On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZI^TM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in combination with cisplatin and gemcitabine as treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and 2) as a single agent treatment in adults with recurrent, unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. [1]

NPC is a metastasis-prone head and neck cancer arising in the epithelial tissue of the nasopharynx. [2] While the exact cause of NPC is unknown, the cancer is closely associated with Epstein-Barr virus. [3]  A variety of other factors including genetics and the environment are also known to play a role. [4] NPC is rare in the United States, affecting fewer than 1 in 100,000 people, but is more prevalent in central, south and southeast Asia, the Arctic, Middle East, and North Africa. [5]

LOQTORZI^TM is a programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 on the PD-1 receptor.  [6] The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study. [7] In the JUPITER-02 Phase 3 clinical trial, LOQTORZI^TM reduced the risk of cancer progression or death by 48% compared to using chemotherapy alone, and LOQTORZI^TM also improved overall survival, with a 37% reduction in the risk of death as compared to chemotherapy alone. LOQTORZI^TM approval includes treatment irrespective of a patient’s PD-L1 status. [8]  In the POLARIS-02 clinical study LOQTORZI^TM showed antitumor activity in patients with recurrent or metastatic NPC who had failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, and a disease control rate (DCR) of 40.0%. [9]

LOQTORZI^TM is the first FDA approved treatment for NPC as well as the first FDA approved, Chinese developed, PD-1 inhibitor. [10] The global PD-1/PD-L1 inhibitor market is estimated to be approximately USD $50 billion in 2023 and is predicted to increase to approximately USD $123 billion by 2033. [11]. Unlike the approach Coherus took when pricing its Humira® biosimilar YUSIMRY^TM at about an 85% discount from the originator, Coherus CEO Denny Lanfear has indicated that Coherus will not engage in heavily discounted pricing with LOQTORZI^TM. [12]

References:

[1] See https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma.

[2] See Shah AB, Nagalli S. Nasopharyngeal Carcinoma. [Updated 2022 Oct 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554588/

[3] Id.

[4] Id.

[5] Id.

[6] See https://www.coherus.com/immuno-oncology/toripalimab-tpzi/.

[7] See https://investors.coherus.com/news-releases/news-release-details/coherus-and-junshi-biosciences-announce-fda-approval-loqtorzitm.

[8] Id.

[9] Id.

[10] See https://www.fiercepharma.com/pharma/first-china-made-pd-1-approved-fda-coherus-renounces-heavily-discounted-pricing-junshis.

[11] See https://www.futuremarketinsights.com/reports/pd1-pdl1-inhibitors-market.

[12]See https://investors.coherus.com/news-releases/news-release-details/coherus-announces-industry-wide-lowest-list-price-adalimumab.