Abstract 704P
Background
Programmed death 1/ligand 1 inhibitors (PD-1/L1i) are indicated for first-line (1L) therapy in aUC patients who are cisplatin-ineligible and have high PD-L1 expression or who are ineligible for any platinum-containing chemotherapy regardless of PD-L1 status. Current, real-world data on PD-1/L1i use in 1L are limited. This study characterized 1L treatment patterns and subsequent second-line (2L) therapy in both cisplatin-eligible and ineligible patients with aUC.
Methods
Patients aged ≥18 years diagnosed with aUC (Stage IV UC) from May 2016–July 2020 were included; activity in the nationwide Flatiron Health de-identified electronic health record-derived database ≤90 days post-aUC diagnosis date (index) was required. The cohort received 1L therapy on/after index, with follow-up through October 2020. Patient characteristics and 1L/2L treatment patterns were described in the population overall and by cisplatin eligibility (defined per Galsky criteria).
Results
4,063 patients were included; 3,119 (76.8%) received 1L therapy, with median follow-up of 8.5 (IQR 3.9-17.1) months. Mean age of patients at aUC diagnosis was 72.2 years; 72.6% were male; 1,229 (39.4%) received a 1L PD-1/-L1i. Approximately half of 1L treated patients were cisplatin-ineligible (50.9%). A higher proportion of cisplatin-ineligible (50.1%) than cisplatin-eligible (28.3%) patients were treated with PD-1/-L1i in 1L (Table). Only 42.5% of treated patients received 2L therapy, with differences based on the type of 1L therapy received: 24.6% following 1L PD-1/L1i vs 54.5% following 1L chemotherapy. Table: 704P
| 1L Treated Patients (n=3,119) | 1L Cisplatin-Ineligible (n=1,588) | 1L Cisplatin-Eligible (n=1,531) | |
| Male, n (%) | 2264 (72.6) | 1070 (67.4) | 1194 (78.0) |
| Age at aUC diagnosis, mean (SD) | 72.2 (9.0) | 75.0 (7.9) | 69.4 (9.2) |
| 1L therapy type, n (%) | |||
| PD-1/-L1 inhibitor | 1229 (39.4) | 796 (50.1) | 433 (28.3) |
| Carboplatin-based | 791 (25.4) | 435 (27.4) | 356 (23.3) |
| Cisplatin-based | 772 (24.8) | 220 (13.9) | 552 (36.1) |
| Other chemotherapy | 219 (7.0) | 89 (5.6) | 130 (8.5) |
| Clinical trial | 59 (1.9) | 24 (1.5) | 35 (2.3) |
| Other | 49 (1.6) | 24 (1.5) | 25 (1.6) |
| Post 1L, n (%) | |||
| Received 2L therapy | 1326 (42.5) | 585 (36.8) | 741 (48.4) |
| Still on 1L | 212 (6.8) | 98 (6.2) | 114 (7.4) |
| No therapy post 1L | 473 (15.2) | 197 (12.4) | 276 (18.0) |
| Died after 1L | 1108 (35.5) | 708 (44.6) | 400 (26.1) |
Conclusions
Approximately 3/4 of patients received systemic treatment following aUC diagnosis, with PD-1/-L1i accounting for ∼40% of 1L regimens. Following 1L PD-1/L1i, a lower proportion (∼1/4) of patients received 2L therapy relative to those treated with 1L chemotherapy (∼1/2). There remains significant unmet need for safe and efficacious therapies for patients with aUC following 1L PD-1/L1i therapy.
Clinical trial identification
Editorial acknowledgement
Editorial support was provided by Ann Cameron of Curo, a division of Envision Pharma Group, and funded by Seagen Inc. and Astellas Pharma Inc.
Legal entity responsible for the study
Seagen Inc., Bothell, WA, USA and Astellas Pharma, Inc. Northbrook, IL, USA.
Funding
Seagen Inc. and Astellas Pharma Inc.
