Abstract 748P
Background
SAUL, a phase IIIb study reported real-world data on atezolizumab used for mUC relapsing after 1st-line therapy (Sternberg et al, Eur Urol 2019). Hb<10 g/dL, liver mets, ECOG> 0 and time from last chemotherapy (TFLC) are associated with worse outcomes in 2nd-line chemotherapy but their significance in the immunotherapy setting is unknown. We studied the association of the above factors, previous use of cis- or carbo-platin and PD-L1 expression with outcomes using the SAUL database.
Methods
We excluded patients who did not receive cis or carbo. Patients who received both were categorized as cis-treated. The major outcome measure was overall survival (OS).
Results
969 pts were included. Selected baseline characteristics and subgroup efficacy outcomes are shown in the table. 551 pts (56.9%) had ECOG PS>0, 265 (27.3%) liver mets, 152 (15.7%) Hb< 10. Median OS (mOS) and median progression-free survival for the whole population were 8.6 (7.6-9.7) and 2.2 (2.1-2.4) mos. The prognostic significance of ECOG PS, anaemia, liver mets and Bellmunt risk score was confirmed. The number of previous lines of therapy was not associated with outcomes. There was a strong correlation of mOS with TFLC: 6.7 mos (5.4-7.8) for <3 vs. 14.2 (10-NR) for >9 mos and PD-L1 expression: 7.8 (6.5-9) for IC 0/1 vs.11.6 (8.8-18.8) mos for IC2/3. No interaction of PD-L1 expression with other prognostic factors was observed. There was a trend for better outcome after previous cisplatin vs. carboplatin (p=0.056). Nevertheless, further analyses, stratified for other significant factors did not confirm a significant association of previous therapy with OS. Table: 748P
| n | Median OS (95% CI) | Median PFS (95% CI) | ORR (%) | |
| Bellmunt Risk factors 0 1 2-3 | 296 383 265 | 17.9 (12.7-NR) 8.9 (7.5-10.9) 3.3 (2.7-4) | 4.1 (3.5-4.4) 2.3 (2.1-2.8) 2 (1.9-2.1) | 18.6 13.8 6.8 |
| Previous therapy Cis-based Carbo-based | 581 388 | 9.4 (8.1-10.9) 7.5 (6.4-9.2) | 2.3 (2.1-2.5) 2.2 (2.1-2.4) | 14.8 11.1 |
| Previous Lines 0 1 2-3 | 369 531 69 | 9.7 (7.5-11.9) 8.3 (7.2-9.7) 7.4 (4.5-NR) | 2.2 (2.1-2.9) 2.2 (2.1-2.4) 2.1 (2-2.6) | 15.7 11.5 14.5 |
| PD-L1 expression 0-1 2-3 | 647 257 | 7.8 (6.5-9) 11.6 (8.8-18.8) | 2.1 (2.1-2.3) 2.6 (2.1-4.1) | 10.2 20.6 |
| Time from last Chemo in months 0-3 3-6 6-9 >9 | 353 240 172 204 | 6.7 (5.4-7.8) 7.5 (5.7-9.9) 10.6 (8.4-18) 14.2 (10-NR) | 2.1 (2.1-2.2) 2.1 (2.1-2.3) 2.5 (2.2-4.1) 4 (3.1-4.9) | 8.2 11.7 19.2 19.1 |
Conclusions
Post-platinum atezolizumab is active in mUC, irrespective of previous lines of therapy or previous platinum compound. In addition, to the established Bellmunt risk stratification, PD-L1 expression and TFLC were strongly correlated with OS, indicating the need for novel prognostic algorithms for immunotherapy-treated patients with mUC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Aristotelis Bamias.
Funding
Hellenic GU Cancer Group.
Disclosure
A. Bamias: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Honoraria (self): Debiopharm; Advisory/Consultancy, Research grant/Funding (self): Pfizer. A. Merseburger: Honoraria (self): AstraZeneca, Bristol-Myers Squibb, Eisai, Ipsen, MSD, Merck Serono, Janssen, Takeda, TEVA, Astellas, Novartis, Pfizer, Roche.; Advisory/Consultancy: AstraZeneca, Astellas, Bristol-Myers Squibb, Ipsen, Janssen, EUSAPharm, MSD, Merck Serono, Novartis, Takeda, Teva, Pfizer und Roche; Research grant/Funding (self): AstraZeneca, Astellas, Bristol-Myers Squibb, Ipsen, Janssen, EUSAPharm, MSD, Merck Serono, Novartis, Takeda, Teva, Pfizer und Roche. Y. Loriot: Honoraria (self), Advisory/Consultancy: Roche, Astellas, Janssen, Seattle Genetics, AstraZeneca, MSD, Pfizer, Ipsen, Sanofi; Research grant/Funding (self), Research grant/Funding (institution): Roche, Astellas, Janssen, Seattle Genetics, AstraZeneca, MSD, Pfizer, Ipsen, Sanofi, BMS, Clovis, Incyte. N. James: Honoraria (self): Roche; Advisory/Consultancy: Roche, AstraZeneca, Merck. D. Castellano Gauna: Honoraria (self), Research grant/Funding (institution): Janssen Oncology; Honoraria (self), Travel/Accommodation/Expenses: Roche/Genentech; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Ipsen, MSD, Lilly, BMS, Novartis, Pierre Fabre, Sanofi. F. Lopez-Rios: Honoraria (self): AbbVie, Bayer, Roche, AstraZeneca, BMS, MSD, Pfizer, Thermo Fisher, Lilly. M.W. Kramer: Honoraria (self): BMS, Roche, Merck, Janssen, Bayer, Novartis, Eusai, Pfizer; Travel/Accommodation/Expenses: Ipsen, Pierre Fabre. G. de Velasco: Honoraria (self), Research grant/Funding (self): Pfizer, Novartis, Roche, MSD, Astellas, Bayer, Ipsen, Janssen, Merck. C.N. Sternberg: Advisory/Consultancy: Pfizer, MSD, Merck, AstraZeneca, Astellas, Sanofi-Genzyme, Roche-Genentech, Incyte, Medscape, UroToday. All other authors have declared no conflicts of interest.