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The FDA approved a new , for treating adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), representing the first drug specifically approved for this patient population.

Toripalimab gained indications as a first-line treatment (in combination with chemotherapy) and following progression on or after platinum-containing chemotherapy (as monotherapy) based on data from the JUPITER-02 and POLARIS-02 trials.

In the phase III JUPITER-02 trial, which involved 289 previously untreated patients with metastatic or recurrent locally advanced NPC, adding toripalimab to first-line cisplatin and gemcitabine chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS).

Median PFS reached 11.7 months for the group randomized to toripalimab compared with 8 months for those assigned to placebo (HR 0.52, 95% CI 0.36-0.74, P=0.0003). This improvement was observed regardless of PD-L1 status and histologies. Median OS was not reached in the toripalimab arm versus 33.7 months in the placebo arm (HR 0.63, 95% CI 0.45-0.89, P=0.0083).

Response rates also improved with the addition of the PD-1 inhibitor to the standard chemotherapy regimen, as did median duration of response (10 vs 5.7 months with chemotherapy plus placebo).

In the open-label, phase II -- which included 172 patients with unresectable or metastatic NPC who had received prior platinum-based chemotherapy or had disease progression within 6 months of completing chemotherapy -- toripalimab demonstrated durable antitumor activity, with an objective response rate of 20.5%, a disease control rate of 40%, and a median OS of 17.4 months.

"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 Ruihua Xu, MD, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, and the principal investigator of the two studies, in a from drugmakers Coherus BioSciences and Junshi Biosciences.

"We hope that this promising therapy will close the treatment gap for international NPC patients struggling to find effective therapies, bringing them renewed hope for better survival," he added.

The most common adverse reactions (≥20%) for toripalimab with cisplatin and gemcitabine were nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise. The most common adverse reactions (≥20%) for single-agent toripalimab were fatigue, hypothyroidism, and musculoskeletal pain.

Immune-mediated adverse reactions occurred with toripalimab, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.

The recommended toripalimab dose with cisplatin and gemcitabine is 240 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended toripalimab dose as a single agent for previously treated NPC is 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

Toripalimab should be available in the U.S. by the first quarter of 2024, according to Coherus and Junshi.

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