Junshi tees up China filing for PD-1 med after throat cancer win

Junshi Biosciences' PD-1 blocker is already approved in China as a second-line treatment for metastatic melanoma. But the company’s not stopping there—it plans to add other cancer types to the drug’s label, starting with a form of throat cancer.

The drug, toripalimab, along with standard-of-care chemotherapy duo gemcitabine and cisplatin, beat chemo alone at staving off cancer progression in patients with nasopharyngeal carcinoma, leading a data monitoring committee to deem the study a success. The results come from a phase 3 study of 289 patients whose disease had spread or come back after undergoing treatment such as radiation or surgery.

The Shanghai-based biotech plans to file the drug for approval in China, as well as in other countries, “in the near future,” according to a statement.

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Junshi is testing toripalimab as a treatment for more than 10 kinds of cancer in more than 30 trials worldwide. The drug is already under review by Chinese regulators for the treatment of throat cancer that has not responded to at least two systemic cancer treatments, as well as bladder cancer that has spread either locally or to other parts of the body.

Stateside, the anti-PD-1 antibody has snagged orphan drug status as a single agent for throat cancer and soft tissue sarcoma as well as for mucosal melanoma in combination with Pfizer’s Inlyta. It also has a breakthrough tag for throat cancer.

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“Junshi prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer, but we found that great unmet medical needs also exist in other countries where patients are endangered by this deadly disease. The (breakthrough designation) will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously,” said Junshi CEO Ning Li, M.D., Ph.D., in a statement earlier this month.