Abstract
Original language | English |
---|---|
Pages (from-to) | 7-11 |
Number of pages | 5 |
Journal | European Urology |
Volume | 80 |
Issue number | 1 |
Early online date | 2021 |
DOIs | |
Publication status | Published - Jul 2021 |
Keywords
- Atezolizumab
- Cancer immunotherapy
- Overall survival
- Urothelial carcinoma
Access to Document
Other files and links
Cite this
- APA
- Author
- BIBTEX
- Harvard
- Standard
- RIS
- Vancouver
}
In: European Urology, Vol. 80, No. 1, 07.2021, p. 7-11.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial
AU - van der Heijden, Michiel S.
AU - Loriot, Yohann
AU - Durán, Ignacio
AU - Ravaud, Alain
AU - Retz, Margitta
AU - Vogelzang, Nicholas J.
AU - Nelson, Betty
AU - Wang, Jingjing
AU - Shen, Xiaodong
AU - Powles, Thomas
N1 - Funding Information: Financial disclosures: Michiel S. van der Heijden certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Michiel S. van der Heijden has received institutional research funding from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, and Roche; institutional fees for consulting or advisory roles from Astellas Pharma, AstraZeneca/MedImmune, Bristol Myers Squibb, Janssen, MSD Oncology, and Roche/Genentech; and travel, accommodation, and other expenses from Astellas Pharma, MSD Oncology, Novartis, and Roche. Yohann Loriot has received institutional research funding from AstraZeneca, Boehringer Ingelheim, Clovis Oncology, CureVac, Exelixis, Incyte, Janssen Oncology, Medivation, MSD Oncology, Nektar, Oncogenex, Pfizer, and Sanofi; honoraria from Pfizer and Sanofi; fees for consulting or advisory roles from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Clovis Oncology, Janssen, MSD Oncology, Roche, and Seattle Genetics; and travel, accommodation, and other expenses from Astellas Pharma, AstraZeneca, Janssen Oncology, MSD Oncology, Roche, and Seattle Genetics. Ignacio Durán has received institutional research funding from Astellas Pharma, AstraZeneca Spain, Janssen Oncology, and Roche/Genentech; honoraria from Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen Oncology, MSD Oncology, and Roche/Genentech; fees for consulting or advisory roles from Bayer, Bristol Myers Squibb, Janssen Oncology, MSD Oncology, Novartis, Pharmacyclics, Roche/Genentech, and Seattle Genetics; and travel, accommodation, and other expenses from AstraZeneca Spain and Roche/Genentech. Alain Ravaud has received institutional research funding from Pfizer; honoraria from Bristol Myers Squibb, Ipsen, Novartis, and Pfizer; fees for consulting or advisory roles from AstraZeneca, Bristol Myers Squibb, Ipsen, Novartis, Pfizer, and Roche; and travel, accommodation, and other expenses from AstraZeneca, Bristol Myers Squibb, Ipsen, MSD, Novartis, Pfizer, and Roche. Margitta Retz has nothing to disclose. Nicholas J. Vogelzang is an employee of US Oncology; has received institutional research funding from Endocyte, Merck, Suzhou Kintor Pharmaceuticals, and US Oncology; has received honoraria from Novartis, Pfizer, and UpToDate; has received fees for consulting or advisory roles from Astellas Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Caris Life Sciences, Clovis Oncology, Corvus Pharmaceuticals, Eisai, Genentech/Roche, Janssen Oncology, Merck, Modra, Pfizer, and Tolero Pharmaceuticals; has received fees for participating in speaker bureaus or providing expert testimony for Bayer, Bristol Myers Squibb, Genentech/Roche, Sanofi, and Novartis; holds stock or other ownership interests in Caris Life Sciences; and has received travel, accommodation, and other expenses from AstraZeneca/MedImmune, Bayer/Onyx, Exelixis, Genentech/Roche, Pfizer, Sanofi/Aventis, and US Oncology. Betty Nelson and Jingjing Wang are employees of Genentech. Xiaodong Shen is an employee of and holds stock or other ownership interests in Genentech. Thomas Powles has received research funding from AstraZeneca/MedImmune and Roche/Genentech; honoraria from AstraZeneca, Bristol Myers Squibb, Ferring, GLG Group, Janssen Research & Development, Merck, Novartis, Pfizer, Roche/Genentech, and Seattle Genetics/Astellas; fees for consulting or advisory roles from AstraZeneca, Bristol Myers Squibb, Genentech/Roche, Incyte, Ipsen, Merck, Novartis, Pfizer, and Seattle Genetics; and travel, accommodation, and other expenses from AstraZeneca, Bristol Myers Squibb, Ferring, MSD, Novartis/Ipsen, Pfizer, Research to Practice, and Roche/Genentech. Funding Information: Acknowledgments: Third-party writing assistance for this manuscript was provided by Jeff Frimpter, MPH, of Health Interactions with financial support from F. Hoffmann-La Roche Ltd . Funding Information: Funding/Support and role of the sponsor: This study was sponsored by F. Hoffmann-La Roche Ltd. and Genentech, Inc., a member of the Roche Group. The sponsor played a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. Publisher Copyright: © 2021 European Association of Urology
