Abstract 1760P
Background
In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), patients (pts) with aUC that had not progressed with 1L platinum-based chemotherapy had significantly prolonged overall survival and progression-free survival with avelumab 1L maintenance + best supportive care (BSC) compared with BSC alone. Results led to avelumab 1L maintenance being approved worldwide and adopted into international treatment guidelines as standard of care. Here, we report long-term data from pts with ≥12 mo of avelumab 1L maintenance treatment as part of the JAVELIN Bladder 100 trial.
Methods
Eligible pts had unresectable locally advanced or metastatic UC that had not progressed with 1L platinum-based chemotherapy. This analysis included pts randomized to receive avelumab + BSC. Study treatment continued until confirmed progression, unacceptable toxicity, or withdrawal of consent.
Results
After a median follow-up of 38.0 mo in the avelumab arm (data cutoff June 4, 2021; ≥2 y in all pts), 118/350 pts (33.7%) had received ≥12 mo of treatment. Characteristics of these pts were similar to those in the overall avelumab arm (Table). Among all treated pts in the overall avelumab arm (N=344), grade ≥3 treatment-related adverse events (TRAEs) occurred in 67 (19.5%) and grade ≥3 immune-related AEs (irAEs) occurred in 26 (7.6%). Among pts treated for ≥12 mo (n=118), grade ≥3 TRAEs occurred after ≥12 mo in 14 (11.9%) and grade ≥3 irAEs occurred after ≥12 mo in 5 (4.2%). Efficacy outcomes will be presented.
Conclusions
In the JAVELIN Bladder 100 trial, prolonged avelumab 1L maintenance treatment was associated with a safety profile consistent with prior avelumab monotherapy studies, with no new safety signals identified with longer treatment duration. These results further support the use of avelumab 1L maintenance until progression for pts with aUC that has not progressed with 1L platinum-based chemotherapy. Table: 1760P
| Pts with ≥12 months of avelumab treatment (n=118) | Overall avelumab arm (N=350) | |
| Median age (range), years | 69 (43-86) | 68 (37-90) |
| Sex, n (%)MaleFemale | 91 (77.1)27 (22.9) | 266 (76.0)84 (24.0) |
| ECOG PS, n (%)012 | 83 (70.3)35 (29.7)0 | 213 (60.9)136 (38.9)1 (0.3) |
| Site of metastasis at start of chemotherapy, n (%)VisceralNonvisceral | 56 (47.5)62 (52.5) | 191 (54.6)159 (45.4) |
| Best response to 1L chemotherapy, n (%)CR or PRSD | 87 (73.7)31 (26.3) | 253 (72.3)97 (27.7) |
| PD-L1 status, n (%)PositiveNegativeUnknown | 72 (61.0)39 (33.1)7 (5.9) | 189 (54.0)139 (39.7)22 (6.3) |
CR, complete response; PR, partial response; SD, stable disease.
Clinical trial identification
NCT02603432; first posted, November 11, 2015.
Editorial acknowledgement
Full writing support to be disclosed - Medical writing support was provided by Jamie Ratcliffe of ClinicalThinking, and was funded by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
Legal entity responsible for the study
Pfizer, as part of an alliance between Pfizer and Merck.
Funding
Pfizer, as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
Disclosure
J.B. Aragon-Ching: Financial Interests, Personal, Advisory Role: Pfizer, Merck, MSD, Immunomedics, AVEO, Exelixis, Janssen, AZD; Financial Interests, Personal, Speaker’s Bureau: BMS, Astellas, Seattle Genetics, Pfizer, Merck. P. Grivas: Financial Interests, Personal, Advisory Role: AstraZeneca, Astellas Pharma, Bayer, Bristol Myers Squibb, Dyania Health, Merck, Exelixis, Foundation Medicine, Genentech/Roche, Genzyme, GlaxoSmithKline, Guardant Health, Gilead Sciences, Infinity Pharmaceuticals, Janssen, Lucence Health, MSD, Mirati Therapeutics, Pfizer, QED Therapeutics, Regeneron Pharmaceuticals, Seattle Genetics, SilverBack Therapeutics, UroGen, 4D Pharma PLC; Financial Interests, Institutional, Research Grant: Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm, Merck, G1 Therapeutics, Gilead Sciences, GlaxoSmithKline, MSD, Mirati Therapeutics, Pfizer, QED Therapeutics. Y. Loriot: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bristol Myers Squibb, Gilead, Janssen, Merck, MSD, Pfizer, Roche, Seattle Genetics, Tahio, Basilea; Financial Interests, Institutional, Principal Investigator: Astellas, AstraZeneca, Exelexis, Gilead, Incyte, Janssen, Merck, MSD, Pfizer; Financial Interests, Institutional, Research Grant: Celsius, Janssen, MSD, Roche, Sanofi; Financial Interests, Institutional, Advisory Board: Gilead/Immunomedics, Janssen, MSD. J. Bellmunt: Financial Interests, Personal, Other, Honoraria: Pfizer, Merck, BMS, AstraZeneca, Pierre Fabre; Financial Interests, Institutional, Other, Honoraria: Takeda, MSD; Financial Interests, Personal, Advisory Role: Pfizer, Merck, BMS, AstraZeneca, Roche/Genentech, Pierre Fabre; Financial Interests, Institutional, Research Grant: Takeda, Pfizer; Financial Interests, Personal, Other, Travel/Accommodations/Expenses: Pfizer; Financial Interests, Personal, Royalties: UpToDate. J. Wang: Financial Interests, Personal, Full or part-time Employment: Pfizer. E. Michelon: Financial Interests, Personal, Full or part-time Employment: Pfizer. A. di Pietro: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. T.B. Powles: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Merck, AstraZeneca, Ipsen, Pfizer, Novartis, Incyte, Seattle Genetics, Roche, Exelixis, MSD, Astellas Pharma, Johnson & Johnson, Eisai; Financial Interests, Personal, Other: Pfizer, MSD, AstraZeneca, Roche, Ipsen; Financial Interests, Personal, Research Grant: AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Ipsen, Merck, MSD, Novartis, Pfizer, Seattle Genetics, Astellas Pharma, Johnson & Johnson, Eisai. S. Sridhar: Financial Interests, Personal, Advisory Role: Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, MSD, Hoffmann-La Roche, Immunomedics, Ipsen, Janssen, Merck, Pfizer, Seagen, Seattle Genetics; Financial Interests, Personal, Research Grant: Bayer, Janssen, Seagen.