FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
| Autor: | Hong Zhao, Lisa Rodriguez, Kirsten B. Goldberg, Lola Fashoyin-Aje, Jiang Liu, Yuan Xu, Richard Pazdur, Yuan Li Shen, Sandra Casak, Martha Donoghue, Marc R. Theoret, Xiling Jiang, Shubhangi Mehta, Steven Lemery, Xiaoping Jiang, Paul G. Kluetz, William F. Pierce |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Sorafenib Adult Male Cancer Research medicine.medical_specialty Carcinoma Hepatocellular Bevacizumab Population Antibodies Monoclonal Humanized Gastroenterology 03 medical and health sciences 0302 clinical medicine Atezolizumab Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis education neoplasms Drug Approval Aged Aged 80 and over education.field_of_study Proteinuria business.industry Liver Neoplasms Middle Aged Confidence interval Diarrhea 030104 developmental biology Oncology 030220 oncology & carcinogenesis Drug and Narcotic Control Female medicine.symptom business Varices medicine.drug |
| Zdroj: | Clinical cancer research : an official journal of the American Association for Cancer Research. 27(7) |
| ISSN: | 1557-3265 |
| Popis: | On May 29, 2020, the FDA approved atezolizumab for use in combination with bevacizumab, for the treatment of adult patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior systemic treatment. The approval was based on data from Study IMbrave150, which randomly allocated (2:1) patients to receive either atezolizumab plus bevacizumab (atezolizumab-bevacizumab) or sorafenib. Overall survival (OS) and independently assessed progression-free survival (PFS) in the intent-to-treat population were the primary endpoints. At the time of the primary analysis, the estimated median OS could not be estimated in the atezolizumab-bevacizumab arm and was 13.2 months in the sorafenib arm [HR, 0.58; 95% confidence interval (CI), 0.42–0.79]. The estimated median PFS was 6.8 months (95% CI, 5.8–8.3) and 4.3 months (95% CI, 4.0–5.6) in the atezolizumab-bevacizumab and sorafenib arms, respectively. Adverse reactions occurring in >20% of patients receiving atezolizumab-bevacizumab were hypertension, fatigue/asthenia, and proteinuria. Adverse reactions occurring in >20% of patients receiving sorafenib were palmar-plantar erythrodysesthesia, diarrhea, hypertension, and decreased appetite. Hemorrhage was reported more frequently in patients receiving atezolizumab-bevacizumab (25%) than in patients receiving sorafenib (17%). An evaluation for the presence of varices is recommended within 6 months of initiation of atezolizumab-bevacizumab in patients with HCC. Approval of atezolizumab-bevacizumab is likely to change the treatment paradigm for HCC, given that treatment with atezolizumab-bevacizumab resulted in improved OS and PFS compared with sorafenib, an accepted standard of care for first-line treatment of patients with unresectable HCC. See related commentary by Castet et al., p. 1827 |
| Databáze: | OpenAIRE |
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