Abstract 699P
Background
Cisplatin-based chemotherapy is the standard of care for first-line (1L) metastatic urothelial carcinoma (mUC), although many patients (pts) are ineligible for treatment with cisplatin. Cohort 1 of the single-arm phase II IMvigor210 study evaluated the efficacy and safety of 1L atezolizumab (atezo, anti–PD-L1) in cisplatin-ineligible pts with mUC (Balar Lancet 2017) and demonstrated sustained responses with longer follow-up (Loriot ASCO 2019). The ongoing randomised phase III IMvigor130 study is following on these observations (Galsky Lancet 2020; Davis AACR 2021 abst 5130). Here, we report data based on over 5 years of follow-up from IMvigor210 Cohort 1.
Methods
Cisplatin-ineligible pts with untreated mUC received atezolizumab monotherapy 1200 mg IV q3w until disease progression by RECIST 1.1 or toxicity. The primary endpoint was confirmed objective response rate (ORR; RECIST 1.1) per independent review facility (IRF). Secondary endpoints included duration of response (DOR) and overall survival (OS). In this analysis, efficacy by PD-L1 status on tumour-infiltrating immune cells (VENTANA SP142 IHC assay) was descriptively evaluated.
Results
119 patients were efficacy evaluable. As of data cutoff 31 January 2021, minimum follow-up was 5.8 years. Median DOR was 59.1 mo (≈5 years) in the all-comer population and 53.5 mo in pts with PD-L1 IC0/1 tumours (IC2/3 median DOR not yet reached). Additional efficacy data by PD-L1 status are in the table.
Conclusions
In this 5-year clinical update from IMvigor210 Cohort 1 in cisplatin-ineligible mUC, durable responses and long-term survival with 1L atezolizumab monotherapy were seen. Median DOR was not reached in pts with PD-L1 IC2/3 mUC. Table: 699P
| All comers (N=119) | PD-L1 IC0/1 (n=87) | PD-L1 IC2/3 (n=32) | |
| ORR, n (%) [95% CI] | 28 (23.5) [16.2, 32.2] | 19 (21.8) [13.7, 32.0] | 9 (28.1) [13.8, 46.8] |
| CR, n (%) | 12 (10.1) | 7 (8.0) | 5 (15.6) |
| Ongoing responses, n/n (%)a | 15/28 (53.6) | 9/19 (47.4) | 6/9 (66.7) |
| Median DOR (95% CI), mo | 59.1 (44.2, NE) | 53.5 (30.4, NE) | NE (11.1, NE) |
| OS events, n (%) | 92 (77.3) | 68 (78.2) | 24 (75.0) |
| Median OS (95% CI), mo | 16.3 (10.4, 24.5) | 19.1 (10.4, 25.2) | 12.3 (6.0, 49.8) |
| 24-mo OS (95% CI), % | 41.1 (32.1, 50.2) | 41.8 (31.1, 52.5) | 39.3 (22.1, 56.5) |
| 60-mo OS (95% CI), % | 21.6 (13.7, 29.5) | 19.6 (10.8, 28.5) | 27.0 (10.3, 43.7) |
NE, not estimable. Response was per IRF in objective response (OR)–evaluable pts. a Refers to no death or PD only in pts who achieved an OR.
Clinical trial identification
NCT02951767.
Editorial acknowledgement
Medical writing assistance for this abstract was provided by Priscilla Hong, PharmD, of Health Interactions, Inc., and 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.E. Rosenberg: Financial Interests, Advisory Role: Astellas; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Bayer; Financial Interests, Advisory Role: Boehringer Ingelheim; Financial Interests, Advisory Role: BMS; Financial Interests, Advisory Role: EMD-Serono; Financial Interests, Advisory Role: Gilead/Immunomedics; Financial Interests, Advisory Role: GSK; Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Lilly; Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: QED; Financial Interests, Advisory Role: Roche/Genentech; Financial Interests, Advisory Role: Seattle Genetics; Financial Interests, Advisory Role: Tyra Biosciences; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Research Grant: QED; Financial Interests, Advisory Role: Mirati. M.D. Galsky: Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: EMD/Serono; Financial Interests, Advisory Role: BMS; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Seattle Genetics; Financial Interests, Advisory Role: Astellas; Financial Interests, Advisory Role: Genentech; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: AstraZeneca. A.V. Balar: Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Personal, Advisory Role: Genentech; Financial Interests, Personal, Invited Speaker: Genentech; Financial Interests, Personal, Advisory Role: Incyte; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Other, Steering/Scientific Advisory Committee: Merck; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: AstraZeneca/Medimmune; Financial Interests, Institutional, Research Grant: AstraZeneca/Medimmune; Financial Interests, Personal, Invited Speaker: AstraZeneca/Medimmune; Financial Interests, Personal, Advisory Role: Nektar; Financial Interests, Personal, Research Grant: Nektar; Financial Interests, Personal, Other, Steering Committee Membership: Nektar; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Institutional, Research Grant: Seagen; Financial Interests, Institutional, Research Grant: Immunomedics/Gilead; Financial Interests, Personal, Advisory Role: Immunomedics/Gilead; Financial Interests, Personal, Advisory Role: Istari Oncology; Financial Interests, Personal, Ownership Interest, Equity: EpiVax Oncology; Financial Interests, Personal, Other, Scientific Advisory Board Member: EpiVax Oncology. Y. Loriot: Financial Interests, Institutional, Research Grant: Jannsen; Financial Interests, Institutional, Research Grant: Celsius; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Personal, Other, Honoraria: Merck Kg; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: Janssen; Financial Interests, Personal, Other, Honoraria: Astellas; Financial Interests, Personal, Other, Honoraria: Seattle Genetics; Financial Interests, Personal, Other, Honoraria: Immunomedics; Financial Interests, Institutional, Other, Honoraria: BMS; Financial Interests, Institutional, Other, Honoraria: Pfizer; Financial Interests, Institutional, Other, Honoraria: Janssen; Financial Interests, Institutional, Other, Honoraria: Merck Kg; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: BMS; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: MSD; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Pfizer. A. Necchi: Financial Interests, Personal, Other, Honoraria; Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Honoraria; Travel, Accommodations, Expenses: Merck; Financial Interests, Personal, Other, Honoraria; Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Honoraria; Travel, Accommodations, Expenses: Janssen; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Honoraria: Foundation Medicine; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Rainier Therapeutics; Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Roche; Financial Interests, Advisory Role: Bayer; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Clovis Oncology; Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Incyte; Financial Interests, Advisory Role: Seattle Genetics/Astellas; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: Rainier Therapeutics; Financial Interests, Advisory Role: Glaxo Smith Kline; Financial Interests, Advisory Role: Ferring; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Ipsen. J. Hoffman-Censits: Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Seattle Genetics: Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Foundation Medicine. A. Drakaki: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: PACT Pharma; Financial Interests, Personal, Advisory Board: Roche/Genentech; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: BMS; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: Infinity; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: Kite Pharma; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: Merck; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: Roche; Financial Interests, Personal and Institutional, Principal Investigator, Local PI: Seattle Genetics. A. Javery: Financial Interests, Personal, Full or part-time Employment: Syneos Health. B. Nelson: Financial Interests, Personal, Full or part-time Employment: Genentech. H.X. Huang: Financial Interests, Personal, Full or part-time Employment: Genentech. X. Shen: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Genentech. M.S. van der Heijden: Financial Interests, Advisory Role: BMS; Financial Interests, Advisory Role: Roche; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Seagen; Financial Interests, Advisory Role: MSD; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Roche. All other authors have declared no conflicts of interest.