Roche touts industry-first liver cancer win, expects more Tecentriq adjuvant data this year

For Roche’s immunotherapy Tecentriq, 2023 is expected to be a prolific year filled with clinical trial readouts in early-stage cancers. In the first trial in the series, Tecentriq has delivered a win.

Nearly three years after snatching a first-in-class FDA approval in metastatic liver cancer, a combination of Roche’s Tecentriq and Avastin posted a first-in-class win in early-stage disease. The combo significantly reduced the risk of tumor recurrence compared with simple surveillance when used as adjuvant treatment following surgery in people with hepatocellular carcinoma at a high risk of rebound, Roche said Thursday.

Roche plans to discuss the results from the phase 3 IMbrave050 study with drug regulators, including the U.S. FDA and the European Medicines Agency.

The study is the first phase 3 trial for an immunotherapy combo to show tumor recurrence benefits in early-stage liver cancer, Roche’s chief medical officer Levi Garraway, M.D., Ph.D., noted in a statement. More than 70% of early-stage liver cancer patients may see their cancer return after surgery, and recurrence is linked with shorter survival, he noted.

Before the adjuvant liver cancer readout, the Tecentriq-Avastin combo in 2020 became the first immunotherapy regimen approved in newly diagnosed metastatic liver cancer. That came after the combo showed it could extend patients’ lives compared with Bayer’s Nexavar.

As expected for an early-stage cancer trial, IMbrave050’s data on patients’ life expectancy remained immature at the interim analysis. Roche said the study will continue to allow for further follow-up.

Investigators plan to share detailed data at an upcoming medical meeting, Roche said. Industry watchers will look for the magnitude of the recurrence-free survival benefit, as well as subgroup data, especially by PD-L1 expression levels. Recurrence-free survival in PD-L1-positive disease is a secondary endpoint of IMbrave050.

Previously, unbalanced performance in various PD-L1 subgroups limited Tecentriq’s historic FDA approval as an adjuvant therapy in early-stage non-small cell lung cancer. There, although Tecentriq showed an improvement in the overall trial population, the benefit was almost entirely driven by PD-L1-positive patients. That’s the group for whom Roche filed and got approved in.

Meanwhile, the IMbrave050 trial win marks a redemption for Tecentriq in the adjuvant setting after the PD-L1 inhibitor last year failed to move the needle in adjuvant kidney cancer.

Roche has several more adjuvant study readouts coming in 2023. These include the phase 3 IMpower030 trial, which is testing Tecentriq, first in combination with chemotherapy before surgery, then as a monotherapy after surgery in early-stage non-small cell lung cancer.

During a conference call in October, Roche's former pharma chief Bill Anderson highlighted the current liver cancer trial and the perioperative NSCLC study as the near-term adjuvant readouts that Roche has “the most hope in.” Noting that the Tecentriq-Avastin combo is a “really powerful regimen” in the metastatic setting, Anderson said Roche hoped to get “a very strong result” in adjuvant liver cancer.

In addition, Roche also expects data this year from the phase 3 IMvoke010 study of Tecentriq and chemotherapy in adjuvant head and neck cancer. The phase 3 IMpassion030 trial, which compares the combination of Tecentriq and chemo versus chemo alone in operable triple-negative breast cancer, could also report results in 2023, although Roche has previously guided a readout in 2024.