Overall survival (OS) by response to first-line (1L) induction treatment with atezolizumab (atezo) + platinum/gemcitabine (plt/gem) vs placebo + plt/gem in patients (pts) with metastatic urothelial carcinoma (mUC): Updated data from the IMvigor130 OS final analysis.

Authors

Enrique Grande

Enrique Grande

MD Anderson Cancer Center, Madrid, Spain

Enrique Grande , Aristotelis Bamias , Matt D. Galsky , Eiji Kikuchi , Ian D. Davis , José A. Arranz , Arash Rezazadeh , Xavier Garcia del Muro , Se Hoon Park , Ugo De Giorgi , Boris Alekseev , Marina Mencinger , Kouji Izumi , Javier Puente , Jian-Ri Li , Chooi Lee , Sandrine Bernhard , Alan Nicholas , Julie Telliez , Maria De Santis

Organizations

MD Anderson Cancer Center, Madrid, Spain, National and Kapodistrian University of Athens, Athens, Greece, Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan, Eastern Health Clinical School, Monash University and Eastern Health, Melbourne, Australia, Gregorio Marañón University General Hospital, Madrid, Spain, University of California Irvine, Irvine, CA, Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"– IRST, Meldola, Italy, Regional Oncology Institute, Tomsk, Russian Federation, Institute of Oncology Ljubljana, Ljubljana, Slovenia, Kanazawa University Hospital, Kanazawa, Japan, Medical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain, Taichung Veterans General Hospital, Taichung City, Taiwan, Roche Products Limited, Welwyn Garden City, United Kingdom, Genentech Inc, South San Francisco, CA, Roche, Basel, Switzerland, Department of Urology, Charité University Hospital, Berlin, Germany, Berlin, Germany

Research Funding

Pharmaceutical/Biotech Company
F. Hoffman La-Roche

Background: For pts without disease progression during 1L plt-based chemotherapy (chemo), maintenance immunotherapy is a new mUC treatment option. IMvigor130 was a global, randomized Phase III study evaluating 1L atezo + plt/gem (Arm A) vs atezo monotherapy (Arm B) and placebo + plt/gem (Arm C) in patients with mUC (Galsky Lancet 2020). The final analysis showed that improved OS in Arm A vs Arm C of the intention-to-treat (ITT) population did not reach statistical significance (Galsky ASCO GU 2023). Here we report a post hoc analysis examining OS outcomes by response during atezo/placebo + chemo “induction” based on the final OS analysis. Methods: For Arms A and C, per protocol, investigators pre-specified the type of chemo pts received (gem + either cisplatin [cis] or carboplatin [carbo]), which was also a randomization stratification factor. Pts without progressive disease (PD) were allowed to continue atezo or placebo after 4 to 6 cycles of plt/gem. This post hoc analysis evaluated post-induction (Wk 18) OS in pts who completed 4 to 6 cycles of chemo followed by ≥1 dose of atezo or placebo and who had a best response of at least stable disease (SD) without PD at any time (up to and including Wk 18 tumor assessment). Post-progression OS was evaluated in pts who had PD at any time (up to and including Wk 18 tumor assessment). OS analyses by type of chemo were also performed. Multivariable Cox proportional hazards models were used, with HRs adjusted for known prognostic factors (and response for non-PD pts) and stratified by enrollment stage. Results: The time from last pt randomized to the data cutoff (Aug 31, 2022) was 49 mo (overall ITT population). OS improvements favoring Arm A vs C appeared greater for pts treated with cis than with carbo. In the cis subgroup, OS rates at 36 mo were 47% (Arm A) and 34% (Arm C) for pts who achieved at least SD during induction. Additional efficacy data are shown. Conclusions: In this post hoc analysis, the initial response to induction therapy did not seem to impact OS outcomes. Consistent with prior analyses, these data suggest that cis-treated pts may derive a greater benefit from the addition of atezo than carbo-treated pts. Clinical trial information: NCT02807636.

ArmPost-induction OS: Pts without PDPost-progression OS: Pts with PD
nOS
events, %
Median OS,
mo
36-mo OS,
%
OS HR
(95% CI)
nOS events,
%
Median OS, mo36-mo OS, %OS HR
(95% CI)
ITTA1667020.5350.84
(0.63, 1.10)
91924.360.75
(0.54, 1.05)
C1527419.62693903.35
CisA575828.4470.68
(0.41, 1.11)
29906.680.56
(0.30, 1.04)
C596819.93433912.59
CarboA1097618.5280.92
(0.66, 1.29)
62943.850.77
(0.51, 1.17)
C937919.62160903.42

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Genitourinary Cancer—Kidney and Bladder

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Urothelial Cancer - Advanced/Metastatic Disease

Clinical Trial Registration Number

NCT02807636

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 4503)

DOI

10.1200/JCO.2023.41.16_suppl.4503

Abstract #

4503

Abstract Disclosures