On April 27, 2026, AstraZeneca announced that China’s National Medical Products Administration (NMPA) has officially approved its dual immunotherapy regimen—tremelimumab（Imjudo®） in combination with durvalumab（Imfinzi®）—for the first-line treatment of adult patients with advanced or unresectable Hepatocellular carcinoma (HCC).

This milestone not only reinforces the role of immunotherapy combinations in liver cancer, but also provides a new standardized treatment option in the first-line setting.

As a key bridge between global innovative therapies and end markets, DengYueMed continues to monitor this approval and evaluates its clinical value, global accessibility, and market implications from a supply chain perspective.

From Global Validation to China Approval: A Mature Dual-Immunotherapy Strategy

The approved regimen combines tremelimumab, a CTLA-4 inhibitor, with durvalumab, a PD-L1 inhibitor.

This dual immune checkpoint strategy works by activating the immune system at different stages: CTLA-4 blockade enhances early T-cell priming, while PD-L1 inhibition restores anti-tumor immune activity within the tumor microenvironment. Together, they provide a more robust and sustained immune response.

Globally, the regimen has followed a clear regulatory pathway:

● Approved by the FDA in 2022 (Imjudo + Imfinzi) for      first-line treatment of unresectable HCC

● Subsequently approved in Japan and the European Union

● Now approved in China, completing coverage across major markets

This trajectory reflects consistent efficacy across populations and strengthens its clinical positioning worldwide.

HIMALAYA Trial: The STRIDE Regimen Design

The approval is primarily based on the global Phase III HIMALAYA trial, which introduced the innovative STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

The regimen is designed to balance efficacy and safety through an induction-plus-maintenance approach:

● Induction phase: a single high dose of tremelimumab (300 mg) to rapidly activate the immune system

● Maintenance phase: durvalumab (1500 mg every 4 weeks) to sustain immune response and control tumor progression

This approach minimizes cumulative toxicity associated with continuous CTLA-4 inhibition while preserving therapeutic benefit.

In the global population, the STRIDE regimen demonstrated a significant overall survival (OS) benefit compared with sorafenib:

● Median OS: 16.4 months vs. 13.8 months

● 22% reduction in risk of death (HR = 0.78)

Durvalumab monotherapy also met the predefined non-inferiority criterion (HR = 0.86), offering an alternative for patients less suitable for combination therapy.

China Subgroup: Enhanced Long-Term Survival Benefit

In the China-specific cohort, the STRIDE regimen showed even more pronounced efficacy, which is particularly relevant given the high prevalence of HBV-related HCC in this population.

Key findings include:

● Median OS: 25.3 months vs. 14.1 months (sorafenib)

● Survival benefit exceeding 11 months

● 40% reduction in risk of death (HR = 0.60)

● 3-year OS rate: 40.6%, approximately double that of the control group

These results suggest a stronger immunological response in this patient population and highlight the potential for long-term disease control with dual immunotherapy.

Safety Profile: Balancing Efficacy and Tolerability

Importantly, the STRIDE regimen did not lead to increased high-grade toxicity and demonstrated a more favorable safety profile compared to sorafenib.

Rates of Grade ≥3 treatment-related adverse events (TRAEs):

● STRIDE: 24.1%

● Durvalumab monotherapy: 12.4%

● Sorafenib: 40.2%

Clinically, this improved tolerability is attributed to reduced CTLA-4 exposure and the manageable nature of immune-related adverse events, which can typically be controlled with standard interventions such as corticosteroids. This makes the regimen suitable for long-term treatment.

CTLA-4: From Pioneer to Key Combination Partner

CTLA-4 was the first immune checkpoint validated in oncology. In 2011, Ipilimumab became the first approved CTLA-4 inhibitor, marking the beginning of the immuno-oncology era.

Although PD-1/PD-L1 inhibitors later became dominant, CTLA-4 has re-emerged as a critical component in combination regimens.