Roche nabs frontline OK for Avastin/Tecentriq in common liver cancer, besting an old Bayer drug
For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.
The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.
In that study, 84% of the 336 patients taking Avastin and Tecentriq combo were alive at 6 months, compared to 67.2% of the 165-patient Nexavar arm. At 12 months, 72.2% of the Roche patients were alive vs 54.6% for Nexavar.
“For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile,” lead investigator Richard Finn said in a statement, using the chemical name for Nexavar.
The approval is a major boon for Roche’s immunotherapy program, which, while producing a blockbuster, has nonetheless long lagged behind the market-leading drugs from Bristol Myers Squibb and Merck. Notably, Bristol Myers’ Opdivo failed last year to give patients statistically significant improved survival over Nexavar in the same setting, although that trial was as a monotherapy and the NJ pharma indicated they may try to pursue other frontline uses for the drug in HCC.
The new indication could also make a larger impact, both in revenue and for patients, than last week, when Tecentriq won approval as a monotherapy in non-small cell lung cancer by showing it could beat chemotherapy — years after Merck’s keytruda had done the same. Roche has been occupying a similar position in triple-negative breast cancer, after it became the first immunotherapy approved for that indication last year.
For Roche, though, the big questions now center on whether they can show that their anti-TIGIT molecule tiragolumab — the first of the second-generation checkpoint inhibitor and an area where Roche is ahead of the pack — improves on existing therapies. So far, the data have been mixed.
Photo: Richard Finn (Global Oncology Academy)