Providing the first marketed option for advanced nasopharyngeal carcinoma (NPC), the U.S. FDA approved Loqtorzi (toripalimab-tpzi) late in the day Oct. 27 for use in combination with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent locally advanced disease, and as a monotherapy for those with recurrent, unresectable or metastatic NPC with disease progression following chemotherapy.

The breakthrough therapy drug, a next-generation PD-1 monoclonal antibody that blocks PD-L1 and PD-L2, was developed by Shanghai Junshi Biosciences Co. Ltd. and is partnered in the U.S. with Coherus Biosciences Inc. as part of a $1.1 billion deal in early 2021. Coherus advanced the product to a BLA, but the FDA issued a complete response letter in 2022 due to problems conducting on-site manufacturing inspections as a result of COVID-19-related travel restrictions.

The recommended dose when used with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. As a monotherapy, the recommended dose is 3 mg/kg every two weeks until disease progression or unacceptable toxicity.

Loqtorzi is expected to be available for patients in the first quarter of 2024.

The Jupiter-02 phase III study and the Polaris-02 phase II study supported the approval, which is irrespective of a patient’s PD-L1 status. Jupitor-02 showed Loqtorzi and chemotherapy significantly improved progression-free survival, reducing the risk of disease progression or death by 48%, and it demonstrated a statistically significant improvement in overall survival, by way of a 37% reduction in the risk of death. Safety was consistent with the PD-1 inhibitor class and was similar between the two arms. Adverse events leading to discontinuation were immune-related, with those grade 3 or above more frequent with the Loqtorzi arm. Polaris-02 showed durable antitumor activity in patients who had failed chemotherapy, with a 20.5% objective response rate, a 40% disease control rate and a median overall survival of 17.4 months.

An aggressive cancer, NPC starts in the nasopharynx, where surgery is rarely an option. Until now, patients were treated with radiation and chemotherapy.

Junshi granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize toripalimab in May as part of a $728.3 million deal, covering Latin America, India and South Africa. Rights in the Middle East and North Africa belong to Hikma Pharmaceuticals plc, and Rxilient Biotech Pte Ltd. formed a joint venture with Junshi to develop and commercialize toripalimab in nine Southeast Asian nations.