Genentech touts positive Phase III data for Tecentriq/Avastin combo in liver cancer
The Tecentriq and Avastin combination met its primary endpoint — recurrence-free survival — for people with liver cancer, specifically early-stage hepatocellular carcinoma, in a Phase III study, Genentech announced Thursday.
The interim analysis of the Phase III IMbrave050 study showed “statistically significant” improvement in their target patients: people who have a high risk of the disease returning after they’ve had ablation or surgery to remove the cancer. This improvement was compared to patients who only had active surveillance.
However, no data from the 662-person study were provided by the Roche subsidiary. The company said the overall survival data were “immature,” and it will now discuss the results with the FDA and the European Medicines Agency and present them at a future medical meeting.
The trial participants received either 1,200 mg of Tecentriq every three weeks plus 15 mg of Avastin every three weeks for a maximum of 12 months, or had no intervention with active surveillance. Secondary endpoints include overall survival.
“IMbrave050 is the first Phase III study to show that a cancer immunotherapy combination reduced the risk of disease returning in people with this type of HCC,” Levi Garraway, chief medical officer and head of global product development at Genentech, said in a press release.
Nearly 42,000 Americans were diagnosed with liver cancer in 2022, according to the American Cancer Society’s estimate.
Tecentriq is a monoclonal antibody that inhibits PD-L1 and reactivates T cells. Avastin, a biologic antibody, binds to a specific protein in order to hamper a tumor’s blood supply and slow the growth of new blood cells by inhibiting VEGF-A.
Tecentriq is already approved alone or in combination with other drugs for non-small cell lung cancer, hepatocellular carcinoma if the disease can’t be removed through surgery, melanoma and soft tissue tumors.
In 2020, the FDA approved Avastin and Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma after Roche and Genentech published Phase III findings that showed the combo improved progression-free survival. It also helped patients live longer than the standard-of-care since 2007, Bayer’s Nexavar. The combo became the first immune checkpoint therapy to make it to the first line for these tumors.
However, in October 2021, the FDA pulled Tecentriq from its accelerated approval pipeline in combination with paclitaxel protein-bound for patients with locally advanced or metastatic triple-negative breast cancer. The FDA originally approved the drug combo in 2019 based on progression-free survival in a 902-person trial.
Other companies have entered the late stages of the immune checkpoint inhibitor space, including Merck and Eisai with Keytruda in combination with Lenvima; Jiangsu Hengrui and Elevar Therapeutics with PD-1 inhibitor camrelizumab alongside rivoceranib; and BeiGene with tislelizumab.