Abstract 3748
Background
Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic urothelial cancer. The pivotal IMvigor210 and IMvigor211 phase II and III trials excluded pts with significant pre-existing AID. The SAUL study (NCT02928406) in pts more representative of real-world practice showed median overall survival (OS) of 8.7 mo and safety consistent with previous atezo trials [Sternberg, Eur Urol 2019]. We analysed outcomes in pts with a history of AID.
Methods
Pts with locally advanced/metastatic urinary tract carcinoma, including pts ineligible for IMvigor211, received atezo 1200 mg q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety, including adverse events of special interest (AESIs) for atezo as defined in the protocol. OS was a secondary endpoint. Subgroup analyses of AID pts were prespecified.
Results
Of 1004 pts enrolled from Nov 2016 to Mar 2018, 997 received atezo. In 35 pts presenting with AID, the most common pre-existing conditions were psoriasis (n = 15), thyroid AID (n = 5) and rheumatoid arthritis (n = 4). Compared with non-AID pts, AID pts had numerically more AESIs (46% vs 30%; grade ≥3 14% vs 6%) and treatment-related grade 3/4 AEs (26% vs 12%), but there were no relevant increases in treatment-related deaths (0% vs 1%) or AEs leading to atezo discontinuation (9% vs 6%). Pre-existing AID worsened in 6 pts: flares subsequently improved or resolved in 4 pts (without stopping atezo in 3 pts) but were unresolved in 2 pts (rash in 1 pt continuing atezo, psoriasis in 1 pt who discontinued atezo). In the 962 non-AID pts, new immune-related AEs were infrequent (6% hypothyroidism, 4% hyperthyroidism, 2% pneumonitis, 1% colitis). Efficacy was similar in AID vs non-AID pts (median OS 8.2 vs 8.8 mo, respectively; 1-year OS 31% vs 42%; disease control 51% vs 39%; median PFS 4.4 vs 2.2 mo).
Conclusions
In 35 atezo-treated pts with pre-existing AID, incidences of AESIs and treatment-related AEs appeared acceptable. AEs were manageable and rarely led to atezo discontinuation. Treating these pts requires caution but AID is not a barrier to atezo therapy per se.
Clinical trial identification
NCT02928406.
Editorial acknowledgement
Jennifer Kelly (Medi-Kelsey Ltd), funded by F Hoffmann-La Roche.
Legal entity responsible for the study
F Hoffmann-La Roche.
Funding
F Hoffmann-La Roche.
Disclosure
Y. Loriot: Honoraria (self), Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution): Astellas; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Honoraria (institution): BMS; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Seattle Genetics; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Sanofi; Honoraria (self), Honoraria (institution): Clovis; Honoraria (institution): Incyte; Honoraria (self), Honoraria (institution): Pfizer; Licensing / Royalties, Pending patent (USA 62/455211, Europe 17209098.7): n/a. C.N. Sternberg: Advisory / Consultancy: MSD; Advisory / Consultancy: Clovis; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Incyte; Advisory / Consultancy: AstraZeneca; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Pfizer. D. Castellano Gauna: Advisory / Consultancy: Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy: Astellas; Advisory / Consultancy: Janssen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Exelisis; Advisory / Consultancy: Lilly. H. Dumez: Advisory / Consultancy: Janssen; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Jansen-Cilag; Travel / Accommodation / Expenses: Pfizer. R. Huddart: Honoraria (self), Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Nektar; Research grant / Funding (institution): Cancer Research UK. K.M. Vianna: Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy: Bayer; Advisory / Consultancy: Pfizer; Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: BMS. T. Alonso Gordoa: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony: IPSEN; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony: Novartis. I.A. Skoneczna: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Pfizer; Speaker Bureau / Expert testimony: IPSEN; Speaker Bureau / Expert testimony: BMS. A. Fay: Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Merck Sharp & Dohme. P. Maroto: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer; Advisory / Consultancy: Bristol-Myers Squibb. S.F. Oosting: Research grant / Funding (institution): Celldex; Research grant / Funding (institution): Novartis. S. Fear: Full / Part-time employment: F. Hoffmann-La Roche. F. Di Nucci: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/ Genentech. S. De Ducla: Shareholder / Stockholder / Stock options, Full / Part-time employment: F. Hoffmann-La Roche. E. Choy: Honoraria (self): AbbVie; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self): ObsEva; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self): Merck Serono; Honoraria (self), Speaker Bureau / Expert testimony: Regeneron; Honoraria (self), Advisory / Consultancy: Roche/Genentech; Honoraria (self): R-Pharm; Honoraria (self): SynAct Pharma; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Sanofi/Regeneron; Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Speaker Bureau / Expert testimony: UCB; Research grant / Funding (institution): Bio-Cancer Treatment International; Research grant / Funding (institution): Biogen. All other authors have declared no conflicts of interest.
Resources from the same session
3290 - Identification of meningioma patients in high risk of tumor recurrence using microRNA profiling
Presenter: Josef Srovnal
Session: Poster Display session 3
Resources:
Abstract
2477 - Antecedent of cancer and mortality after the first ST segment elevation acute myocardial infarction treated with primary coronary angioplasty. A prospective cohort study
Presenter: Irene Sillero
Session: Poster Display session 3
Resources:
Abstract
1894 - Genomic characterisation of locally advanced pancreatic adenocarcinoma
Presenter: Sarah Picardo
Session: Poster Display session 3
Resources:
Abstract
3280 - Comparison of freshly prepared and frozen cells from colorectal cancer surgical samples for phenotyping experiments- a pilot study
Presenter: Sandra Mersakova
Session: Poster Display session 3
Resources:
Abstract
3419 - Hyaluronan (HA) Accumulation in the Tumor Microenvironment (TME) is Increased in Colorectal Cancer (CRC) and Associated with Consensus Molecular Subtypes (CMS) 4 Molecular Subtype
Presenter: Barbara Blouw
Session: Poster Display session 3
Resources:
Abstract
1833 - Evaluation of CT-based radiomics in patients with renal cell carcinoma
Presenter: An Zhao
Session: Poster Display session 3
Resources:
Abstract
5883 - Detection of Double Protein Expression in Diffuse Large B Cell Lymphoma
Presenter: Mohamed Gouda
Session: Poster Display session 3
Resources:
Abstract
5415 - Encyclopedic Tumor Analysis for organ agnostic treatment with Axitinib in combination regimens for advanced cancers
Presenter: Tim Crook
Session: Poster Display session 3
Resources:
Abstract
3297 - Computational model to predict response rate of clinical trials
Presenter: Orsolya Lorincz
Session: Poster Display session 3
Resources:
Abstract
4355 - Analysis of BRCA genes and homologous recombination deficiency (HRD) scores in tumours from patients (pts) with metastatic breast cancer (mBC) in the OlympiAD trial
Presenter: Mark Robson
Session: Poster Display session 3
Resources:
Abstract