FDA Grants Breakthrough Therapy Designation for Genentech's Tecentriq in Combination With Avastin as First-Line Treatment for Advanced or Metastatic HCC

July 18, 2018—Genentech, a member of the Roche Group, announced that the FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab; Genentech) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma (HCC). The designation is based on data from a phase 1b study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. 

Genentech presented data from the phase 1b study at the 2018 American Society of Clinical Oncology annual meeting held June 1–5 in Chicago, Illinois.

According to the company, these data showed that after a median follow-up of 10.3 months, responses (independent review facility per RECIST [Response Evaluation Criteria In Solid Tumors] v1.1) were seen in 15 (65%) of 23 efficacy-evaluable participants. All subgroups experienced response, including based on etiology (hepatitis B, hepatitis C, and nonviral), region (Asia [excluding Japan] or Japan/United States), baseline alpha-fetoprotein levels (high/low), or spread of tumor beyond the liver (yes/no).

The response rate based on RECIST v1.1 was 61% (14 out of 23 participants). Median progression-free survival, duration of response, time to progression, and overall survival have not yet been reached after a median follow-up of 10.3 months. Results will be presented in the future when updated data from an expanded cohort are available. In the safety-evaluable population (n = 43), 28% of participants (n = 12) experienced grade 3 to 4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed.

No new safety signals were identified beyond the established safety profiles for the individual medicines. Genentech provided additional data per FDA request, and the Breakthrough Therapy Designation has been granted based on the totality of these data, advised the company.