Abstract 1221
Background
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.
Methods
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).
Results
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, 23 kg/m2; male, 28 kg/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.Table:
927P
PCD4989g | IMvigor210 | IMvigor211 | IMvigor211 | SAUL | IMvigor210 | |
---|---|---|---|---|---|---|
Cohort 2 | Atezo Arm | Chemo Arm | Cohort 1 | |||
Female/male, n | 23/72 | 69/241 | 110/357 | 103/361 | 225/779 | 23/96 |
Median follow-up, mo | 37.8 | 32.9 | 17.3 | 17.4 | 12.6 | 29.3 |
Investigator-assessed ORR (95% CI), %a | ||||||
Female | 13 (3, 34) | 6 (2, 14) | 11 (6,19) | 8 (3, 15) | 12 (8, 17) | 26 (10, 48) |
Male | 31 (20, 43) | 20 (15, 26) | 14 (11, 18) | 15 (12, 19) | 14 (12, 17) | 26 (18, 36) |
mOS (95% CI), mo | ||||||
Female | 13.1 (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) |
Male | 9.6 (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 date | 31 Dec 2016 | 12 Jul 2017 | 13 Mar 2017 | 13 Mar 2017 | 16 Sep 2018 | 12 Jul 2017 |
For IMvigor211, ORR-evaluable n = 108/354 (atezo) and 103/358 (chemo); for SAUL, ORR-evaluable included pts with measurable and nonmeasurable disease
Conclusions
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).
Clinical trial identification
NCT01375842, NCT02951767, NCT02108652, NCT02302807, NCT02928406.
Editorial acknowledgement
Paige Davies, PhD, of Health Interactions, funded by F. Hoffmann-La Roche, Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche, Ltd.
Funding
F. Hoffmann-La Roche, Ltd.
Disclosure
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 / Expenses: Sanofi, AstraZeneca, Roche/Genentech; Honoraria (self), Speaker Bureau / Expert testimony: Asofarma; Travel / Accommodation / Expenses: Astellas, J&J, Lilly; Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis, Bayer. T. Bonfill: Full / Part-time employment: Hospital Universitari Parc Taulí; Advisory / Consultancy: Merck; Honoraria (self): BMS; Honoraria (self): Roche. S. De Ducla: Shareholder / Stockholder / Stock options, Full / Part-time employment, Spouse / Financial dependant: Roche. B. Ding: Full / Part-time employment: Roche/Genentech; Shareholder / Stockholder / Stock options: Roche. J. Linsenmeier: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. C.N. Sternberg: Full / Part-time employment: Weill Cornell Medicine; Research grant / Funding (institution): Janssen; Advisory / Consultancy: Merck; Advisory / Consultancy: Clovis; Advisory / Consultancy: BMS; Advisory / Consultancy: Incyte; Advisory / Consultancy: AstraZeneca; Honoraria (self): Lilly. All other authors have declared no conflicts of interest.
Resources from the same session
5105 - Fresh blood Immune cell monitoring in patients treated with nivolumab in the GETUG-AFU26 NIVOREN study: association with toxicity and treatment outcome
Presenter: Aude DESNOYER
Session: Poster Display session 3
Resources:
Abstract
1877 - Advanced clear-cell renal cell carcinoma (accRCC): association of microRNAs (miRNAs) with molecular subtypes, mRNA targets and outcome.
Presenter: Annelies Verbiest
Session: Poster Display session 3
Resources:
Abstract
5543 - Prior tyrosine kinase inhibitors (TKI) and antibiotics (ATB) use are associated with distinct gut microbiota ‘guilds’ in renal cell carcinoma (RCC) patients
Presenter: Valerio Iebba
Session: Poster Display session 3
Resources:
Abstract
2689 - mTOR mutations are not associated with shorter PFS and OS in patients treated with mTOR inhibitors
Presenter: Cristina Suarez Rodriguez
Session: Poster Display session 3
Resources:
Abstract
3069 - Efficacy of immune checkpoint inhibitors (ICI) and genomic alterations by body mass index (BMI) in Advanced Renal Cell Carcinoma (RCC)
Presenter: Aly-Khan Lalani
Session: Poster Display session 3
Resources:
Abstract
5089 - Finding the Right Biomarker for Renal Cell Carcinoma (RCC): Nivolumab treatment induces the expression of specific peripheral lymphocyte microRNAs in patients with durable and complete response.
Presenter: Lorena Incorvaia
Session: Poster Display session 3
Resources:
Abstract
2594 - Algorithms derived from quantitative pathology can be a gatekeeper in patient selection for clinical trials in localised clear cell renal cell carcinoma (ccRCC)
Presenter: In Hwa Um
Session: Poster Display session 3
Resources:
Abstract
2566 - High baseline blood volume is an independent favorable prognostic factor for overall and progression-free survival in patients with metastatic renal cell carcinoma
Presenter: Aska Drljevic-nielsen
Session: Poster Display session 3
Resources:
Abstract
2675 - Impact of estimand selection on adjuvant treatment outcomes in renal cell carcinoma (RCC)
Presenter: Daniel George
Session: Poster Display session 3
Resources:
Abstract
1541 - TERT gene fusions characterize a subset of metastatic Leydig cell tumors
Presenter: Bozo Kruslin
Session: Poster Display session 3
Resources:
Abstract