1221 - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)

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

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.