- Combining Roche’s cancer immunotherapy Tecentriq with the company’s older medicine Avastin helped people with liver cancer live longer without relapsing after surgery compared to no treatment, Roche said Thursday. The company claimed it’s the first time such a drug combination has shown a benefit in this setting.
- Roche did not release any specific data, but said it would submit results from the Phase 3 trial, called IMBrave050, to regulators in the U.S. and Europe. The Tecentriq-Avastin combination is already approved for liver cancer that can’t be surgically removed, where it competes with an AstraZeneca drug regimen.
- Liver cancer is an important setting for Tecentriq, accounting for 22% of the drug’s sales, according to Roche. The company reported sales of 2.7 billion Swiss francs ($2.9 billion) over the first nine months of 2022.
Liver cancer recurs in approximately 70% of people who are treated with surgery or ablation, a type of procedure that destroys tumors using heat. Until now, no post-surgical, or “adjuvant,” drug regimen has been shown to delay or prevent recurrence, including Bayer’s leading liver cancer drug Nexavar.
To test whether the Tecentriq-Avastin combination would work, Roche enrolled 660 people at high risk of having their disease return, randomizing half to receive the two drugs and half to undergo “active surveillance” for disease. Participants in the active surveillance group didn’t receive a placebo.
The trial’s main goal was “recurrence-free survival,” or how long patients went before their disease returned or death. Roche said that, at an interim data check, study monitors found treatment was associated with a statistically significant improvement in recurrence-free survival.
The study is also assessing overall survival, on which measure the Tecentriq combination hasn’t yet proven beneficial. Trial investigators will continue to assess survival over time.
“We are excited by the clinical benefit that this adjuvant Tecentriq combination may bring to people with early liver cancer and look forward to seeing more mature data to further confirm the benefit,” Levi Garraway, Roche’s chief medical officer, said in a statement.
IMBrave050 was one of two Tecentriq adjuvant trials that Roche executives recently highlighted as particularly important, along with a study in small-cell lung cancer.
An approval, if granted by the FDA or other regulators, would further separate Tecentriq from Merck & Co. and Bristol Myers Squibb’s top-selling immunotherapies Keytruda and Opdivo, which are approved only in patients whose disease has progressed after Nexavar treatment.