AstraZeneca Pharma India Ltd. (AZPIL), a global, science-led biopharmaceutical company, has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Durvalumab solution for infusion (120 mg/2.4 mL and 500 mg/10 mL) for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.
Worldwide, hepatocellular carcinoma (HCC) is the sixth most common cancer and the third leading cause of cancer-related death. In India, according to GLOBOCAN 2022, more than 38,000 new cases of HCC are diagnosed annually, making it the 11th most common cancer. HCC’s high mortality rate makes it the 8th leading cause of cancer-related deaths in the country, underscoring the urgent need for effective treatment options for patients who often present at an advanced, unresectable stage.
Durvalumab in combination with a single dose of tremelimumab (STRIDE regimen) has previously been approved in patients with uHCC based on the HIMALAYA global Phase III trial, in which the combination demonstrated superior outcomes over sorafenib. While immunotherapy combinations and anti‑VEGF tyrosine kinase inhibitors have expanded the treatment landscape for unresectable HCC, an estimated 25–30% of patients are not eligible for these regimens due to comorbidities, contraindications or treatment tolerability concerns. In the HIMALAYA trial, durvalumab monotherapy achieved non‑inferior overall survival versus sorafenib and demonstrated a favourable benefit–risk profile, providing an important option for patients with uHCC who have not received prior systemic therapy.
“The durvalumab monotherapy approval offers a new treatment option and brings renewed hope for long-term survivorship with immunotherapy for patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy,” said Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited. “However, the unmet need remains significant, too many patients are diagnosed late, face limited options, and require treatments that can extend life with good quality. At AstraZeneca, our purpose is to transform patient outcomes and leave no patient behind. This approval advances that ambition by bringing proven science to all patients sooner. Our commitment is to accelerate access responsibly, partner across the health system to reduce barriers, and improve both the length and quality of life for all patients.”
The approved regimen, referred to as the durvalumab monotherapy regimen, comprises a fixed dose of single-agent Durvalumab, an anti–PD‑L1 immunotherapy, 1500 mg administered every four weeks until disease progression or unacceptable toxicity. This simplified, fixed-dose schedule is designed to support consistent delivery of treatment and may help reduce the burden of frequent hospital visits for eligible patients and their caregivers.
The CDSCO decision is supported by results from the HIMALAYA Phase III trial, in which durvalumab monotherapy met its primary objective of demonstrating non‑inferior overall survival compared with sorafenib in patients with unresectable HCC who had not received prior systemic therapy and were not amenable to locoregional treatment. The favourable benefit–risk profile observed in this population reinforces the role of durvalumab monotherapy as an important option, particularly for patients who may not be suitable for combination immunotherapy or anti‑VEGF–based regimens.
References:
· National Cancer Institute – Liver Cancer: Causes and Risk Factors
· GLOBOCAN 2022 India
· Ghassan K Abou-Alfa et al. NEJM Evid 2022; 1(8) | DOI: 10.1056/EVIDoa2100070
