A checkpoint inhibitor under development by China’s Junshi Biosciences and Coherus BioSciences hit the mark in a Phase III lung cancer study.
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A checkpoint inhibitor under development by China’s Junshi Biosciences and Coherus BioSciences hit the mark in a Phase III lung cancer study. The companies announced that toripalimab plus chemotherapy met both primary endpoints of progression-free survival and the prespecified secondary endpoint of overall survival compared to chemotherapy alone.
Data from the Phase III CHOISE-01 trial studying toripalimab plus chemotherapy as a first-line treatment for advanced squamous or non-squamous non-small cell lung cancer showed the combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival. Median progression-free survival was 8.4 months compared to 5.6 months for placebo. The companies noted that one-year PFS rates were 36.7% for toripalimab plus chemotherapy compares to 17.2% for placebo.
The CHOICE-01 study also showed an improvement in overall survival in in a prespecified interim analysis, the companies said. Results from the study are expected to be summarized later today during a presentation during the ASCO Plenary Series.
Toripalimab is an anti-PD-1 monoclonal antibody that has been developed for its ability to block PD-1 interactions with PD-L1 and PD-L2, as well as for enhanced receptor internalization. The two companies said that blocking PD-1 interactions with the PD-L1 and PD-L2 ligands promotes the immune system’s ability to attack and kill tumor cells.
Theresa LaVallee, chief development officer at Coherus BioSciences, said that in the CHOICE-01 study. Toripalimab has “once again demonstrated the potential to delay disease progression” and help patients with non-small cell lung cancer live longer.
“The study investigators also reported interesting biomarker data with toripalimab plus chemotherapy having activity independent of PD-L1 expression as well as a statistically significant overall survival advantage in NSCLC patients who have alterations in the focal adhesion-PI3K-AKT signaling pathway, a finding which may inform the design of future toripalimab clinical trials,” LaVallee said in a statement.
Patricia Keegan, chief medical officer of Junshi Biosciences, expressed her excitement regarding the “consistently strong clinical evidence” the companies have seen with toripalimab across multiple tumor types.
“The addition of toripalimab to chemotherapy in patients with advanced NSCLC provided superior PFS and OS compared to chemotherapy alone with a manageable safety profile. These results support the use of toripalimab with chemotherapy as first-line therapy for advanced NSCLC patients without EGFR/ALK mutations,” Keegan said in a statement.
The two companies have filed for approval of toripalimab in advanced squamous or non-squamous non-small cell lung cancer in China, where it has previously been approved for use in four different indications. Those indications are metastatic melanoma, metastatic nasopharyngeal carcinoma (NPC), metastatic urothelial carcinoma and as the first-line treatment for locally recurrent or metastatic NPC. In China, the drug is marketed as Tuoyi.
Based on data from the CHOICE-01 study, the two companies are evaluating potential registration avenues for toripalimab as a first-line treatment of advanced non-small cell lung cancer in the United States.
In the United States, toripalimab has been granted priority review by the U.S. Food and Drug Administration for the treatment of recurrent or metastatic NPC. A PDUFA date has been scheduled for April of this year. It has also been granted Fast Track designation for the treatment of mucosal melanoma and orphan drug designation for the treatment of esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma.
