Shanghai Junshi Biosciences Co., Ltd., a prominent biopharmaceutical firm focused on innovation, along with its subsidiary TopAlliance Biosciences Inc., has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization application (MAA) of toripalimab (European trade name: LOQTORZI®). The CHMP has recommended toripalimab for two indications:

1. In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, non-surgical or non-radiotherapy amenable, or metastatic nasopharyngeal carcinoma (NPC).
2. In combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).

The final decision will be made by the European Commission, which will consider the CHMP’s recommendation. If approved, toripalimab will be the first drug available for NPC and the only first-line treatment for advanced or metastatic ESCC in Europe, regardless of PD-L1 status.

Junshi Biosciences, said, “Receiving this positive opinion from the CHMP marks a crucial step towards providing European patients with toripalimab, which could significantly improve treatment options for NPC and ESCC. We are committed to working with regulatory authorities to make this innovative therapy accessible to more patients in Europe.”

TopAlliance Biosciences, added, “The CHMP’s positive opinion highlights the meaningful clinical benefits of adding toripalimab to chemotherapy for patients with metastatic or recurrent NPC and ESCC. We anticipate that toripalimab will soon be available in Europe, complementing its existing availability in China and the United States.”

NPC is a prevalent head and neck cancer that is typically not treatable with surgery due to its location. According to GLOBOCAN 2022, there were over 120,000 new cases of NPC worldwide in 2022. The ESMO Guidelines recommend combining immunotherapy with chemotherapy for treating recurrent or metastatic NPC.

The CHMP’s opinion on NPC is based on the JUPITER-02 Phase III trial results, which were featured at the 2021 ASCO Annual Meeting and published in Nature Medicine and JAMA.

Esophageal cancer (EC) is a major cancer type, with over 511,000 new cases and 445,000 deaths globally in 2022. ESCC and esophageal adenocarcinoma are the two main types. The ESMO Guidelines suggest using PD-1 inhibitors in combination with chemotherapy for treating advanced or metastatic ESCC with positive PD-L1 status.

The CHMP’s opinion on ESCC is based on the JUPITER-06 Phase III trial results, which were presented at the 2021 ESMO Congress and published in Cancer Cell and Journal of Clinical Oncology.

Toripalimab is an anti-PD-1 monoclonal antibody designed to block the interactions between PD-1 and its ligands, PD-L1 and PD-L2. This mechanism enhances the immune system's ability to target and destroy tumor cells.

Junshi Biosciences has conducted over forty clinical trials of toripalimab across various cancer types globally, including in China, the U.S., Southeast Asia, and Europe. These studies cover a broad spectrum of cancers, including those of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

 

Source: globenewswire.com

Report Abuse