Toripalimab Becomes First Approved Immunotherapy for Recurrent Unresectable/Metastatic NPC in Canada

Health Canada has approved toripalimab-tpzi (Loqtorzi) for the treatment of patients with nasopharyngeal carcinoma (NPC).¹With this regulatory decision, toripalimab is now the first and only Health Canada–approved immunotherapy available in Canada for patients with recurrent unresectable or metastatic NPC.

The agent’s current indications are as follows:

• in combination with cisplatin and gemcitabine for patients with metastatic or recurrent locally advanced NPC
• as monotherapy for those with recurrent unresectable or metastatic NPC who have progressed following platinum-based chemotherapy

Findings from the phase 3 JUPITER-02 trial (NCT03581786) and phase 2 POLARIS-02 trial (NCT02915432) support the agent’s approval in combination with cisplatin and gemcitabine and as monotherapy, respectively.²

Data from JUPITER-02 and POLARIS-02 also supported the October 2023 FDA approval of toripalimab for these indications.³

"[Toripalimab] exemplifies our commitment to Canadian patients and the health care system," Allan Oberman, president and chief executive officer of Apotex, stated in a news release.¹ "As the first and only Health Canada–approved immunotherapy for both the first and later-line treatment of this unique cancer, it delivers a transformative therapy where none previously existed, addressing a critical unmet need."

Toripalimab is a humanized IgG4 monoclonal antibody.² By binding to the PD-1 receptor and blocking its interaction with PD-L1 and PD-L2, toripalimab prevents PD-1 pathway–mediated inhibition of the antitumor immune response.

"The availability of [toripalimab] in Canada is a meaningful step forward for patients diagnosed with [NPC]," Nathaniel Bouganim, MDCM, a medical oncologist and division director of Medical Oncology at McGill University Health Centre, concluded in the news release.¹ "Having this therapy accessible through a Canadian-based pharmaceutical company like Apotex helps promote equitable care for those facing this rare disease.”

What did the JUPITER-02 trial show with toripalimab plus cisplatin/gemcitabine for first-line NPC?

JUPITER-02 was a randomized, multicenter, single-region, double-blind, placebo-controlled trial involving 289 patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease.^2,3

Patients were randomly assigned to receive either intravenous (IV) toripalimab at 240 mg every 3 weeks combined with cisplatin and gemcitabine for up to 6 cycles, followed by toripalimab monotherapy once every 3 weeks; or IV placebo every 3 weeks combined with cisplatin and gemcitabine, followed by placebo once every 3 weeks.² Treatment continued until disease progression, unacceptable toxicity, or a maximum of 2 years.

The study’s primary end point was progression-free survival (PFS), which was determined by a blinded independent review committee (BICR) according to RECIST 1.1 criteria. Overall survival (OS) served as an additional end point.³

Key efficacy results from JUPITER-02 were as follows:^2,3

• PFS: The median PFS for the toripalimab combination arm was 11.7 months (95% CI, 11.0-not evaluable [NE]) vs 8.0 months (95% CI, 7.0-9.5) in the placebo arm (HR, 0.52; 95% CI, 0.36-0.74; P = .0003).
• OS: A statistically significant OS improvement was also observed. The median OS was NE (95% CI, 38.7-NE) for the toripalimab-containing regimen and 33.7 months (95% CI, 27.0-44.2) for the placebo-containing regimen (HR, 0.63; 95% CI, 0.45-0.89; P = .0083).
• Objective response rate (ORR): The ORR as assessed by BICR was 77.4% (95% CI, 69.8%-83.9%) with the combination vs 66.4% (95% CI, 58.1%-74.1%) in the placebo arm.

How effective is toripalimab monotherapy in previously treated NPC?

POLARIS-02 was an open-label, multicenter, single-country trial that enrolled 172 patients with unresectable or metastatic NPC who had received prior platinum-based chemotherapy or had experienced disease progression within 6 months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.³

Upon enrollment, patients received toripalimab at 3 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity. The major efficacy outcome measures were confirmed ORR and duration of response (DOR) per BICR using RECIST 1.1 criteria.

Key efficacy results from POLARIS-02 were as follows:^2,3

• ORR: The confirmed ORR per BICR was 21% (95% CI, 15%-28%). This included a complete response rate of 2.3% and a partial response rate of 19%.
• DOR: The median DOR was 14.9 months (95% CI, 10.3-NE).

What are the key safety considerations for toripalimab?

Toripalimab is associated with immune-mediated adverse effects (AEs) such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.³

The most common AEs (≥20%) for toripalimab plus 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 AEs (≥20%) for toripalimab as a single agent were fatigue, hypothyroidism, and musculoskeletal pain.

References

1. Apotex receives Health Canada approval for Loqtorzi – the first and only immuno-therapy for recurrent unresectable or metastatic nasopharyngeal cancer.News release. Apotex. October 23, 2025. Accessed October 24, 2025. https://www.apotex.com/global/news/news-release/2025/10/23/apotex-receives-health-canada-approval-for-loqtorzi-the-first-and-only-immuno-therapy-for-recurrent-unresectable-or-metastatic-nasopharyngeal-cancer
2. Toripalimab. Product Monograph. Apotex. Updated October 17, 2025. Accessed October 24, 2025. https://pdf.hres.ca/dpd_pm/00082094.PDF
3. FDA approves toripalimab-tpzi for nasopharyngeal carcinoma. FDA. Updated October 30, 2023. Accessed October 24, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma