Abstract
Background: IMbrave150 is a phase III trial that assessed atezolizumab + bevacizumab (ATEZO/BEV) versus sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (HCC) and demonstrated a significant improvement in clinical outcomes. Exploratory analyses characterized objective response rate (ORR), depth (DpR), and duration of response (DoR), and patients with a complete response (CR). Methods: Patients were randomized 2:1 to intravenous ATEZO (1200 mg) + BEV (15 mg/kg) every 3 weeks or oral SOR (400 mg) twice daily. Tumors were evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and HCC-modified RECIST (mRECIST). ORR by prior treatment and largest baseline liver lesion size, DoR, time to response (TTR), and complete response (TTCR) were analyzed. Results: For both criteria, responses favored ATEZO/BEV versus SOR regardless of prior treatment and in patients with lesions ≥3 cm. Median TTR was 2.8 months per RECIST 1.1 (range: 1.2–12.3 months) and 2.8 months per mRECIST (range: 1.1–12.3 months) with ATEZO/BEV. Patients receiving ATEZO/BEV had a greater DpR, per both criteria, across baseline liver lesion sizes. Characteristics of complete responders were similar to those of the intent-to-treat population. In complete responders receiving ATEZO/BEV per mRECIST versus RECIST 1.1, respectively, median TTCR was shorter (5.5 vs. 7.0 months), mean baseline sum of lesion diameter was longer (5.0 [SD, 5.1] vs. 2.6 [SD, 1.4] cm), and mean largest liver lesion size was larger (4.8 [SD, 4.2] vs. 2.3 [SD, 1.0] cm). Conclusions: These data highlight the improved ORR, DpR, and CR rates with ATEZO/BEV in unresectable HCC.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 5437-5447 |
| Number of pages | 11 |
| Journal | Cancer medicine |
| Volume | 10 |
| Issue number | 16 |
| DOIs | |
| State | Published - Aug 2021 |
Funding
RS is a consultant for AstraZeneca, Boston Scientific, Cook, Eisai, Genentech, and Sirtex. DL has received fees for serving on a speakers bureau from Coherus Biosciences and Sun Pharmaceutical Industries; advisory board fees from Bayer Healthcare, Genentech, QED Therapeutics, and Taiho Pharmaceutical; fees for serving on a speakers bureau and advisory board from Advanced Accelerator Applications, Eisai, Exelixis, Ipsen Biopharmaceuticals, and Lexicon Pharmaceuticals; and a research grant to his institution from Brooklyn Immunotherapeutics. NS, SH, WV, and BD are employees and shareholders of Genentech, Inc. RL is a consultant for AstraZeneca, Eisai, and Genentech/Roche. This manuscript was sponsored by F. Hoffmann-La Roche Ltd. and Genentech, Inc. Support for third-party writing assistance was provided by F. Hoffmann-La Roche Ltd. We thank the patients and their families who participated in this study. We thank Yong Wang for his contributions to the statistical analysis. Third-party writing assistance was furnished by Christine Gould, PhD, CMPP, of Health Interactions, Inc.
Keywords
- Response Evaluation Criteria in Solid Tumors
- hepatocellular carcinoma
- immunotherapy
ASJC Scopus subject areas
- Oncology
- Radiology Nuclear Medicine and imaging
- Cancer Research
