NSCLC Drug Improves Progression-Free Survival in Late-Stage Trial

 

Chinese pharmaceutical company Junshi Biosciences has announced that the Phase III clinical trial it is conducting alongside California-based Coherus BioSciences on a potential non-small cell lung cancer (NSCLC) drug is showing positive preliminary results. 

The CHOICE-01 trial, a randomized, double-blind, placebo-controlled study, evaluates the effectiveness of combining toripalimab with chemotherapy as first-line treatment of advanced squamous or non-squamous NSCLC. 

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization. Blocking interactions with the ligands is believed to boost the immune system’s ability to attack and eliminate tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (as the brand TUOYI). 

According to its statement, the interim results showed that the study met its primary endpoint of showing clinically significant improvement in progression-free survival (PFS) compared to just using chemotherapy. The PFS was measured according to RECIST v1.1, the standard measurement method to determine how well a patient responds to their treatments. 

“The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer,” said Ildiko Csiki, M.D., Ph.D., the chairperson for the Coherus Scientific Advisory Board and chief commercial research and development officer at cancer center City of Hope.

Dr. Csiki added that toripalimab appears to be showing itself as an excellent checkpoint inhibitor. His team is also eagerly awaiting more results from its ongoing Phase III study for its potentially positive effects on breast, liver, lung, esophageal, bladder, stomach, kidney, and skin cancers. 

Source: BioSpace

The CHOICE-01 trial studies 465 treatment-naive advanced NSCLC patients, 245 of whom have non-squamous cancer while the other 220 have squamous cancer. Of this total, 309 were given toripalimab and chemotherapy, and 15 were given a placebo plus chemotherapy. The primary endpoint is PFS, while the secondary endpoints include overall survival (OS), objective response rate (ORR), and duration of response (DoR). 

“With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets,” noted Dr. Patricia Keegan, chief medical officer at Junshi Biosciences, in the same press release.

The results of the study will be summarized on September 13, 2021 at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.

 

BioSpace source:

https://www.biospace.com/article/non-small-cell-lung-cancer-drug-trial-shows-positive-results-says-junishi-coherus-biosciences