Highlights
- •Data are limited on patients with autoimmune disease (AID) receiving immunotherapy.
- •SAUL evaluated atezolizumab in a broad population with urinary tract carcinoma.
- •Subgroup analyses of 35 atezolizumab-treated patients with AID were prespecified.
- •Treatment-related adverse events were manageable.
- •Treating AID patients with atezolizumab requires caution, but AID is not a barrier.
Abstract
Aim
Patients with pre-existing autoimmune disease (AID) are typically excluded from clinical
trials of immune checkpoint inhibitors, and there are limited data on outcomes in
this population. The single-arm international SAUL study of atezolizumab enrolled
a broader ‘real-world’ patient population. We present outcomes in patients with a
history of AID.
Methods
Patients with locally advanced/metastatic urinary tract carcinoma received atezolizumab
1200 mg every 3 weeks until loss of clinical benefit or unacceptable toxicity. The
primary end-point was safety. Overall survival (OS) was a secondary end-point. Subgroup
analyses of AID patients were prespecified.
Results
Thirty-five of 997 treated patients had AID at baseline, most commonly psoriasis (n = 15). Compared with non-AID patients, AID patients experienced numerically more adverse
events (AEs) of special interest (46% versus 30%; grade ≥3 14% versus 6%) and treatment-related
grade 3/4 AEs (26% versus 12%), but without relevant increases in treatment-related
deaths (0% versus 1%) or AEs necessitating treatment discontinuation (9% versus 6%).
Pre-existing AID worsened in four patients (11%; two flares in two patients); three
of the six flares resolved, one was resolving, and two were unresolved. Efficacy was
similar in AID and non-AID patients (median OS, 8.2 versus 8.8 months, respectively;
median progression-free survival, 4.4 versus 2.2 months; disease control rate, 51%
versus 39%).
Conclusions
In 35 atezolizumab-treated patients with pre-existing AID, incidences of special-
interest and treatment-related AEs appeared acceptable. AEs were manageable, rarely
requiring atezolizumab discontinuation. Treating these patients requires caution,
but pre-existing AID does not preclude atezolizumab therapy.
Trial registration
NCT02928406.
Keywords
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Article info
Publication history
Published online: September 06, 2020
Accepted:
July 19,
2020
Received in revised form:
July 13,
2020
Received:
May 1,
2020
Footnotes
☆Sources of support: The SAUL study and medical writing for this publication were funded by F Hoffmann-La Roche Ltd, Basel, Switzerland.
Identification
Copyright
© 2020 Elsevier Ltd. All rights reserved.
