Imfinzi® is also approved as monotherapy for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC).
This approval is based on results from the global Phase III HIMALAYA clinical trial and its China cohort. The results demonstrate that the STRIDE regimen and Imfinzi® monotherapy exhibit a favorable benefit-risk profile compared to sorafenib.
ShanghaiApril 27, 2026 /PRNewswire/ — AstraZeneca announced today that the China National Medical Products Administration (NMPA) has officially approved Imfinzi® (generic name: durvalumab) in combination with Imjudo® (generic name: tremelimumab) for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC). Additionally, durvalumab monotherapy has also been approved as a first-line treatment for adult patients with advanced or unresectable HCC.
Primary liver cancer is a significant contributor to cancer-related deaths worldwide[1]. In China, nearly 320,000 deaths from HCC occurred in 2022 alone, ranking second in both mortality numbers and rates among malignant tumors[2]. Due to its insidious onset and lack of early symptoms, most patients are diagnosed at an intermediate or advanced stage when surgical resection is no longer a viable first option[3]. Previous first-line standard therapies have faced issues such as limited efficacy and poor tolerability, leaving patient treatment needs unmet[4] and creating a long-standing diagnostic and therapeutic bottleneck.
As a new oncology drug approved by AstraZeneca this year, tremelimumab is the first and only* approved IgG2 subtype CTLA-4 antibody. Its IgG2 structure enhances treatment safety and can remodel myeloid cells, improving the tumor immune microenvironment[5][6][7]. The combination therapy employs a dosing strategy previously explored to achieve an optimal benefit-risk profile: a single priming dose of tremelimumab combined with fixed-interval durvalumab (STRIDE, Single Tremelimumab Regular Interval Durvalumab). This approach uses a priming dose of tremelimumab to fully stimulate T-cell expansion and initiate the body’s anti-tumor immune response while avoiding the increased toxicity associated with continuous dosing. This mechanistic uniqueness allows the STRIDE regimen to maintain good safety while ensuring the efficacy of the dual immunotherapy combining anti-CTLA-4 and anti-PD-L1[8].
This approval by the NMPA is based on positive results from the global Phase III HIMALAYA study and its China cohort. Global cohort data showed that compared to sorafenib monotherapy, the STRIDE regimen significantly reduced the risk of death by 22% (hazard ratio [HR] 0.78; 95% confidence interval [CI], 0.66-0.92; p=0.0035). The median overall survival (OS) was 16.4 months in the STRIDE combination group versus 13.8 months in the sorafenib group. Durvalumab monotherapy demonstrated non-inferior OS benefit compared to sorafenib (HR 0.86; 95% CI, 0.73-1.02), with a pre-specified non-inferiority margin of 1.08 (based on the upper limit of the 95.67% CI). The median OS in the durvalumab monotherapy group was 16.6 months.
Analysis of the China cohort from the HIMALAYA study showed a clear trend of long-term benefit with the STRIDE regimen, consistent with the global benefit trend. The median OS in the STRIDE combination group was 25.3 months, extending by over 11 months compared to the sorafenib group (median OS 14.1 months), with a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.42-0.84). The 3-year OS rate was 40.6%, approximately double that of the sorafenib control group[9]. In terms of safety, both the STRIDE regimen and durvalumab monotherapy demonstrated good safety and tolerability. Data showed that the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 24.1% in the STRIDE group and 12.4% in the durvalumab monotherapy group, both lower than the 40.2% in the sorafenib group.
Notably, the HIMALAYA study is the first global Phase III trial of dual immunotherapy for unresectable HCC and the first and only** Phase III registrational study in the first-line treatment of unresectable HCC to report 5- and 6-year follow-up results. The 6-year OS rate was 17.1% for the STRIDE combination regimen versus 8.9% for the sorafenib group[10], results presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
Professor Shukui Qin, Qiantang Scholar, Director of the Institute of Clinical Medicine at Qiantang Advanced Research Institute, and China Lead Investigator for HIMALAYA, stated: “As the Phase III clinical study with the longest reported survival follow-up in the field of unresectable liver cancer treatment, the HIMALAYA study’s China cohort holds special significance: the baseline HBV infection rate among patients is as high as 75%, reflecting the real-world disease characteristics of liver cancer often accompanied by hepatitis B infection in China. These patients with a high HBV infection burden have more severe immunosuppression. The STRIDE regimen features a unique design and mechanism. Tremelimumab selects the IgG2 subtype to enhance safety. Through tremelimumab’s unique single priming dose administration, it fully initiates the body’s anti-tumor immunity early in treatment, breaks early immune tolerance, and reshapes the patient’s immune microenvironment. Under maintenance therapy with durvalumab, it achieves sustained activation of the immune response, demonstrating good efficacy and preservation of liver function. The median OS in the China cohort reached 25.3 months, extending nearly 11 months compared to the sorafenib group. Among existing landmark survival data for the Chinese population, the 3-year OS rate for patients from Hong Kong and Taiwan reached 49.2%. The approval of the STRIDE regimen marks that liver cancer treatment will now measure efficacy by ‘five-year or longer survival rates,’ leading the field into the era of dual immunotherapy and bringing significant hope for long-term survival to liver cancer patients in China.”
