After years of having the previously untreated liver cancer market all to itself, Bayer’s Nexavar is getting its first major competition—and it’s coming from Roche’s Tecentriq.
The FDA Friday cleared a combination of the checkpoint inhibitor and fellow Roche med Avastin for previously untreated patients with hepatocellular carcinoma, the most common form of the disease. The approval is the first for a member of the PD-1/L1 class, which has so far struggled to make inroads in liver cancer.
Regulators based the green light on data from the phase 3 Imbrave150 study, which showed the combo cut the risk of death by 42% and the risk of disease progression or death by 41% compared with Bayer’s standard-of-care med. And those numbers are “quite significant” against an active control, lead investigator Richard Finn, M.D., said ahead of the OK.
“We never had anything that beat the standard of care in front-line until this regimen,” he said, pointing out that Eisai and Merck’s Lenvima, which also bears a nod in the population, won its FDA approval with data showing it matched up to Nexavar but didn't beat it.
The tough-to-treat cancer has also historically posed a challenge in terms of upping patient response rates, Finn said. But the Tecentriq-Avastin duo’s ability to provoke a response in 27% of study patients was a standout. Responses also proved durable, keeping disease in check for patients for a longer period of time.
Finn attributes the increase in response rate to the combination approach. Avastin on its own “doesn’t do much” in the setting—“We looked at bevacizumab a decade ago in liver cancer,” he said, referring to the drug by its generic name—and solo checkpoint inhibitors haven’t found much success, either. Both Merck’s Keytruda and Bristol Myers Squibb’s Opdivo flopped monotherapy trials in the disease.
“The combination clearly has some synergistic anti-tumor effect that is leading to these benefits,” Finn said.
But Roche isn’t alone in exploring combinations for newly diagnosed liver cancer patients. For one, Merck and Eisai are trialing a tandem of Keytruda and Lenvima, and they revealed ahead of the American Society of Clinical Oncology virtual annual meeting that the pairing had spurred a benefit in 36% of phase 1b study patients.
It's the Swiss drugmaker that's arrived first, though, and Roche can get to work snapping up market share.
"I think this will be taken up pretty quickly because the efficacy data is quite impressive," Finn said.