IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study
Introduction: The Phase III IMbrave150 study established atezolizumab + bevacizumab as standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis reports efficacy and safety results in patients with baseline Barcelona Clinic Liver Cancer (BCLC) Stage B d...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2022-11-01
|
| Series: | Liver Cancer |
| Online Access: | https://www.karger.com/Article/FullText/528272 |
| _version_ | 1828089212610543616 |
|---|---|
| author | Masatoshi Kudo Richard S. Finn Peter R. Galle Andrew X. Zhu Michel Ducreux Ann-Lii Cheng Masafumi Ikeda Kaoru Tsuchiya Ken-ichi Aoki Jing Jia Riccardo Lencioni |
| author_facet | Masatoshi Kudo Richard S. Finn Peter R. Galle Andrew X. Zhu Michel Ducreux Ann-Lii Cheng Masafumi Ikeda Kaoru Tsuchiya Ken-ichi Aoki Jing Jia Riccardo Lencioni |
| author_sort | Masatoshi Kudo |
| collection | DOAJ |
| description | Introduction: The Phase III IMbrave150 study established atezolizumab + bevacizumab as standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis reports efficacy and safety results in patients with baseline Barcelona Clinic Liver Cancer (BCLC) Stage B disease.
Methods: Patients with systemic treatment-naive unresectable HCC and Child-Pugh Class A liver function were randomized 2:1 to receive 1200 mg of atezolizumab plus 15 mg/kg of bevacizumab or 400 mg of sorafenib. Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) per independent review facility (IRF)–assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in the BCLC Stage B subgroup. Patients in this analysis had BCLC Stage B disease at baseline per electronic case report form. Secondary efficacy endpoints included objective response rate (ORR) and change in the sum of longest diameter (SLD) of target lesions from baseline per IRF RECIST 1.1 and modified RECIST (mRECIST) for HCC.
Results: Of 501 enrolled patients, 74 (15%) had BCLC Stage B disease at baseline (atezolizumab + bevacizumab, n=49; sorafenib, n=24). For this group, median follow-up was 19.7 months. A trend toward improved OS and PFS per IRF RECIST 1.1 was observed with atezolizumab + bevacizumab vs sorafenib (OS: HR, 0.63; 95% CI: 0.29, 1.34; PFS: HR, 0.64; 95% CI: 0.36, 1.12). ORRs per IRF RECIST 1.1 and HCC mRECIST were 43% and 50% with atezolizumab + bevacizumab and 26% and 30% with sorafenib, respectively. Percentage change in SLD of target lesions from baseline per IRF RECIST 1.1 and HCC mRECIST showed durable responses with atezolizumab + bevacizumab treatment. Safety data were consistent with known profiles of atezolizumab and bevacizumab, as seen in the overall study population.
Discussion/Conclusion: Efficacy benefits were observed with atezolizumab + bevacizumab in patients with baseline BCLC Stage B disease, consistent with the intention-to-treat population. |
| first_indexed | 2024-04-11T05:35:34Z |
| format | Article |
| id | doaj.art-31036b7dbaf24a01b3e35c8cce37b1fc |
| institution | Directory Open Access Journal |
| issn | 2235-1795 1664-5553 |
| language | English |
| last_indexed | 2024-04-11T05:35:34Z |
| publishDate | 2022-11-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Liver Cancer |
| spelling | doaj.art-31036b7dbaf24a01b3e35c8cce37b1fc2022-12-22T12:25:03ZengKarger PublishersLiver Cancer2235-17951664-55532022-11-01110.1159/000528272528272IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III StudyMasatoshi Kudohttps://orcid.org/0000-0002-4102-3474Richard S. FinnPeter R. GalleAndrew X. ZhuMichel Ducreuxhttps://orcid.org/0000-0001-8649-7449Ann-Lii Chenghttps://orcid.org/0000-0002-9152-6512Masafumi Ikedahttps://orcid.org/0000-0002-4050-2086Kaoru Tsuchiyahttps://orcid.org/0000-0003-0436-5915Ken-ichi AokiJing JiaRiccardo LencioniIntroduction: The Phase III IMbrave150 study established atezolizumab + bevacizumab as standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis reports efficacy and safety results in patients with baseline Barcelona Clinic Liver Cancer (BCLC) Stage B disease. Methods: Patients with systemic treatment-naive unresectable HCC and Child-Pugh Class A liver function were randomized 2:1 to receive 1200 mg of atezolizumab plus 15 mg/kg of bevacizumab or 400 mg of sorafenib. Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) per independent review facility (IRF)–assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in the BCLC Stage B subgroup. Patients in this analysis had BCLC Stage B disease at baseline per electronic case report form. Secondary efficacy endpoints included objective response rate (ORR) and change in the sum of longest diameter (SLD) of target lesions from baseline per IRF RECIST 1.1 and modified RECIST (mRECIST) for HCC. Results: Of 501 enrolled patients, 74 (15%) had BCLC Stage B disease at baseline (atezolizumab + bevacizumab, n=49; sorafenib, n=24). For this group, median follow-up was 19.7 months. A trend toward improved OS and PFS per IRF RECIST 1.1 was observed with atezolizumab + bevacizumab vs sorafenib (OS: HR, 0.63; 95% CI: 0.29, 1.34; PFS: HR, 0.64; 95% CI: 0.36, 1.12). ORRs per IRF RECIST 1.1 and HCC mRECIST were 43% and 50% with atezolizumab + bevacizumab and 26% and 30% with sorafenib, respectively. Percentage change in SLD of target lesions from baseline per IRF RECIST 1.1 and HCC mRECIST showed durable responses with atezolizumab + bevacizumab treatment. Safety data were consistent with known profiles of atezolizumab and bevacizumab, as seen in the overall study population. Discussion/Conclusion: Efficacy benefits were observed with atezolizumab + bevacizumab in patients with baseline BCLC Stage B disease, consistent with the intention-to-treat population.https://www.karger.com/Article/FullText/528272 |
| spellingShingle | Masatoshi Kudo Richard S. Finn Peter R. Galle Andrew X. Zhu Michel Ducreux Ann-Lii Cheng Masafumi Ikeda Kaoru Tsuchiya Ken-ichi Aoki Jing Jia Riccardo Lencioni IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study Liver Cancer |
| title | IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study |
| title_full | IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study |
| title_fullStr | IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study |
| title_full_unstemmed | IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study |
| title_short | IMbrave150: Efficacy and Safety of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma—An Exploratory Analysis of the Phase III Study |
| title_sort | imbrave150 efficacy and safety of atezolizumab plus bevacizumab vs sorafenib in patients with barcelona clinic liver cancer stage b unresectable hepatocellular carcinoma an exploratory analysis of the phase iii study |
| url | https://www.karger.com/Article/FullText/528272 |
| work_keys_str_mv | AT masatoshikudo imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT richardsfinn imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT peterrgalle imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT andrewxzhu imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT michelducreux imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT annliicheng imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT masafumiikeda imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT kaorutsuchiya imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT kenichiaoki imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT jingjia imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy AT riccardolencioni imbrave150efficacyandsafetyofatezolizumabplusbevacizumabvssorafenibinpatientswithbarcelonacliniclivercancerstagebunresectablehepatocellularcarcinomaanexploratoryanalysisofthephaseiiistudy |