Abstract 2600
Background
Atezo (anti–PD-L1) is approved for platinum-treated mUC and other indications. Here, we evaluated long-term OS and safety data from IMvigor211, a randomised study evaluating atezo monotherapy vs chemo in platinum-treated mUC (Powles Lancet 2018; primary analysis median follow-up: ≈ 17 mo).
Methods
Pts with disease progression during or following platinum-based chemo were assigned 1:1 to atezo 1200 mg or chemo (vinflunine, paclitaxel or docetaxel per investigator) IV q3w. OS (primary endpoint) and safety were evaluated descriptively in this ad hoc analysis.
Results
As of 8 Nov 2018, median follow-up was 34.3 mo. OS HRs were similar to those from the primary analysis. 24- and 30-mo OS rates were higher with atezo vs chemo in the intent-to-treat (ITT) and PD-L1 populations (Table). In ITT pts, OS HRs with atezo vs taxanes and vinflunine were 0.73 (95% CI: 0.59, 0.90) and 0.90 (95% CI: 0.74, 1.09), respectively. Grade 3-4 treatment-related adverse events (AEs) occurred in 22% of atezo-treated pts and 43% of chemo-treated pts (Grade 5 treatment-related AEs in 1% vs 2%, respectively). AEs leading to treatment discontinuation occurred in 9% of atezo-treated pts and 18% of chemo-treated pts. 11% of atezo-treated patients had a Grade 3-4 AE of special interest (vs 2% with chemo). 29% and 31% of pts in the atezo and chemo arms, respectively, received ≥ 1 subsequent non-protocol therapy; 8% in the chemo arm had non-protocol immunotherapy.Table:
918P OS in IMvigor211 ITT and PD-L1 populations
PD-L1 IC2/3 | PD-L1 IC1/2/3 | ITT | ||||
---|---|---|---|---|---|---|
Chemo n = 118 | Atezo n = 116 | Chemo n = 309 | Atezo n = 316 | Chemo n = 464 | Atezo n = 467 | |
Number of deaths (% of randomised pts) | 97 (82) | 85 (73) | 269 (87) | 261 (83) | 403 (87) | 386 (83) |
Median OS (95% CI), mo | 10.6 (8.4, 12.2) | 11.1 (8.6, 15.4) | 8.2 (7.4, 9.5) | 8.9 (8.2, 10.9) | 8.0 (7.2, 8.6) | 8.6 (7.8, 9.6) |
Stratified HR (95% CI) | 0.87 (0.64, 1.17) | 0.84 (0.70, 1.00) | 0.82 (0.71, 0.94) | |||
24-mo OS rate (95% CI) | 19% | 33% | 14% | 22% | 13% | 23% |
(12, 27) | (24, 42) | (10, 17) | (18, 27) | (10, 16) | (19, 26) | |
30-mo OS rate (95% CI) | 17% | 29% | 10% | 18% | 10% | 18% |
(10, 24) | (21, 38) | (7, 14) | (14, 23) | (7, 13) | (15, 22) |
Data cutoff, 8 Nov 2018. Median follow-up, 34.3 mo (range: 0-42.3). Stratification factors: PD-L1 status on tumour-infiltrating immune cells (IC), chemo type, liver metastases, and number of prognostic risk factors. PD-L1 status on IC evaluated per VENTANA SP142 assay.
Conclusions
In this long-term update from IMvigor211, including 24- and 30-mo OS rates, continued OS benefit in favor of atezo vs chemo was observed in the ITT population and in PD-L1 subgroups. No formal statistical comparisons were performed in this ad hoc analysis. Safety results were consistent with those in the primary analysis.
Clinical trial identification
NCT02302807.
Editorial acknowledgement
Jessica Men, PharmD, of Health Interactions, 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
M.S. 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. Y. Loriot: Advisory / Consultancy: Roche. I. Duran: Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Advisory / Consultancy: Pharmacyclycs; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): Astellas. A. Ravaud: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis. M.M. Retz: Full / Part-time employment: Technical University Munich, Germany. N.J. Vogelzang: Advisory / Consultancy, Shareholder / Stockholder / Stock options: Caris; Advisory / Consultancy: Merck; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Genentech; Advisory / Consultancy: Esai; Advisory / Consultancy: Tolero; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Exelixis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Clovis; Travel / Accommodation / Expenses: SWOG; Travel / Accommodation / Expenses: US Oncology. B. Nelson: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/GNE. J. Wang: Advisory / Consultancy, Full / Part-time employment: Roche/GNE. X. Shen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/GNE. T. Powles: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: F. Hoffmann-La Roche; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Travel / Accommodation / Expenses: Exelixis; Honoraria (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Travel / Accommodation / Expenses: Incyte; Honoraria (self), Travel / Accommodation / Expenses: Seattle Genetics.
Resources from the same session
2673 - Clinical activity of vofatamab (V), an FGFR3 selective antibody in combination with pembrolizumab (P) in metastatic urothelial carcinoma (mUC), updated interim analysis of FIERCE-22
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
3598 - Three-Year Follow-Up From the Phase 3 KEYNOTE-045 Trial: Pembrolizumab (Pembro) Versus Investigator’s Choice (Paclitaxel, Docetaxel, or Vinflunine) in Recurrent, Advanced Urothelial Cancer (UC)
Presenter: Andrea Necchi
Session: Poster Display session 3
Resources:
Abstract
2382 - First Report of Efficacy and Safety From a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma (UC) in Asian Patients
Presenter: Dingwei Ye
Session: Poster Display session 3
Resources:
Abstract
2388 - Quality of Life of Metastatic Urothelial Cancer (mUC) Patients Treated with Enfortumab Vedotin (EV) Following Platinum-Containing Chemotherapy and a Checkpoint Inhibitor (CPI): Data from EV-201 Cohort 1
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
3748 - Safety and efficacy of atezolizumab (atezo) in patients (pts) with autoimmune disease (AID): subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma
Presenter: Yohann Loriot
Session: Poster Display session 3
Resources:
Abstract
1126 - Validation of the VIO prognostic index in patients with metastatic urothelial carcinoma treated with immune-checkpoint inhibitors
Presenter: Rafael Morales Barrera
Session: Poster Display session 3
Resources:
Abstract
3693 - Pathologic outcomes after neoadjuvant chemotherapy for high-risk muscle invasive bladder cancer
Presenter: Justin Matulay
Session: Poster Display session 3
Resources:
Abstract
4840 - Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients (pts) with metastatic urothelial carcinoma (mUC)
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
1221 - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)
Presenter: Jean Hoffman-censits
Session: Poster Display session 3
Resources:
Abstract
1715 - National Small Cell Bladder Cancer Audit: Results from 26 UK institutions
Presenter: Caroline Chau
Session: Poster Display session 3
Resources:
Abstract