PY - 2021/7
Y1 - 2021/7
N2 - Atezolizumab is an anti–PD-L1 immune checkpoint inhibitor recommended for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) after prior platinum-containing chemotherapy, regardless of PD-L1 status, among other treatment settings. We conducted a long-term follow-up to the exploratory analysis of overall survival (OS) and safety for the IMvigor211 intent-to-treat (ITT) population. Patients with mUC and disease progression during or following platinum-based chemotherapy were randomised 1:1 to receive atezolizumab 1200 mg or chemotherapy (vinflunine 320 mg/m2, paclitaxel 175 mg/m2, or docetaxel 75 mg/m2 according to investigator choice) intravenously every 3 wk. Although the primary analysis did not demonstrate statistically significant longer OS for patients receiving atezolizumab versus chemotherapy, updated OS showed long-term durable remission. With a median of 33 mo of follow-up, the 24-mo OS rate was 23% with atezolizumab and 13% with chemotherapy. Safety findings were consistent with the primary analysis, with no new signals detected. Chemotherapy-treated patients experienced more grade 3/4 treatment-related adverse events (AEs; 43% vs 22%) and more AEs leading to treatment discontinuation (18% vs 9%). Atezolizumab-treated patients experienced more AEs of special interest (35% vs 20%), which tended to be grade 1–2. Our findings support the use of atezolizumab in platinum-treated patients with mUC regardless of PD-L1 status. Patient summary: We report follow-up results from a study of an immunotherapy treatment, atezolizumab, in patients with bladder cancer who had already received platinum-containing chemotherapy. This analysis compared the effectiveness of atezolizumab with chemotherapy over 2.5 years after starting treatment. The results show that patients who received atezolizumab lived longer and had manageable side effects compared with patients who received chemotherapy. This trial is registered at ClinicalTrials.gov as NCT02302807.
AB - Atezolizumab is an anti–PD-L1 immune checkpoint inhibitor recommended for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) after prior platinum-containing chemotherapy, regardless of PD-L1 status, among other treatment settings. We conducted a long-term follow-up to the exploratory analysis of overall survival (OS) and safety for the IMvigor211 intent-to-treat (ITT) population. Patients with mUC and disease progression during or following platinum-based chemotherapy were randomised 1:1 to receive atezolizumab 1200 mg or chemotherapy (vinflunine 320 mg/m2, paclitaxel 175 mg/m2, or docetaxel 75 mg/m2 according to investigator choice) intravenously every 3 wk. Although the primary analysis did not demonstrate statistically significant longer OS for patients receiving atezolizumab versus chemotherapy, updated OS showed long-term durable remission. With a median of 33 mo of follow-up, the 24-mo OS rate was 23% with atezolizumab and 13% with chemotherapy. Safety findings were consistent with the primary analysis, with no new signals detected. Chemotherapy-treated patients experienced more grade 3/4 treatment-related adverse events (AEs; 43% vs 22%) and more AEs leading to treatment discontinuation (18% vs 9%). Atezolizumab-treated patients experienced more AEs of special interest (35% vs 20%), which tended to be grade 1–2. Our findings support the use of atezolizumab in platinum-treated patients with mUC regardless of PD-L1 status. Patient summary: We report follow-up results from a study of an immunotherapy treatment, atezolizumab, in patients with bladder cancer who had already received platinum-containing chemotherapy. This analysis compared the effectiveness of atezolizumab with chemotherapy over 2.5 years after starting treatment. The results show that patients who received atezolizumab lived longer and had manageable side effects compared with patients who received chemotherapy. This trial is registered at ClinicalTrials.gov as NCT02302807.
KW - Atezolizumab
KW - Cancer immunotherapy
KW - Overall survival
KW - Urothelial carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85105180235&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.eururo.2021.03.024
DO - https://doi.org/10.1016/j.eururo.2021.03.024
M3 - Article
C2 - 33902955
SN - 0302-2838
VL - 80
SP - 7
EP - 11
JO - European Urology
JF - European Urology
IS - 1
ER -