The overall level of unmet need in hepatocellular carcinoma (HCC) is high due to its severity and low survival. However, the needs will soon be relatively well met, as many new liver cancer therapies entering the market have different mechanisms of action and are aiming to meet needs in different treatment settings, says GlobalData after reviewing the market and talking to key opinion leaders (KOLs) in the field.
According to the data and analytics company, the variety of pipeline products in the adjuvant setting (Barcelona clinic liver cancer [BCLC] Stage A), intermediate (BCLC Stage B), and advanced (BCLC Stages B and C) stages bring hope for improvements to the cure rate for early-stage disease and survival in all stages over the currently marketed therapies.
The five key unmet needs and opportunities in the HCC market are as follows: better HCC surveillance and prophylactic treatments, curative therapies in early-stage HCC, improved survival for intermediate-stage HCC, predictive biomarkers, and treatments for patients with impaired liver function.
KOLs interviewed by GlobalData noted that better HCC surveillance and prophylactic treatments are highly desirable since a delay in diagnosis puts the patient at risk for diagnosis of a higher BCLC stage, where they may be deemed ineligible for curative treatment options.
“While other oncology indications experienced improved cure rates from adjuvant therapy, there are currently no adjuvant therapies available for HCC patients,” said Mandana Emamzadeh, a pharma analyst at GlobalData. “Current studies are investigating immuno-oncology (IO) agents alone or in combination with Avastin after ablation or resection as an adjuvant therapy, which is intended to reduce the recurrence rate of HCC.”
Furthermore, the pipeline products in the intermediate setting are aiming to combine IO agents, tyrosine kinase inhibitors, and angiogenesis inhibitors with transarterial chemoembolization (TACE). KOLs revealed that combining systemic therapies with TACE might improve TACE’s efficacy in comparison with TACE alone, but the exacerbated adverse effects should not be overlooked.
In addition, more studies are required to evaluate the safety and efficacy of systemic therapy versus TACE and to investigate the replacement of TACE with the advanced HCC treatments for most, if not all, intermediate patients.
“A large number of pipeline agents with innovative approaches are under investigation for adjuvant, intermediate, and advanced therapy,” Emamzadeh noted. “However, KOLs asserted that the assignment of patients to a suitable therapy is not feasible with current methods. Therefore, new biomarkers are urgently needed to select the most appropriate treatment for each individual HCC patient. GlobalData anticipates that the opportunities will remain for further biomarkers to predict high responders.”