The approval for the Tecentriq, Avastin combination is for unresectable or metastatic HCC patients who did not receive prior systemic therapy. Both the drugs, which already have approvals for certain cancer indications, were developed by Genentech, a subsidiary of Roche.
According to Genentech, the Tecentriq, Avastin combination is now the first cancer immunotherapy regimen to have been approved by the FDA for the treatment of unresectable or metastatic hepatocellular carcinoma.
Tecentriq is a monoclonal antibody designed to inhibit the PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells. Avastin, on the other hand, is a biologic antibody that can specifically bind to the VEGF protein in order to interfere with the tumour blood supply.
Genentech chief medical officer and global product development head Levi Garraway said: “We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer.
“The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.”
The approval of the cancer immunotherapy regimen was driven by the findings of the phase 3 IMbrave150 study. The late-stage trial showed Genentech’s drug regimen to have cut down the risk of death, that is overall survival, by 42%, while bringing down the risk of disease worsening or death, that is progression-free survival, by 41%, in comparison to sorafenib.
UCLA David Geffen School of Medicine professor of medicine Richard Finn said: “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.
“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.”