Disclosure
A.K. Morgans: Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Sanofi; Financial Interests, Advisory Role: Astellas Pharma; Financial Interests, Advisory Role: Bayer; Financial Interests, Advisory Role: Clovis Oncology; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Advanced Accelerator Applications; Financial Interests, Advisory Role: Myovant Sciences; Financial Interests, Research Grant: Bayer; Financial Interests, Research Grant: Seagen/Astellas Pharma; Financial Interests, Research Grant: AstraZeneca; Financial Interests, Research Grant: Astellas Scientific and Medical Affairs; Financial Interests, Research Grant: Myovant Sciences; Financial Interests, Other, Travel, accommodation, expenses: Sanofi; Financial Interests, Advisory Role: Astellas Scientific and Medical Affairs; Financial Interests, Advisory Role: Janssen Oncology. M.D. Galsky: Financial Interests, Advisory Role: Aileron Therapeutics; Financial Interests, Advisory Role: Astellas; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: BioMotiv; Financial Interests, Advisory Role: BMS; Financial Interests, Advisory Role: Dendreon; Financial Interests, Advisory Role: Dracen; Financial Interests, Advisory Role: EMD Serono; Financial Interests, Advisory Role: Genentech; Financial Interests, Advisory Role: GSK; Financial Interests, Advisory Role: Incyte; Financial Interests, Advisory Role: Inovio Pharma; Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Lilly; Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Novartis; Financial Interests, Advisory Role: NuMab; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: Seagen; Financial Interests, Ownership Interest: Rappta Therapeutics; Financial Interests, Research Grant: BMS; Financial Interests, Research Grant: Dendreon; Financial Interests, Research Grant: Genentech; Financial Interests, Research Grant: AstraZeneca; Financial Interests, Royalties, Methods and compositions for treating cancer and related Methods (20120322792): Patent/Royalties; Financial Interests, Research Grant: Janssen; Financial Interests, Research Grant: Merck; Financial Interests, Research Grant: Novartis. Z. Hepp: Financial Interests, Personal, Stocks/Shares: Seagen Inc.; Financial Interests, Personal, Full or part-time Employment: Seagen Inc. N.N. Chang: Financial Interests, Personal, Full or part-time Employment: Seagen Inc.; Financial Interests, Personal, Stocks/Shares: Seagen Inc. M. Campbell: Financial Interests, Personal, Full or part-time Employment: Seagen Inc.; Financial Interests, Personal, Stocks/Shares: Seagen Inc. H.S. Wirtz: Financial Interests, Personal, Full or part-time Employment: Seagen Inc.; Financial Interests, Personal, Stocks/Shares: Seagen Inc. R. Fuldeore: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma. S. Sesterhenn: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma; Financial Interests, Personal, Stocks/Shares: Merck; Financial Interests, Personal, Stocks/Shares: Seagen Inc. A. Surinach: Financial Interests, Institutional, Funding: Seagen Inc. Y. Liu: Financial Interests, Institutional, Funding: Seagen Inc. G.P. Sonpavde: Financial Interests, Advisory Role: Genentech; Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Eisai; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Janssen; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: Exelixis; Financial Interests, Advisory Role: EMD Serono; Financial Interests, Advisory Role: Astellas Pharma; Financial Interests, Advisory Role: Bicycle Therapeutics; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: Seagen Inc.; Financial Interests, Advisory Role: G1 Therapeutics; Financial Interests, Advisory Role: Scholar Rock; Financial Interests, Other, Honoraria: UptoDate; Financial Interests, Other, Honoraria: Elsevier Practice update editor; Financial Interests, Speaker’s Bureau: Physicans' Education Resource; Financial Interests, Speaker’s Bureau: OncLive; Financial Interests, Speaker’s Bureau: Research to Practice; Financial Interests, Speaker’s Bureau: Medscape; Financial Interests, Other, Travel, accommodations, expenses: Bristol-Myers Squibb; Financial Interests, Research Grant: Janssen; Financial Interests, Research Grant: AstraZeneca; Financial Interests, Research Grant: Sanofi; Financial Interests, Other, Research support: Gilead; Financial Interests, Other, Research support: Bristol-Myers Squibb; Financial Interests, Other, Research support: Sanofi; Financial Interests, Other, Research support: AstraZeneca; Financial Interests, Other, Research support: QED; Financial Interests, Other, Research support: Predicine.