FDA approves Bristol Myers’ Opdivo-Yervoy combo for liver cancer

USA – Bristol Myers Squibb (BMS) has received another approval from the U.S. Food and Drug Administration (FDA) for its cancer-fighting drug combo, Opdivo and Yervoy.

This time, the combination is cleared as a first-line treatment for patients with advanced liver cancer — also known as hepatocellular carcinoma (HCC) — who cannot have surgery.

The approval is based on the results of the CheckMate-9DW clinical trial, where the Opdivo (nivolumab) and Yervoy (ipilimumab) combo helped patients live longer compared to standard drugs used to treat liver cancer.

Patients who received the immunotherapy combo had a 21% lower risk of death than those treated with either Bayer’s Nexavar or Eisai’s Lenvima, two commonly used tyrosine kinase inhibitors (TKIs).

Median survival was nearly 24 months with Opdivo and Yervoy, compared to around 21 months with the other treatments.

This marks a return for Opdivo in liver cancer treatment. The drug was previously approved for use after other treatments had failed but was pulled in 2021 when it didn’t meet expectations in follow-up trials.

Now, it is back as a first-choice option for newly diagnosed patients with advanced or spreading HCC.

Bristol Myers’ treatment will now compete with other immunotherapy options, including Roche’s Tecentriq paired with Avastin (bevacizumab), and AstraZeneca’s Imfinzi with Imjudo.

These combinations have also shown good results in patients with advanced liver cancer but haven’t proven as clearly effective in overall survival in some studies.

Dr. Aiwu Ruth He, one of the lead researchers in the CheckMate-9DW study from MedStar Georgetown University Hospital, said the new approval is a big step forward.

“Liver cancer rates have tripled in the last 40 years, and outcomes remain poor for many patients. This new treatment offers a real chance at longer survival,” she said.

According to researchers, the combination of two different immunotherapy drugs—Opdivo targeting PD-1 and Yervoy targeting CTLA-4—may offer a deeper, more lasting response than current options. They believe it has the potential to become the standard first-line treatment for advanced HCC.

However, there are some concerns. Yervoy, while effective, can cause more serious side effects, which might limit its use for some patients.

The Roche combo of Tecentriq and Avastin is considered easier to tolerate and may still be preferred for people who can’t handle stronger drugs.

The liver cancer approval comes shortly after the FDA also gave the green light to the Opdivo/Yervoy combo for certain types of advanced colon cancer that can’t be removed through surgery. This decision was based on results from the CheckMate-8HW trial.