Junshi plans filings after toripalimab hits target in upper throat cancer
China’s Junshi Biosciences has said it plans filings for a new cancer immunotherapy after its toripalimab outperformed standard chemotherapy in cancer of the upper throat in a phase 3 trial.
Toripalimab is a PD-1 inhibitor that is already approved for treatment of metastatic melanoma in China.
However Junshi is trying to develop toripalimab in niches that are not already occupied by the many competitors from the class where Merck & Co’s Keytruda (pembrolizumab) is the market leader.
Junshi said it is planning filings in China and other territories after the phase 3 JUPITER-02 trial met its primary endpoint at an interim analysis in first-line metastatic nasopharyngeal carcinoma.
The trial’s Independent Data Monitoring Committee said results showed that toripalimab in combination with gemcitabine and cisplatin significantly extended progression-free survival compared with the current standard treatment of gemcitabine and cisplatin.
The study enrolled 289 patients and its secondary endpoints include overall survival, objective response rate, duration of response, disease control rate, and safety.
In China, Junshi plans to file results with the country’s regulator, the National Medical Products Administration (NMPA) and other national regulators in the near future.
Toripalimab was first approved in second line metastatic melanoma in China in December 2018 and launched in February last year.
The company is trialling it in more than 30 clinical studies, covering more than 10 cancer indications in China, the US, and elsewhere.
Junshi says this will be the world’s first filing of a PD-1 checkpoint inhibitor for treatment of nasopharyngeal carcinoma.
This month the FDA granted toripalimab Breakthrough Therapy status for treatment of nasopharyngeal carcinoma, following orphan designation in nasopharyngeal carcinoma and soft tissue sarcoma.
It has also been granted orphan drug designation by the FDA for mucosal melanoma.
Junshi was founded in 2012 and since then has built a pipeline comprising of 26 innovative drugs and two biosimilars, covering five therapeutic areas – cancer, autoimmune, metabolic, neurologic, and infectious diseases.