View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
August 19, 2021

Coherus-Junshi’s toripalimab meets primary goal in Phase III NSCLC trial 

The antibody offered statistically significant and clinically meaningful improvement in progression-free survival in NSCLC patients.

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy