In 2023, AstraZeneca announced a significant breakthrough in the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. The results from the EMERALD-1 Phase III trial demonstrated the effectiveness of AstraZeneca’s Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab. This combination therapy showcased a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) when compared to TACE alone for patients eligible for embolization. The trial is ongoing, focusing on the secondary endpoint of overall survival (OS).

Liver cancer, particularly HCC, remains a major global health concern, ranking as the third-leading cause of cancer-related mortality, with around 900,000 new diagnoses reported annually. Roughly 20-30% of HCC patients are eligible for embolization, a procedure that blocks the blood supply to the tumor while simultaneously delivering chemotherapy or radiation therapy directly to the liver. Despite being the standard of care in this setting, the majority of patients who undergo embolization experience rapid disease progression or recurrence.

Dr. Riccardo Lencioni, the principal investigator in the EMERALD-1 trial and a Professor and Director of the Cancer Imaging Program at Pisa University Hospital in Italy, emphasized the high rates of progression and recurrence experienced by HCC patients eligible for embolization. He underlined the potential of the durvalumab plus bevacizumab combination to significantly improve progression-free survival, offering new hope in the treatment of this complex and often poorly prognosed disease.

AstraZeneca’s Executive Vice President for Oncology R&D, Susan Galbraith, expressed her optimism about bringing this innovative treatment to patients with earlier stages of liver cancer. She highlighted the significance of these positive results and emphasized the importance of observing the survival data as it matures over time.

The safety profiles for Imfinzi, TACE, and bevacizumab were consistent with their known profiles, with no new safety findings. The data from the trial will be presented at a forthcoming medical meeting and shared with regulatory authorities.

AstraZeneca’s Commitment to GI Cancer Research

AstraZeneca’s commitment to advancing gastrointestinal (GI) cancer research extends beyond HCC. The company is actively engaged in a comprehensive clinical development program evaluating Imfinzi across multiple GI cancer settings.

In the EMERALD-2 trial, Imfinzi is being studied in combination with bevacizumab for adjuvant HCC. In the EMERALD-3 trial, Imfinzi is being assessed in combination with Imjudo (tremelimumab), lenvatinib, and TACE for embolization-eligible HCC.

The broader context of liver cancer reveals its significant global impact. It ranks as the third-leading cause of cancer-related death and the sixth most commonly diagnosed cancer worldwide. Notably, Asia accounts for over 70% of new liver cancer cases, highlighting the geographical variance in the prevalence of the disease. Approximately 75% of all primary liver cancers in adults are classified as HCC. Additionally, between 80-90% of HCC patients also suffer from cirrhosis, emphasizing the complex relationship between chronic liver diseases and HCC development. While immunotherapy has demonstrated its effectiveness in HCC treatment, approved options have been primarily available for patients in later-line settings.

The EMERALD-1 Trial

The EMERALD-1 trial represented a crucial milestone in the development of Imfinzi as a treatment for HCC. It was a randomized, double-blind, placebo-controlled, multicenter, global Phase III trial conducted in 157 centers across 18 countries. The trial enrolled a total of 616 patients with unresectable HCC who were eligible for embolization.

The primary endpoint of the trial was PFS for Imfinzi in combination with TACE and bevacizumab compared to TACE alone. Secondary endpoints included PFS for Imfinzi in combination with TACE, overall survival, patient-reported outcomes, and objective response rate.

Imfinzi’s Mechanism of Action

Imfinzi, also known as durvalumab, is a human monoclonal antibody designed to bind to the PD-L1 protein. This binding blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, effectively countering the tumor’s immune-evasion mechanisms and releasing the inhibition of immune responses.

Imfinzi has received approvals for various indications in gastrointestinal cancers. These include its use in combination with chemotherapy for locally advanced or metastatic biliary tract cancer and in combination with Imjudo for unresectable HCC. These approvals were based on the positive outcomes of the TOPAZ-1 and HIMALAYA Phase III trials, respectively.

Imfinzi also stands as the global standard of care in the curative-intent treatment of unresectable, Stage III non-small cell lung cancer (NSCLC) following chemoradiation therapy, supported by the PACIFIC Phase III trial.

Moreover, Imfinzi has secured approval for the treatment of extensive-stage small-cell lung cancer (SCLC) when combined with chemotherapy, and for previously treated advanced bladder cancer in select regions.

AstraZeneca’s Immuno-Oncology Initiatives

AstraZeneca has been at the forefront of immuno-oncology (IO), introducing the concept of immunotherapy to address high unmet medical needs. The company maintains a comprehensive and diverse IO portfolio and pipeline, with a focus on therapies designed to overcome tumor immune-evasion mechanisms and stimulate the body’s immune system to combat cancer.

AstraZeneca’s ambitions in IO extend to redefining cancer care and striving for long-term survival for patients, either through Imfinzi as a single treatment or in combination with Imjudo and other novel immunotherapies and modalities. The company explores next-generation immunotherapies, such as bispecific antibodies and treatments harnessing various aspects of immunity to target cancer.

AstraZeneca is committed to reimagining cancer care and hopes to eliminate cancer as a leading cause of death by pursuing an innovative clinical strategy that extends IO-based therapies to new settings across various cancer types. The company also advocates the use of IO treatments in earlier disease stages, where the potential for a cure is most significant.

AstraZeneca’s Oncology Vision

AstraZeneca has embarked on a revolutionary journey in the field of oncology with a vision to provide cures for cancer in all its forms. By rigorously following scientific developments and understanding the complexities of cancer, AstraZeneca is dedicated to discovering, developing, and delivering life-changing medicines to patients.

The company’s focus remains on the most challenging cancer types, working tirelessly to build one of the most diverse portfolios and pipelines in the industry. AstraZeneca aims to catalyze transformations in the practice of medicine and enhance the patient experience.

In the realm of gastrointestinal cancers, AstraZeneca is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic, and colorectal cancers. The company actively explores various medicines and treatment approaches across multiple disease stages, ranging from early to late-stage disease.

AstraZeneca is also conducting clinical trials to evaluate Imfinzi in resectable gastric and gastroesophageal junction cancers (MATTERHORN) and in locally advanced esophageal cancer (KUNLUN). In a promising development, Imfinzi, in combination with standard-of-care neoadjuvant chemotherapy, achieved a key secondary endpoint of pathologic complete response in the MATTERHORN Phase III trial in June 2023.

AstraZeneca’s dedication to oncology and immuno-oncology continues to drive scientific innovation and transformative solutions for cancer patients worldwide. The progress made in 2023, particularly in the EMERALD-1 trial, demonstrates the company’s unwavering commitment to advancing cancer care and improving the lives of those affected by this devastating disease.

38 thoughts on “AstraZeneca’s Imfinzi Triumphs in Phase III Trial for Liver Cancer in 2023”
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