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Durvalumab plus tremelimumab median PFS was 5.4 months in HIMALAYA eligible patientsPatients meeting specific criteria live longer with liver cancer treatment

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Key Takeaway
Note that patients meeting HIMALAYA eligibility criteria had longer median PFS and OS than those who did not.

This real-world clinical practice study evaluated 412 patients with unresectable hepatocellular carcinoma treated with durvalumab plus tremelimumab across 30 Japanese institutions. Patients were stratified into HIMALAYA and non-HIMALAYA groups based on their fulfillment of specific trial eligibility criteria.

In the HIMALAYA group, median progression-free survival (PFS) was 5.4 months, while the non-HIMALAYA group reached a median PFS of 3.0 months (p = 0.012). Median overall survival (OS) was 19.4 months in the HIMALAYA group versus 15.4 months in the non-HIMALAYA group (p = 0.014). Predictors for PFS included BMI $\geq$ 25 kg/m (HR 0.780; 95% CI [0.612-0.993]) and portal vein invasion (HR 1.509; 95% CI [1.049-2.170]). Predictors for OS included ECOG performance status $\geq$ 1 (HR 1.878; 95% CI [1.253-2.814]) and albumin-bilirubin grade $\geq$ 2 (HR 2.032; 95% CI [1.319-3.318]).

Safety data showed any-grade endocrine dysfunction in 14.1% of the HIMALAYA group and 6.6% of the non-HIMALAYA group. Grade $\geq$ 3 endocrine dysfunction occurred in 5.4% (HIMALAYA) and 0.6% (non-HIMALAYA). Due to the observational nature of this study, results should be interpreted as associations rather than definitive causal evidence.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in real-world outcomes for durvalumab plus tremelimumab in hepatocellular carcinoma. While previous coverage noted that direct-acting antivirals achieve an 89% SVR rate and reduce recurrence, this study provides specific data on the impact of HIMALAYA eligibility criteria on survival metrics in a real-world setting.

Living with advanced liver cancer, known as hepatocellular carcinoma, is a heavy burden. Doctors are constantly looking for ways to improve outcomes and manage the side effects of treatment. A real-world study involving 412 patients across 30 Japanese institutions looked at how specific health factors influenced those receiving a combination of two drugs: durvalumab and tremelimumab.

The researchers compared patients who met certain criteria (the HIMALAYA group) against those who did not. They found that the HIMALAYA group had a much longer progression-free survival, meaning their cancer stayed stable for a longer period. These patients also lived longer overall than those in the non-HIMALAYA group. The study noted that factors like body mass index and specific liver conditions played a significant role in these outcomes.

While the results are promising, it is important to remember this was an observational study of real-world practice rather than a controlled trial. This means we can see patterns, but we cannot prove one factor caused another. Additionally, some patients with good liver function in the non-HIMALAYA group may have had similar survival rates to those in the HIMALAYA group. Talk to your doctor about how these findings apply to your specific health profile.

What this means for you:
Patients meeting certain clinical criteria saw longer survival and slower cancer growth during treatment.

Common questions

How long did the treatment keep the cancer from progressing?

In this study, patients in the HIMALAYA group had a median progression-free survival of 5.4 months. In comparison, those in the non-HIMALAYA group had a median progression-free survival of 3.0 months.

What were the safety risks of this treatment?

The study reported endocrine dysfunction, which affects hormones. This occurred in 14.1% of the HIMALAYA group and 6.6% of the non-HIMALAYA group. More serious cases (Grade 3 or higher) occurred in 5.4% of the HIMALAYA group and 0.6% of the non-HIMALAYA group.

What factors influenced how long patients lived?

The study found that a body mass index of at least 25 was linked to better outcomes. Conversely, an ECOG performance status of 1 or higher and an albumin-bilirubin grade of 2 or higher were associated with worse overall survival.

Study Details

Study typePhase3
Sample sizen = 412
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
BACKGROUND AND AIM: This study evaluated clinical outcomes in patients with hepatocellular carcinoma (HCC) treated with durvalumab plus tremelimumab (Dur/Tre) in routine practice, stratified by whether they fulfilled the eligibility criteria of the phase 3 HIMALAYA trial. METHODS: A total of 412 patients with unresectable HCC receiving Dur/Tre at 30 Japanese institutions were enrolled. Of these, 92 fulfilled the HIMALAYA trial eligibility criteria (HIMALAYA group) and 320 did not (non-HIMALAYA group). RESULTS: Median progression-free survival (PFS) was 5.4 months in the HIMALAYA group and 3.0 months in the non-HIMALAYA group (p = 0.012). Multivariable analysis identified body mass index ≥ 25 kg/m (hazard ratio [HR], 0.780; 95% confidence interval [CI], 0.612-0.993; p = 0.044) and portal vein invasion (HR, 1.509; 95% CI, 1.049-2.170; p = 0.027) as independent predictors of PFS. Median overall survival (OS) was 19.4 months in the HIMALAYA group versus 15.4 months in the non-HIMALAYA group (p = 0.014). Multivariable analysis showed Eastern Cooperative Oncology Group performance status ≥ 1 (HR, 1.878; 95% CI, 1.253-2.814; p = 0.002) and albumin-bilirubin grade ≥ 2 (HR, 2.032; 95% CI, 1.319-3.318; p = 0.001) as independent determinants of OS. Any-grade endocrine dysfunction occurred in 13 (14.1%) and 21 (6.6%) patients (p = 0.030), with grade ≥ 3 events in 5 (5.4%) and 2 (0.6%), respectively (p = 0.007). Subgroup analysis suggested that non-HIMALAYA patients with ALBI grade 1 may have OS comparable to the HIMALAYA group. CONCLUSIONS: Patients fulfilling the HIMALAYA trial eligibility criteria and those who did not but had preserved hepatic function demonstrated favorable survival outcomes with Dur/Tre.
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