Reading Time: 3 minutes

Shanghai Junshi Biosciences Co., Ltd , a pioneer in biopharmaceutical innovation focused on crafting, advancing, and marketing new treatment solutions, along with its wholly-owned affiliate TopAlliance Biosciences Inc., is pleased to announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed the marketing authorization application (MAA) for toripalimab (marketed in Europe as LOQTORZI®). The CHMP has recommended its approval for two specific uses:

1. Toripalimab, in combination with cisplatin and gemcitabine, as a primary treatment for adult patients with recurrent, surgically inoperable, or metastatic nasopharyngeal carcinoma (NPC);
2. Toripalimab, when used with cisplatin and paclitaxel, as a primary treatment for adult patients with inoperable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).

The European Commission will consider the CHMP’s favorable recommendation in its final verdict on the marketing application for toripalimab. This decision will affect all 27 European Union member states, as well as Iceland and Norway. Upon approval, toripalimab is poised to be the inaugural and sole therapy for NPC and the first-line treatment for advanced or metastatic ESCC in Europe, independent of PD-L1 status.

“As a leading innovative pharmaceutical company in China,” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Junshi Biosciences is dedicated to addressing the clinical needs of local patients while offering novel therapies that provide survival benefits to patients globally. Currently, patients with NPC and ESCC in Europe receive limited clinical benefits from existing treatments. Toripalimab has the potential to improve their treatment options. The positive opinion from the CHMP brings us one step closer to this goal. We will continue communicating with local regulatory authorities so that our innovative therapy can benefit more European patients as soon as possible.”

“The CHMP’s positive opinion is based on the robust and clinically important benefits with the addition of toripalimab to first-line chemotherapy in patients with metastatic or recurrent NPC or ESCC, not amenable to local therapy,” Dr. Patricia Keegan, CMO of TopAlliance Biosciences, said. “Adding toripalimab to chemotherapy has shown significantly and meaningful improvements in overall survival in both tumor types. This positive opinion suggests that our innovative product, already launched in China and the United States, is likely to reach Europe as well.”

Nasopharyngeal carcinoma (NPC) is a type of cancer that develops in the epithelial cells of the nasopharynx and is among the more prevalent cancers of the head and neck worldwide. The 2022 GLOBOCAN statistics reveal that over 120,000 new cases of NPC were diagnosed globally in 2022. The anatomical position of NPC typically makes surgical interventions impractical. Current guidelines from the European Society for Medical Oncology (ESMO) advocate for a combination of immunotherapy and chemotherapy as the primary approach for treating recurrent or metastatic NPC.

The CHMP’s endorsement of the NPC treatment stems from findings in the JUPITER-02 study, a comprehensive Phase III clinical trial conducted internationally across multiple centers. This trial was double-blind and placebo-controlled (NCT03581786). The significant outcomes of this study were highlighted through an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2) and were featured on the cover of Nature Medicine. These findings were further detailed in the Journal of the American Medical Association (JAMA).

Esophageal Cancer (EC) ranks as one of the top malignancies affecting the digestive system. As per the GLOBOCAN 2022 report, EC stood as the 11th most frequently diagnosed cancer and the seventh leading cause of cancer mortality globally, with over 511,000 new cases and more than 445,000 deaths in 2022. Esophageal squamous cell carcinoma (ESCC) and esophageal adenocarcinoma are the primary histological variants of EC. For patients with advanced or metastatic ESCC showing a positive PD-L1 status, the ESMO Guidelines recommend first-line treatment with PD-1 inhibitors alongside chemotherapy.

The CHMP’s approval for the ESCC treatment indications is largely based on the JUPITER-06 study, another pivotal Phase III trial that was randomized, double-blinded, and placebo-controlled across various centers (NCT03829969). Key results from this study were initially presented at the ESMO Congress 2021 and subsequently published in Cancer Cell and the Journal of Clinical Oncology, both esteemed in the field of oncology.