On September 27, Roche presented the results of a Phase Ib study on the efficacy and safety of Tecentriq (atezolizumab) in combination with bevacizumab for the treatment of unresectable hepatocellular carcinoma (HCC) in patients who had not received prior systemic therapy at the 2019 European Society for Medical Oncology (ESMO) Congress.
Study results showed that the combination of Tecentriq and bevacizumab achieved an objective response rate (ORR) of 36% in patients with unresectable hepatocellular carcinoma who had not previously received systemic therapy; compared with Tecentriq monotherapy, it reduced the risk of disease progression or death by 45%.
According to data from the non-randomized cohort (Group A) receiving Tecentriq in combination with bevacizumab, patients demonstrated clinically meaningful and durable responses after a median follow-up of 12.4 months. The objective response rate (ORR), confirmed by central assessment per RECIST v1.1 criteria, was 36%. The data also showed that 12% of patients achieved a complete response, and the median duration of response (DOR) reached the secondary endpoint. Regarding safety, the profile was consistent with the known safety characteristics of each monotherapy.
The randomized portion of the study (Cohort F) compared the efficacy of Tecentriq in combination with bevacizumab versus Tecentriq monotherapy. The primary endpoint, progression-free survival (PFS) assessed by independent review facility per RECIST v1.1 criteria, was met, demonstrating a 45% reduction in the risk of disease progression or death with the combination therapy compared to Tecentriq monotherapy. After a median follow-up of 6.6 months, results indicated that Tecentriq plus bevacizumab was superior to Tecentriq monotherapy. The median PFS was 5.6 months for the combination therapy versus 3.4 months for monotherapy. Other secondary endpoints for Cohort F are still under evaluation, and the data are currently immature. The safety profile of Cohort F was consistent with that of Cohort A, with no new safety signals identified.
Tecentriq was granted Priority Review status on March 15, 2016, for the second-line treatment of locally advanced or metastatic urothelial carcinoma, and received FDA approval on October 18, 2016, becoming the first marketed PD-L1 monoclonal antibody. In July 2018, based on data from this Phase Ib study, the FDA granted Breakthrough Therapy Designation (BTD) to Tecentriq in combination with bevacizumab for the first-line treatment of advanced or metastatic hepatocellular carcinoma (HCC).