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
2494 - CAR-T Nursing Education at a UK Specialist Cancer Hospital
Presenter: Rose Ellard
Session: Poster Display session 3
Resources:
Abstract
2438 - Professional Quality of Life, Perceived Stress and Psychological Resistance Levels of Oncology-Hematology Nurses and the Factors Affecting
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
3541 - Representation of cancer survivors’ preferences in policies for supportive care: Implications for oncology nursing
Presenter: Samantha Mayo
Session: Poster Display session 3
Resources:
Abstract
5093 - Vaginal moisturizing post PDR-Pulse Dose Rate Brachytherapy.
Presenter: Pilar Fernández
Session: Poster Display session 3
Resources:
Abstract
1066 - The stomized, chemo and radiotreated patient vs untreated patient: complications and comparison with data literature
Presenter: Cristoforo Ferrero
Session: Poster Display session 3
Resources:
Abstract
1724 - Evaluating the role of clinical nurse specialist
Presenter: Anita Zeneli
Session: Poster Display session 3
Resources:
Abstract
3753 - Role of the Advanced Practice Nurse (APN) in a Functional Unit for Lung cancer at the Catalan Institute of Oncology
Presenter: Isabel Brao
Session: Poster Display session 3
Resources:
Abstract
2676 - A bottom-up approach for prioritising the scientific activities of the Italian Association of Cancer Nurses (AIIAO): rationale and topic identification
Presenter: Valentina Biagioli
Session: Poster Display session 3
Resources:
Abstract
575 - Investigating quality of care for people with cancer and dementia
Presenter: Naomi Farrington
Session: Poster Display session 3
Resources:
Abstract
5578 - Two years of BRCA1 and BRCA2 somatic External Quality Assessment with Gen&tiss Tiss scheme in France
Presenter: Kelly Dufraing
Session: Poster Display session 3
Resources:
Abstract