FDA approves Tecentriq + Avastin for people with unresectable or metastatic hepatocellular carcinoma . Genentech/Roche

Genentech, a member of the Roche Group announced that the FDA has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. “The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr. Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. “For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile.” The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under Project Orbis. Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. imbrave150 is the first phase iii cancer immunotherapy study to show an improvement in os and pfs in people with unresectable or metastatic hcc compared with sorafenib. serious adverse reactions grade 3-4 occurred in 38 of people in the tecentriq and avastin arm. the most frequent serious adverse reactions 2 were bleeding in the gastrointestinal tract infections and fever. these results were published in the new england journal of medicine on may 14 2020. see-atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma.- richard s. finn m.d. shukui qin m.d. masafumi ikeda m.d. peter r. galle m.d. michel ducreux m.d. . kaseb m.d. daneng li m.d. wendy verret ph.d. et al. for the imbrave150 investigators-may 14 2020 n engl j med 2020 382:1894-1905 doi: 10.1056 nejmoa1915745.>