Roche reported new data Friday from the Phase III IMbrave150 study showing that adding the PD-L1 inhibitor Tecentriq (atezolizumab) to Avastin (bevacizumab) reduced the risk of death by 42% and the risk of disease worsening or death by 41%, versus Bayer's Nexavar (sorafenib), in certain patients with unresectable hepatocellular carcinoma (HCC). Last month, Roche said the combination had achieved the trial's overall survival (OS) and progression-free survival (PFS) co-primary endpoints. The latest findings are scheduled for presentation at the European Society for Medical Oncology (ESMO) Asia Congress.
The IMbrave150 trial involved 501 patients with unresectable HCC who have not received prior systemic therapy. Participants were randomised to receive either the combination of Tecentriq and Avastin or standard-of-care with Nexavar alone. Along with the co-primary endpoints, the study also measured overall response rate, time to progression and duration of response as secondary objectives.
Roche said that median overall survival among patients treated with the combination of Tecentriq and Avastin has not yet been reached, but was 13.2 months in the Nexavar group. Meanwhile, median PFS was 6.8 months for patients given Tecentriq plus Avastin, compared with 4.3 months for Bayer's drug. In regards to safety, Roche noted that grade 3-4 adverse events occurred in 57% of patients receiving the combination regimen and 55% of those on Nexavar, while grade 5 adverse events occurred in 5% and 6% of patients, respectively.
Levi Garraway, chief medical officer and head of global product development at Roche, suggested that the combination of Tecentriq with Avastin "could transform the treatment of this aggressive disease, and we are working closely with global health authorities in the hope of bringing this treatment option to patients as soon as possible." The company has said the results would be submitted to regulators in the US, Europe and China.
Roche also noted that of the more than 750,000 patients worldwide diagnosed with HCC every year, the majority of cases are in Asia and almost half of all cases are in China.
Tecentriq is approved in multiple markets, including the US and Europe, either alone or in combination with targeted therapies and chemotherapies for various forms of non-small-cell and small-cell lung cancer, certain types of metastatic urothelial cancer and in patients with PD-L1-positive metastatic triple-negative breast cancer. Roche recently reported that sales of the drug gained 154% year-over-year to CHF 515 million ($516 million) in the third quarter.
For related analysis, see ViewPoints: Pivotal data point to synergistic role of Roche's Avastin, Tecentriq in liver cancer.
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