A pre-specified interim analysis of Junshi Biosciences’ Phase III Neotorch trial showed its anti-PD-1 monoclonal antibody, toripalimab, met its primary endpoint in non-small cell lung cancer (NSCLC).
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A pre-specified interim analysis of Junshi Biosciences’ Phase III Neotorch trial showed the anti-PD-1 monoclonal antibody, toripalimab, met its primary endpoint in non-small cell lung cancer (NSCLC), the Chinese biotech announced Wednesday.
According to the interim analysis, toripalimab combined with platinum-containing doublet chemotherapy may significantly extend event-free survival (EFS) among NSCLC patients, compared to chemotherapy alone.
The investigational treatment was also safe with a risk profile consistent with what had already been established, and no new safety signals arose in Neotorch. Junshi stated it is seeking a supplemental New Drug Application for toripalimab in the near future and will engage regulatory bodies toward this end.
Toripalimab is a monoclonal antibody targeting the PD-1 receptor protein, blocking its interactions with its ligands PD-L1 and PD-L2. In turn, this boosts the immune system’s ability to seek and destroy cancer cells. Junshi’s candidate also enhances the internalization of the receptor.
Currently, the FDA is reviewing Junshi’s Biologics License Application for the candidate as a combination therapy with gemcitabine and cisplatin in patients with advanced recurrent or metastatic nasopharyngeal carcinoma. The agency is also reviewing toripalimab as a monotherapy for recurrent or metastatic nasopharyngeal carcinoma in later lines of treatment.
The FDA has also granted toripalimab Breakthrough Therapy designation for recurrent or metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma and Orphan Drug designation for esophageal cancer, nasopharyngeal cancer, mucosal melanoma, small cell lung cancer and soft tissue sarcoma.
A U.S.-Registered Chinese Trial?
Neotorch is the world’s first registered Phase III immuno-oncology trial for lung cancer to post positive EFS data.
Aside from EFS, the study also looked at the major pathological remission rate as its primary efficacy measure.
The trial is registered in the U.S. but is a predominantly Chinese study, involving 56 centers across mainland China. While not completely unheard of, this is unusual, especially because Junshi plans to seek U.S. approval for toripalimab in this indication.
Junshi may also need to conduct a separate clinical trial in the U.S. In February of 2022, the FDA’s Oncologic Drugs Advisory Committee voted 14 to 1 that Eli Lilly and its Chinese partner Innovent Biologics would need to run a U.S. trial for its PD-1 inhibitor sintilimab.
The drug is approved in China, where it is marketed as Tyvyt, for the first-line treatment of stage IIIB and IIIC or stage IV NSCLC in adult patients. Data from the ORIENT-11 trial, which was conducted completely in China, supported its approval.
In a statement at the time, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, stated, “Single country submission is a step backward in achieving the racial diversity that we need in the United States.”
