The Food and Drug Administration (FDA) approved Loqtorz (toripalimab-tpzi) plus cisplatin and gemcitabine for the frontline treatment of patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma. Loqtorz was also approved as a single agent for patients with unresectable, recurrent or metastatic nasopharyngeal carcinoma that progressed on or after platinum-based chemotherapy, according to the agency.
The approval for the Loqtorz/chemotherapy combination is based off findings from the JUPITER-02 trial, which involved 289 patients who had not received prior treatment. Patients were randomly assigned to receive Loqtorz plus cisplatin and gemcitabine, followed by Loqtorz or placebo with cisplatin and gemcitabine, followed by placebo.
Findings showed that the Loqtorz-containing regimen had a better median progression-free survival (time from treatment until disease worsening or death) of 11.7 months, compared to eight months in the placebo group. Overall survival (time from treatment until death of any cause) was also improved with the Loqtorz group, with median overall survival not being reached in patients who received the Loqtorz regimen, meaning that not enough patients died for researchers to determine an average, while it was 33.7 months in the chemotherapy-only group.
The single-agent approval is based off findings from the POLARIS-02 trial, which involved 172 patients with unresectable (disease that is unable to be removed via surgery) or metastatic nasopharyngeal carcinoma that was previously treated with platinum-based chemotherapy or had disease progression within six months of finishing platinum therapy.
The main goal of the trial was overall response rate (percentage of patients whose disease shrinks or disappears from treatment), as well as duration of response (how long responses last until disease worsens). Overall response was 21%, with a median duration of response of 14.9 months.
Loqtorz led to immune-mediated side effects, such as pneumonitis, colitis, encocrinopathies, nephritis, as well as kidney dysfunction and skin-related side effects also occurring. The most common side effects, which occurred in 20% or more of patients given Loqtorz plus cisplatin and gemcitabine were nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, fever, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory tract infection, difficulty sleeping, dizziness and malaise. The most common side effects for single-agent Loqtorz were fatigue, hypothyroidism and musculoskeletal pain.
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