Following the significant effects of the 'dual immunotherapy', the new combination treatment has been approved from the FDA, EMA and NMPA for previously untreated advanced HCC patients. The research team includes (from left) Professor Cheung Tan-to, Dr Thomas Yau Chung-cheung and Dr Ronald Leung Ching-yu.
A research team from the School of Clinical Medicine of the LKS Faculty of Medicine of the University of Hong Kong (HKUMed) has pioneered the use of a 'dual immunotherapy' combination—nivolumab and ipilimumab (NIVO+IPI) — in the treatment of liver cancer patients since 2016. This innovative treatment has proved to significantly improve survival rates and tumour control compared to current first-line treatments, lenvatinib and sorafenib. Recently it was approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and China's National Medical Products Administration (NMPA) for global use, offering new hope to liver cancer patients worldwide. This landmark study was published in The Lancet [link to the publication].
Liver cancer is the sixth most common cancer worldwide and the third leading cause of cancer mortality. In Hong Kong, it ranks fifth in annual cancer incidence and third in mortality. Hepatocellular carcinoma (HCC), the most common type of primary liver cancer, accounts for 90% of all liver cancer cases and is often diagnosed at an advanced stage. Treatment options are limited due to significant drug resistance, tumour diversity, and the absence of easily targetable mutations. 'Patients with advanced HCC typically survive less than a year without treatment,' stated Dr Thomas Yau Chung-cheung, Clinical Associate Professor in the Centre of Cancer Medicine and Department of Medicine, School of Clinical Medicine, HKUMed, who led this global study.
Since 2016, the research team has led multinational trials to evaluate the preliminary efficacy and safety of using a dual immunotherapy combination of NIVO (a PD-1 inhibitor) + IPI (a CTLA-4 inhibitor). Both drugs are immune checkpoint inhibitors that help the immune system recognise and attack cancer cells. Nivolumab blocks PD-1, a protein that prevents immune cells from targeting tumours, while ipilimumab boosts the immune system by blocking CTLA-4, another immune checkpoint protein.
'The latest Phase 3 trials were conducted from 2020 to 2021 across 25 countries and regions to confirm the survival benefits of the NIVO+IPI combination and assess whether the combination could outperform traditional therapies,' Dr Yau explained. The study enrolled 668 patients with advanced HCC who had not previously received systemic therapy.
The results indicated that patients treated with the new NIVO+IPI combination demonstrated longer survival and a reduction in disease progression. The median survival time was 23.7 months, compared to 20.6 months for those receiving traditional treatments (lenvatinib or sorafenib). Remarkably, at the 36-month mark, 38% of patients on the new combination therapy were still alive, compared to 24% of those on existing treatments. Around 70% of the patients had satisfactory tumour control and derived clinical benefits. The new combination therapy achieved a 36% response rate in shrinking or eliminating tumours, nearly three times the 13% observed with traditional treatments. Additionally, the responses were significantly more durable, lasting an average of 30.4 months, compared to just 12.9 months with traditional treatments.
'Our new combination treatment offers unprecedented potential for survival benefits, durable tumour control, and enhanced quality of life,' highlighted Dr Yau. 'This milestone reflects the efficacy of our research and opens doors for patients worldwide to benefit from this innovative therapy. Given its significant effects, the NIVO+IPI combination treatment has received approval from the FDA, EMA and NMPA for previously untreated advanced HCC patients.'
About the Research Team
The study was led by Dr Thomas Yau Chung-cheung, Clinical Associate Professor in the Centre of Cancer Medicine and the Department of Medicine, School of Clinical Medicine, HKUMed.
Acknowledgments
This research was funded by Bristol-Myers Squibb.