Dr. Jing He, Global Senior Vice President, Head of Global R&D China at AstraZeneca, stated: “The successful approval based on the HIMALAYA study represents a breakthrough achievement for AstraZeneca in the field of dual immunotherapy and brings substantial progress to the unmet needs of liver cancer patients. The results from the China cohort not only validate the clinically meaningful survival benefit of the STRIDE regimen in the Chinese population but also contribute crucial ‘China evidence’ to the global community. China has become one of the innovation hubs in AstraZeneca’s global R&D landscape, having designed and led multiple global clinical studies in areas such as gastrointestinal cancers. Moving forward, we will continue to leverage our R&D capabilities and extensive collaborations to accelerate the global reach of China’s innovative insights and clinical solutions, fulfilling our commitment to ‘In China, for China, benefiting the world.'”
Ms. Dongmei Guan, General Manager of AstraZeneca China Oncology Business, stated: “The approval based on the HIMALAYA study is another milestone in AstraZeneca’s deep commitment to the gastrointestinal cancer field, marking our official entry into the liver cancer arena. China has long faced a heavy burden of liver cancer. The STRIDE regimen, with its unique mechanism of action and dosing strategy, enhances efficacy while maintaining safety, offering an important new treatment option for Chinese patients with unresectable hepatocellular carcinoma and igniting hope for long-term survival. In the future, AstraZeneca will continue to collaborate with partners across the board, leveraging the power of science and innovation to accelerate diagnostic and therapeutic transformation, facilitate access to innovative therapies, and work together towards the ambitious goals of ‘Healthy China 2030.'”
About Liver Cancer
Liver cancer, of which HCC is the most common type, is the third leading cause of cancer death, with nearly 900,000 people diagnosed worldwide each year, and high incidence rates in some regions of Asia[11],[12]. 80-90% of HCC patients also have cirrhosis, primarily caused by hepatitis B virus or hepatitis C virus infection. Chronic liver disease is associated with inflammation and, over time, leads to immunosuppression and the development of HCC[13].
Advanced HCC has a poor prognosis, with a 5-year survival rate of only 7%[12]. More than half of patients are diagnosed at an advanced stage of the disease, which is often when symptoms first appear[14]. The unique immune environment of liver cancer provides a clear rationale for developing drugs that harness the power of the immune system to treat HCC[12].
About the HIMALAYA Study
The HIMALAYA study is a randomized, open-label, global multicenter Phase III clinical trial comparing durvalumab monotherapy and a regimen consisting of a single priming dose of 300 mg tremelimumab combined with 1500 mg durvalumab, followed by durvalumab administered every four weeks, against the standard of care, the multikinase inhibitor sorafenib monotherapy.
The study enrolled 1,324 adult patients with unresectable HCC who had not received prior systemic therapy and were not suitable for locoregional therapy (treatment confined to the liver and surrounding tissues).
The study was conducted at 190 centers across 16 countries, including the United States, Canada, Europe, South America, and Asia. The primary endpoint was OS for the combination regimen compared to sorafenib monotherapy. Key secondary endpoints included OS for durvalumab compared to sorafenib, objective response rate, and progression-free survival (PFS) for the combination regimen and durvalumab monotherapy.
The global HIMALAYA study included patients from Hong Kong and Taiwan, China (n=141). Additionally, an expansion cohort was conducted in Mainland China (n=180). Data from these two groups were pooled (China-related pooled analysis) and evaluated together. In this pooled cohort, there were 116 patients in the STRIDE regimen group, 106 in the durvalumab monotherapy group, and 99 in the sorafenib group.
About Durvalumab
Durvalumab is a human monoclonal antibody directed against PD-L1. It blocks the binding of PD-L1 to PD-1 and CD80, thereby countering tumor immune evasion strategies and restoring suppressed immune responses.
Based on overall survival (OS) data, durvalumab is a global standard of care for patients with Stage III unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following chemoradiotherapy. Additionally, durvalumab is approved in combination with neoadjuvant chemotherapy for the perioperative treatment of resectable NSCLC and in combination with a short course of tremelimumab and chemotherapy for the treatment of metastatic NSCLC. Durvalumab is also approved for the treatment of patients with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemoradiotherapy, and in combination with chemotherapy for the treatment of extensive-stage SCLC.
Durvalumab is also approved in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer, and in combination with tremelimumab for the treatment of unresectable HCC. In Japan and the European Union, durvalumab is also approved as monotherapy for the treatment of unresectable HCC. In the United States and the European Union, durvalumab is approved in the perioperative setting in combination with standard-of-care chemotherapy for the treatment of resectable gastric and gastroesophageal junction adenocarcinoma.
Perioperative treatment with durvalumab in combination with neoadjuvant chemotherapy has been approved for muscle-invasive bladder cancer [Note: This indication has not been approved in China]. In May 2025, results from the POTOMAC Phase III trial showed that durvalumab in combination with standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy met the primary endpoint of disease-free survival in patients with high-risk non-muscle-invasive bladder cancer.
