The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to atezolizumab and bevacizumab combination therapy as a first-line option for the treatment of patients with advanced or metastatic hepatocellular carcinoma (HCC), according to a press release.1
The FDA based its decision on results from a multicenter phase 1b (ClinicalTrials.gov Identifier: NCT02715531) study, for which researchers randomly assigned patients to 5 different treatment arms. Twenty-three evaluable, systemic therapy-naive patients with advanced HCC were assigned to arm A and received atezolizumab 1200 mg plus bevacizumab 15 mg/kg every 3 weeks.
After a median follow-up of 10.3 months, an independent review facility analysis showed that 65% (23) of patients had a response to treatment. All subgroups exhibited a response regardless of the etiology of their disease (eg, Hepatitis B, Hepatitis C, non-viral), region, high versus low baseline alpha-fetoprotein levels, or spread of tumor beyond the liver. Investigator assessments showed a response rate of 61% (14 patients).
Median duration of response, overall survival, progression-free survival, and time-to-progression were not yet evaluable at the current analysis.
In the safety evaluable population of 43 patients, grade 3 to 4 treatment-related adverse events (AE) were observed in 28% (12) of patients; no grade 5 AEs were reported.
Breakthrough therapy designation is granted to shorten the development and review period for therapies that treat serious or life-threatening conditions with limited treatment options.
- FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC) [press release]. Basel, Switzerland; Roche; July 18, 2018. http://hugin.info/174806/R/2205644/857058.pdf. Accessed July 18, 2018.