Nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell cancer involving the nasopharynx, accounts for almost 123,000 new incident cases each year worldwide. Most cases are of recurrent or metastatic nature, presenting with poor prognoses. The current standard of care for recurrent or metastatic NPC remains platinum-based chemotherapy, mainly gemcitabine + cisplatin with a median progression-free survival (PFS) of seven months.
AiRuiKa (camrelizumab) is a programmed cell death ligand 1 (PD-L1) inhibitor being developed by Jiangsu HengRui Medicine, a Chinese pharmaceutical company. The drug is one of the key pipeline agents targeting this group of NPC tumours characterised by high PD-L1 expression. CAPTAIN-1st, a multicentre, randomised, double-blind, Phase III trial, assessed the use of camrelizumab in combination with gemcitabine + cisplatin in the first-line setting. On statistical analysis of Phase III results presented at this year’s virtual Annual American Society of Clinical Oncology conference (ASCO 2021) on 4–8 June, the camrelizumab arm demonstrated a median PFS of 10.8 months as compared to the placebo + chemotherapy arm’s median PFS of 6.9 months, and had a 49% lower risk of disease progression or death.
Safety analysis revealed the frequency and grade of treatment-related adverse events to be comparable between the treatment groups. Popular key opinion leader (KOL) opinion has been that the addition of immunotherapy to existing chemotherapy adds survival benefits, and therefore this target patient population has seen the use of Keytruda (pembrolizumab), despite being excluded from the pivotal trial KEYNOTE-048. This addition of immunotherapy to chemotherapy would be the first label to be sought for use in first-line NPC.
We can expect Jiangsu HengRui Medicine to submit data to China’s National Medical Products Administration (NMPA) for approvals, as well as seeking approvals in the US, followed by market launches in China in 2023 and the US in 2024. These wins will help solidify AiRuika’s position in global markets, where it is anticipated to satisfy major unmet needs in head and neck cancer for therapies with superior efficacy and overall survival. We can, overall, expect that Chinese checkpoint inhibitors will considerably drive down prices for existing brands and increase drug competition in the head and neck cancer space.