Durvalumab is approved in combination with chemotherapy, followed by durvalumab monotherapy, for the first-line treatment of primary advanced or recurrent endometrial cancer (approved for mismatch repair deficient [dMMR] type in the US, EU, and China). In the EU and Japan, durvalumab is also approved in combination with chemotherapy, followed by durvalumab in combination with olaparib, for the treatment of patients with proficient mismatch repair (pMMR) advanced or recurrent endometrial cancer.
Since its first approval in May 2017, over 414,000 patients have been treated with durvalumab. As part of a broad development program, durvalumab is being explored as monotherapy or in combination with other anti-cancer agents for the treatment of NSCLC, SCLC, bladder cancer, breast cancer, ovarian cancer, and various gastrointestinal cancers.
About Tremelimumab
Tremelimumab is a human monoclonal antibody targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, helping to activate T cells and enhance the immune response against tumors, promoting cancer cell death. In addition to the approved indications for liver and lung cancers, tremelimumab is currently being investigated in combination with durvalumab across various tumor types, including HCC suitable for locoregional therapy (EMERALD-3), SCLC (ADRIATIC), NSCLC, and bladder cancer (VOLGA and NILE).
About AstraZeneca’s Research in Immuno-Oncology (IO)
AstraZeneca is a pioneer in introducing immunotherapy into areas of high unmet medical need, possessing a comprehensive and diverse IO portfolio and pipeline. Based on immunotherapy, the company aims to overcome anti-tumor immune evasion and stimulate the body’s immune system to attack tumors.
AstraZeneca aims to reshape cancer treatment through durvalumab monotherapy and in combination with tremelimumab or other innovative immunotherapies and mechanisms to help change outcomes for patients. The company is also exploring next-generation immunotherapies, such as bispecific antibodies, that leverage different aspects of immunity to target cancer, including cell therapies and T-cell engagers.
AstraZeneca is boldly pursuing innovative clinical strategies to introduce IO-based therapies across various tumor types, aiming to deliver long-term survival benefits. The company focuses on exploring novel combination therapies to help prevent resistance and promote more durable immune responses. With a rich clinical research program, the company also advocates for the use of immunotherapy earlier in the disease course, where the potential for cure is greatest.
About AstraZeneca’s Research in Gastrointestinal Cancers
AstraZeneca has a broad development program in the treatment of gastrointestinal cancers, encompassing multiple drugs across various tumor types and disease stages. In 2022, gastrointestinal cancers accounted for approximately 5 million new cases and about 3.3 million deaths[15].
Within this program, the company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic, and colorectal cancers.
In addition to the approved indications for BTC and HCC, the company is evaluating durvalumab in combination with tremelimumab for the treatment of liver, esophageal, and gastric cancers through a broad development program spanning from early to late-stage disease.
Enhertu is a HER2-targeting antibody-drug conjugate approved in the US and several other countries for the treatment of advanced HER2-positive gastric cancer and is being evaluated for its potential in the first-line setting. Enhertu is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
Lynparza is a first-in-class PARP inhibitor approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is jointly developed and commercialized by AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada).
The company is also evaluating the PD-1/TIGIT bispecific antibody rilvegostomig (AZD2936) in combination with chemotherapy as adjuvant therapy for BTC, in combination with bevacizumab with or without tremelimumab for first-line HCC, and for first-line treatment of HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Rilvegostomig is also being evaluated in combination with Enhertu for the first-line treatment of patients with locally advanced or metastatic HER2-expressing BTC.
AstraZeneca is advancing multiple therapeutic modalities to provide complementary mechanisms for targeting Claudin 18.2, a promising target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class Claudin 18.2-targeting ADC under a license agreement with KYM Biosciences Inc. (KYM), currently in Phase III clinical development; AZD5863, a novel Claudin 18.2/CD3 T-cell engaging bispecific antibody under a license agreement with Harbour BioMed, currently in Phase I clinical development; and AZD4360, an antibody-drug conjugate currently being evaluated in a Phase I/II trial in patients with advanced solid tumors.
In early development, AstraZeneca is developing two Glypican 3 (GPC3) armored CAR-T therapies for HCC. AZD5851 is in Phase I development globally, and C-CAR031/AZD7003 is being co-developed in China in collaboration with Cellular Biomedicine Group (CBMG) and is being evaluated in an investigator-initiated trial (IIT).
About AstraZeneca in Oncology
AstraZeneca is leading a revolution in oncology, committed to providing a diverse portfolio of cancer treatments, using science to explore the complexity of cancer, and discovering, developing, and delivering life-changing medicines to patients.
AstraZeneca focuses on some of the most challenging cancers. Through persistent innovation, the company has built one of the industry’s most diverse portfolios and pipelines, driving medical practice change and transforming the patient experience.
AstraZeneca aims to redefine cancer care and, one day, eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca (LSE/STO//NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com.
Disclaimer: This statement involves products or indications not yet approved in China. AstraZeneca does not recommend any use of unapproved drugs.
*As of April 27, 2026, it is the only one.
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