A combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) extends overall survival and the time lived without disease progression in people with newly-diagnosed, inoperable hepatocellular carcinoma (HCC), the most common type of liver cancer, compared to standard-of-care treatment with Nexavar (sorafenib), results from the IMbrave150 Phase 3 trial show.
Roche, which owns the rights to Tecentriq and Avastin, plans to submit these data to regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, to seek global approval of the combo treatment for this type of aggressive cancer.
HCC affects more than 750,000 people every year, with most cases occurring in Asia. In the U.S., HCC is the fastest rising cause of death from cancer.
The outlook for patients with advanced disease, those whose tumors cannot be removed by surgery (unresectable), is particularly poor. Few treatment options are available and less than 50% of the patients survive through the first year after diagnosis.
“We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a news release.
“HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world,” he said. “We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.”
IMbrave150 is a global Phase 3, open-label study (NCT03434379), launched by Roche in 2018 to test first-line treatment with Tecentriq and Avastin in people with HCC who have unresectable, locally advanced or metastatic (spread to other parts in the body) tumors and who have not been treated before with systemic therapy.
During the trial, a total of 501 patients were randomized to the Tecentriq-Avastin combo or standard-of-care treatment with oral Nexavar.
Tecentriq and Avastin were administered by vein injections on the first day of each 21-day cycle, while Nexavar tablets were given twice per day, every day of each cycle. Patients received the treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
According to Roche, the trial met its primary efficacy outcomes, or endpoints — the combo led to meaningful benefits by extending overall survival and prolonging progression-free survival, or the time patients lived without tumor growth.
Other secondary efficacy endpoints included in the study were overall response rate, time to progression, and duration of response, as well as patient-reported outcomes, safety, and pharmacokinetics (the agent’s uptake, availability, metabolism, distribution, and elimination in the body). Results from these outcomes were not disclosed yet.
The safety of Tecentriq-Avastin was consistent with what was described for the individual medications, with no new safety concerns identified.
More detailed data from the IMbrave150 study will be presented at an upcoming medical meeting, Roche reported.
In addition to IMbrave150, Roche is running a larger development program for Tecentriq, alone and in combination with other medications, for several types of solid cancers, including lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
In July 2018, the FDA granted Breakthrough Therapy Designation to Tecentriq-Avastin for HCC based on positive data from an ongoing Phase 1b trial (NCT02715531) evaluating Tecentriq in multiple combinations for a broad range of cancer types.
Tecentriq and Avastin are both anticancer biologics that are approved for certain types of solid cancers (excluding liver cancer) and sold by Genentech, a subsidiary of Roche.
Tecentriq belongs to a form of immunotherapy known as checkpoint inhibitors. It works by targeting a protein called PD-L1, which helps activate cancer-fighting immune cells.
Avastin is an antibody that specifically binds to a protein called VEGF. By doing so, it works as a tumor-starving agent that interferes with the tumor blood supply, helping to prevent tumor growth and spread.