Roche could soon be looking at a liver cancer nod in previously untreated patients, thanks to a big clinical showing that put Bayer’s go-to therapy on notice.
A combination of Tecentriq and fellow Roche drug Avastin cut the risk of death by 42% and of disease progression or death by 41% compared with Bayer’s standard-of-care Nexavar in a phase 3 trial in people with hepatocellular carcinoma (HCC)—the most common form of liver cancer—that can't be surgically removed, Roche unveiled at the European Society for Medical Oncology (ESMO) Asia meeting.
Results showed the 336 new liver cancer patients on the Roche regimen were living long enough that the median overall survival had not yet been reached at the time of analysis. In comparison, Nexavar extended 165 patients’ lives by a median of 13.2 months, consistent with the drug’s known performance.
This marks the first time in a decade that a treatment has improved survival benefits in this patient population, according to Roche’s chief medical officer Levi Garraway, and the data's inclusion in the congress' presidential session itself was testimony to the combo’s potential to shift the way patients are treated.
“Tecentriq in combination with Avastin could transform the treatment of this aggressive disease, and we are working closely with global health authorities in the hope of bringing this treatment option to patients as soon as possible,” he said.
Indeed, in a separate head-to-head study that landed Eisai and partner Merck & Co.’s Lenvima a first-line liver cancer nod last year, the drug posted a 13.6-month overall survival benefit, only marginally topping Nexavar’s 12.3 months.
The win from the trial, called IMbrave150, also put Tecentriq ahead of its PD-1/L1 rivals. Market-leading PD-1s, namely Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, have both recently fallen short in their late-stage liver cancer trials.
Keytruda, in the Keynote-240 study, couldn't top placebo at keeping cancer at bay among previously treated patients. And in the CheckMate 459 trial, Opdivo couldn't significantly beat out Nexavar at extending the lives of previously untreated patients, posting median survival of 16.4 months compared with Nexavar's 14.7 months.
However, it’s worth noting that both PD-1s flopped as monotherapies, while Tecentriq success came in tandem with Avastin. At least Merck and Eisai are planning to follow suit, having secured an FDA breakthrough designation for the Keytruda-Lenvima combo for first-line HCC based on positive interim readouts from the phase 1b Keynote-524 study.
One key market that all liver cancer drugs would be vying for is China. With an estimated 365,000 new incidences each year, China makes up about half of all newly diagnosed HCC cases worldwide. And in the IMbrave150 trial, the Roche pairing did even better among non-Japanese Asians, paring down the risk of death by 47%.
Lenvima as a first-line HCC treatment has been on the Chinese market for over a year now, and the drug is said to be among about 150 drugs in negotiation for national reimbursement, with an announcement expected soon. Meanwhile, Tecentriq is awaiting its initial approval in the country.