Shanghai Junshi Biosciences and Coherus BioSciences have reported positive interim data from the Phase III CHOICE-01 clinical trial of toripalimab plus chemotherapy as first-line therapy for advanced squamous or non-squamous non-small cell lung cancer (NSCLC).
An anti-programmed cell death protein 1 (PD-1) monoclonal antibody, toripalimab can restrict PD-1 interactions with its PD-L1 and PD-L2 ligands and boost receptor internalisation or endocytosis function.
The randomised, double-blind, placebo-controlled CHOICE-01 trial enrolled a total of 465 treatment-naive advanced NSCLC patients.
The subjects were randomised in a 2:1 ratio to receive toripalimab plus chemotherapy or placebo plus chemotherapy.
Results showed that the interim analysis met the primary goal, showing a statistically significant and clinically meaningful enhancement in progression-free survival (PFS) versus chemotherapy alone.
As of interim analysis data cut-off date of 17 November 2020, 218 PFS events were noted with a median follow up of 7.1 and seven months in the toripalimab group and the control group, respectively.
Furthermore, the one-year PFS rates were 32.6% and 13.1%, respectively, for the toripalimab and control groups.
This PFS improvement was reported in squamous and non-squamous NSCLC, which was irrespective of PD-L1 expression.
In squamous NSCLC subjects, toripalimab plus chemotherapy offered an objective response rate (ORR) of 68.7% and 58.9% in the control arm as against 58.6% and 26.5% in the non-squamous NSCLC subjects.
A trend of overall survival favouring the toripalimab arm was noted even though the data were not mature as of 7 March this year.
Toripalimab plus chemotherapy treatment had a manageable safety profile without any new safety signal noted in advanced NSCLC patients.
In the toripalimab arm, the occurrence of Grade ≥3 adverse events (AEs) was 76.3% as against 80.1% in the control group.
Junshi Biosciences chief medical officer Dr Patricia Keegan said: “The CHOICE-01 study in patients with advanced non-small-cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and oesophagal squamous cell carcinoma.
“With an excellent clinical profile being established across multiple tumour types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets.”
Junshi and Coherus intend to hold discussions with the US Food and Drug Administration (FDA) on a potential biologics license application (BLA) for toripalimab as first-line therapy for advanced NSCLC.