grant / Funding (self): Celgene. R. Morales Barrera: Full / Part-time employment: Vall d’ Hebron Hospital; Research grant / Funding (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, Astellas, Aveo; Research grant / Funding (institution): Blueprint, BN Immunotherapeutics, BI, BMS; Research grant / Funding (institution): Cougar Biotech, Deciphera, Exelixis; Research grant / Funding (institution): GSK, Incyte, Janssen, Karyopharm Therapeutics INC., Laboratoires Leurquin Mediolanum SAS, S.A., Medimmune, Millennium Pharmaceuticals; Research grant / Funding (institution): Nanobiotix, Novartis, Pfizer, Puma Biotech, SFJ, Teva; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation
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