Who is this trial for?
This trial was for adults with advanced liver cancer (hepatocellular carcinoma) that could not be removed by surgery, who had not yet had any treatment that works throughout the body.
People in the trial had:
- Unresectable hepatocellular carcinoma (HCC) — the most common type of primary liver cancer, at a stage where surgery to remove it was not possible.
- No prior systemic therapy — this was their first drug treatment aimed at the whole body.
- Reasonably preserved liver function and general health.
What kind of trial is this?
This trial tested a new immunotherapy combination for treating advanced liver cancer. This report is a 5-year update — a look at how people were doing after the longest follow-up ever reported in a phase 3 liver-cancer study.
Background: why researchers asked this question
For years, advanced liver cancer was treated with tyrosine-kinase inhibitor pills such as sorafenib. They helped, but only modestly — and the outlook was poor, with fewer than 1 in 10 people alive at 5 years.
Immunotherapy changed the picture. Two types of immunotherapy work in complementary ways: drugs that block CTLA-4 (like tremelimumab) help the body build a fresh army of cancer-fighting T cells, while drugs that block PD-L1 (like durvalumab) stop tumors from switching those T cells off. Giving both is powerful but can be hard to tolerate. The STRIDE idea was clever: give the CTLA-4 drug only once — enough to prime the immune system — then rely on the gentler PD-L1 drug to maintain the response. HIMALAYA tested this against sorafenib.
The trial: what was tested and how
HIMALAYA enrolled 1,171 people with untreated, unresectable liver cancer. They were randomly assigned to one of three groups:
- STRIDE (393 people): one priming dose of tremelimumab plus durvalumab every 4 weeks.
- Durvalumab alone (389 people): the PD-L1 immunotherapy on its own.
- Sorafenib (389 people): the standard tyrosine-kinase inhibitor pill.
The main comparison was overall survival — how long people lived — for STRIDE versus sorafenib. This 5-year update looked at long-term survival after a median follow-up of about 5 years.
Results: what they found
STRIDE’s advantage over sorafenib held up — and grew — over five years. The hallmark of immunotherapy is a “tail” of long-term survivors, and that is exactly what appeared.
STRIDE vs sorafenib — long-term survival
About 1 in 5 people were alive at 5 years with STRIDE — more than double the rate with sorafenib. This was the first time a phase 3 liver-cancer trial reported 5-year survival.
Across the whole follow-up, STRIDE lowered the risk of death by about a quarter compared with sorafenib (HR 0.76).
Nearly twice as many people became long-term survivors — and no new safety problems appeared with the longer follow-up.
Durvalumab on its own was also about as good as sorafenib for survival (and easier to tolerate), but STRIDE — adding the single tremelimumab dose — gave the strongest long-term results. Because the stronger CTLA-4 drug was given only once, serious immune-related side effects were less common than with ongoing dual immunotherapy, though they still require careful monitoring.
Why does the survival benefit “grow” over time?
Chemotherapy and targeted pills mostly hold cancer back while you keep taking them. Immunotherapy can do something different: in a subset of people it retrains the immune system to keep the cancer in check for years, even after treatment. On a survival graph this shows up as a “tail” — a group of long-term survivors who pull the curves further apart the longer you look. That is why the 5-year gap (19.6% vs 9.4%) is proportionally larger than the early difference.
The bottom line
For advanced liver cancer, the STRIDE regimen — a single priming dose of tremelimumab plus ongoing durvalumab — more than doubled the chance of being alive at 5 years compared with sorafenib (19.6% vs 9.4%), and lowered the overall risk of death by about a quarter. It is the first treatment to show durable, multi-year survival for this disease, giving a meaningful share of patients years of life they would not otherwise have had.
What this could mean for you
- Immunotherapy is now a first-line option. Dual immunotherapy is one of the standard-of-care choices for advanced liver cancer, alongside other immunotherapy-based combinations.
- The “single dose” design matters. Giving the stronger drug only once aims to capture much of the benefit while limiting side effects.
- Some people do very well for a long time. The 5-year survivors show that durable control is possible, though it does not happen for everyone.
Related summaries: IMbrave150 and CheckMate 9DW — two other immunotherapy-based approaches for advanced liver cancer.
Questions & comments
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