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Dec, 14 2022

FDA Approves Tremelimumab in Combination with Durvalumab for Unresectable Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related deaths in the world. Patients suffering from very early-stage and early-stage disease (20%-30% of HCC patients) are appropriate for curative treatments, such as resection, liver transplantation, local ablation with percutaneous ethanol injection, or radiofrequency ablation (RFA). Patients having advanced-stage HCC with macroscopic vascular invasion, extrahepatic spread, or cancer-related symptoms (performance status 1-2) may have a slight improvement in prognosis from first-line treatment with sorafenib, which is a molecularly targeted drug, while patients with end-stage disease (10%-20% of HCC patients) receive only symptomatic treatment. With respect to the hepatocellular carcinoma, the Barcelona clinic liver cancer classification is the current standard classification system for the management of patients suffering from HCC and suggests that patients with intermediate-stage HCC benefit from transcatheter arterial chemoembolization (TACE). The involvement of several interventional treatments such as drug-eluting bead embolization, TACE, balloon-occluded TACE, radioembolization, and combined therapies such as TACE and radiofrequency ablation, continue to evolve leading to improved patient prognosis.

Our DBMR team investigated the global hepatocellular carcinoma drugs market and witnessed that the market is rising gradually with the steady CAGR of 3.9% in the forecast period of 2023-2029. It has also been mentioned that the incidence of HCC is more in Asia and Africa, as compared to Africa and Asia, the incidence of HCC is highest in Asia, with incidence rates in men of 35 per 100,000 populations.

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Most patients receive palliative or conservative therapy only, and around 50% of patients with HCC are candidates for systemic therapy. But, these patients require therapy that is more effective than sorafenib or conservative treatment. Numerous researchers try to perform more effective therapies, such as combined therapies (TACE with radiotherapy and sorafenib with TACE), modified TACE for HCC with arterioportal or arteriohepatic vein shunts, TACE based on hepatic hemodynamics, and isolated hepatic perfusion.

Line of Treatments for Different Stages of HCC

  • Patients suffering from intermediate stage HCC, transarterial intervention, predominantly TACE, is the most recommended BCLC classification treatment and is approved by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases guidelines.
  • Patients suffering from advanced stage HCC, first-line of treatment with sorafenib is recommended for this stage of HCC. This statement is based on the BCLC treatment algorithm and on the results of multiple randomized trials in Europe and Asia associated with sorafenib. Though, overall survival was only modestly improved by 2.8 months. Sorafenib is an antiangiogenic drug which blocks tumor cell proliferation and angiogenesis by restricting the activity of VEGF receptors. Combining sorafenib with TACE may potentially improve the treatment outcome. Patients having advanced-stage HCC require more effective therapy than sorafenib or other conservative treatment, and this is under consideration.

Our DBMR team has investigated the angiogenesis inhibitors market and witnessed that North America dominates the market due to the growing incidence of cancer in the country, the presence of key market players, and the launch of new commodities influence market growth in this region. On the other hand, Asia-Pacific has the highest growth due to the factors such as the surging awareness about early diagnosis, growth in healthcare expenditure, high unmet clinical needs of patients as well as the effective treatment in emerging countries such as China and India in the region.

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A recent study has been performed on the combinational therapy of tremelimumab and durvalumab for adult patients with unresectable hepatocellular carcinoma (HCC). This is a randomized, open-label, multi-center, global, Phase III study to evaluate the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. This approval is based on a comparison of the 782 patients randomized to tremelimumab plus durvalumab to sorafenib. Patients eligible for this study were above 18 years old.

Patients were randomized to one of following three arms:

  • Tremelimumab 300 mg as a one-time single intravenous (i.v.) infusion plus durvalumab 1500 mg i.v. on the same day, followed by durvalumab 1500 mg i.v. every 4 weeks
  • Durvalumab 1500 mg i.v. every 4 weeks
  • Sorafenib 400 mg orally twice daily until disease progression or unacceptable toxicity




Overall Survival (OS)

Time to Progression (TTP)


Progression-free survival (PFS)


Objective response rate (ORR)


Disease control rate (DCR)


Duration of response (DoR)

The efficacy outcomes were then calculated and the result was very much in favor of the combination of Tremelimumab plus durvalumab. Tremelimumab plus durvalumab revealed a statistically significant and clinically meaningful improvement in OS compared to sorafenib and the median OS was 16.4 months versus 13.8 months. Median PFS was 3.8 months and 4.1 months for the tremelimumab plus durvalumab and sorafenib arms, respectively. ORR was 20.1% in the tremelimumab plus durvalumab arm and 5.1% for those treated with sorafenib.

There were some adverse reaction noticed which were rash, diarrhoea, fatigue, pruritis, musculoskeletal pain and abdominal pain in around more than 20% of patients. The recommended tremelimumab dose for patients weighing 30 kg or more is 300 mg i.v. as a single dose in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab 1500 mg i.v. every 4 weeks. For those weighing less than 30 kg, the recommended tremelimumab dose is 4 mg/kg i.v. as a single dose in combination with durvalumab 20 mg/kg i.v., followed by durvalumab 20 mg/kg i.v. every 4 weeks.


Unresectable HCC generally represents as a hypervascular tumor. TACE induces a post-treatment surge of angiogenic factors, such as vascular endothelial growth factor (VEGF) that can occur as early as a few hours post-TACE. Additionally, Sorafenib is an antiangiogenic drug which blocks tumor cell proliferation and angiogenesis by inhibiting the activity of VEGF receptors. This study clearly showed that combining tremelimumab and durvalumab can actually help in increasing the survival rate of HCC patients. Thus, numerous studies have evaluated the efficacy and safety of this combination treatment.

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