The hepatocellular carcinoma (HCC) pipeline is highly active and evolving, and while Bayer’s and Merck/Eisai’s respective tyrosine kinase inhibitors Nexavar (sorafenib) and Lenvima (lenvatinib) are likely to dominate in the next few years, they will lose market share after 2020 in the eight major markets (8MM*) due to the emergence of checkpoint inhibitors, according to GlobalData, a leading data and analytics company.
The company’s latest report: Hepatocellular Carcinoma: Competitive Landscape to 2026, states that combinations of anti-PD1 or -PDL1 antibodies with kinase inhibitors, CTLA4 inhibitors, or VEGF inhibitors are set to launch across the 8MM starting from 2021.
Francesca Blum, MSci, UK Oncology Director at GlobalData, says: “Bristol-Myers Squibb’s Opdivo (nivolumab) is set to become the first checkpoint inhibitor approved in first-line HCC in the US, while Eli Lilly’s Cyramza (ramucirumab) is expected to be the first VEGF inhibitor approved for HCC treatment.
“Novel kinase inhibitors are also entering the market, including Exelixis/Ipsen’s kinase inhibitor Cabometyx (cabozantinib), which was recently approved in the EU in November 2018 for second-line HCC, and the FDA is expected to make a decision regarding its approval in the US by January 2019. It is set to compete with Bayer’s Stivarga (regorafenib).”
The HCC pipeline features 319 products across all stages of clinical development, and the early stage pipeline is dominated by small molecules, but also includes monoclonal antibodies, vaccines, and gene therapies.
Blum continues: “More than 45% of the drugs currently in early stage development are small molecules, reflecting the current focus among drug developers for this indication. In addition, immuno-oncology (IO) drugs comprise around 50% of the pipeline overall, and most of which are in early stages of development.
“The early stage pipeline includes around 100 IO products, including eight chimeric antigen receptor T-cell therapies, two of which are in Phase I, while the others are still in preclinical development. There are also 24 pipeline IO drugs which act on immune checkpoint proteins.”
GlobalData’s report also found that several developers, notably Exelixis, Ipsen and MedImmune, have strong pipelines in HCC.
Blum concludes: “While Bayer currently leads the market with Nexavar and Stivarga, it lacks novel therapies in its late-stage pipeline, which will leave room for other players like Eisai and Merck, and others with pipeline therapies, to carve out a share of this increasingly competitive market.”
*8MM = US, France, Germany, Italy, Spain, UK, Japan, and China