The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient's PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.
In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
The safety profile of LOQTORZI was consistent with the PD-1 inhibitor class. The incidence of Grade 3 adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) was similar between the two arms. AEs leading to discontinuation of LOQTORZI versus placebo (11.6% vs 4.9%), immune-related adverse events (irAEs) (54.1% vs. 21.7%), and Grade 3 irAEs (9.6% vs. 1.4%) were more frequent in the LOQTORZI arm.
In the POLARIS-02 clinical study LOQTORZI demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.
NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. LOQTORZI is the first FDA-approved agent for NPC patients.
'LOQTORZI's first approval is a pivotal event for Coherus as an innovative oncology company. As a next generation PD-1 inhibitor it is the keystone of our I-O strategy to extend cancer patient survival as shown with the impressive results in NPC,' said
'Today's FDA approval of LOQTORZI is very encouraging for those living with NPC who currently have very limited treatment options and are in need of new therapies to treat this aggressive and life-threatening form of cancer,' said
The recommended LOQTORZI dose with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended LOQTORZI dose as a single agent for previously treated NPC is 3 mg/kg every two weeks until disease progression or unacceptable toxicity.
LOQTORZI is expected to be available in
'The impressive results from JUPITER-02 and POLARIS-02 have provided conclusive evidence that establishes toripalimab, in combination with chemotherapy or as monotherapy, as the standard therapy for advanced NPC,' said Professor
'We're excited to reach another significant company milestone of 'going overseas',' said Dr.
About JUPITER-02
JUPITER-02 is the largest randomized, double-blind, placebo-controlled, international, multi-center Phase 3 clinical study to evaluate a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic NPC.
Two hundred eighty-nine patients with advanced NPC who had received no prior chemotherapy for recurrent/metastatic disease were randomized 1:1 to receive LOQTORZI (toripalimab-tzpi) 240 mg or placebo in combination with gemcitabine 1000 mg/m2 (days 1 and 8) and cisplatin 80 mg/m2 (day 1) of every three-week treatment cycle, followed by toripalimab-tzpi or placebo monotherapy every 3 weeks until disease progression, intolerable toxicity, or completion of two years of treatment. JUPITER-02 included all eligible patients regardless of PD-L1 status and histologies.
In this study, LOQTORZI met the primary endpoint, demonstrating a significant improvement in PFS (assessed by a Blinded Independent Review Committee (BIRC)) compared to the chemotherapy alone arm with toripalimab-tzpi, reducing the risk of disease progression or death by 48% (HR=0.52 [95% CI: 0.36, 0.74; P
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