TORIPALIMAB

On 27 October 2023, the U.S. FDA approved Toripalimab, a monoclonal antibody functioning as an immune checkpoint inhibitor. It treats cancers by blocking the PD-1 receptor, thereby enhancing the immune system's capacity to attack cancer cells. A clinical study of toripalimab demonstrated tolerability, with frequently reported treatment-related adverse events comprising fatigue (64%) and rash (24%). No severe adverse effects or treatment-related deaths were documented. The objective response rate was 12.5%, and the majority of patients sustained high PD-1 receptor occupancy on T cells. Toripalimab demonstrated anti-tumour activity in treatment-refractory advanced malignant tumours, indicating potential therapeutic value for further evaluation in additional malignancies and combination treatment approaches.

Toripalimab is indicated for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine. It is also used as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC that has progressed after platinum-containing chemotherapy.

Toripalimab is administered by your healthcare provider through an intravenous (IV) line into your vein over 30 to 60 minutes. It is typically given every two or three weeks as an IV infusion. Your healthcare provider will determine the number of treatments you need and will monitor your blood for any potential side effects. If you miss any appointments, it is important to contact your healthcare provider promptly to reschedule.

Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them. Common side effects of Toripalimab are: Nausea and vomiting Burning or feeling of pins and needles in feet and toes Decreased appetite Diarrhea Constipation Muscle and bone pain Low levels of thyroid hormone Upper respiratory infection Rash Sleep problems Fever and cough Dizziness Feeling generally unwell Serious side effects of Toripalimab are: Severe allergic reactions (e.g., difficulty breathing, swelling of face or throat) Liver problems (e.g., yellowing of skin or eyes, dark urine) Lung problems (e.g., shortness of breath, cough, chest pain) Immune system problems leading to inflammation in organs (e.g., colitis, hepatitis, or pneumonitis) Endocrine problems (e.g., adrenal or thyroid problems) Severe infections

Severe and fatal immune-mediated adverse reactions : Toripalimab can cause severe and fatal immune-mediated adverse reactions, affecting any organ system or tissue. Timing of reactions : Immune-mediated reactions can occur at any time during treatment or even after discontinuation of Toripalimab. Monitoring and intervention : Close monitoring for signs of immune-mediated reactions is essential, with immediate medical intervention required if necessary. Infusion-related reactions : Toripalimab may cause severe hypersensitivity and anaphylaxis during administration. Allogeneic hematopoietic stem cell transplantation (HSCT) Complications : Serious complications may arise in patients treated with Toripalimab before or after HSCT, including graft-versus-host disease (GVHD) and other transplant-related issues. Embryo-fetal toxicity : Toripalimab can cause fetal harm when administered to a pregnant woman, potentially leading to fetal death.

Doctors should closely monitor patients for any signs of immune-mediated reactions, including liver, thyroid, or lung problems, and conduct regular assessments for adverse effects. If severe reactions occur, they may need to interrupt or discontinue therapy. Additionally, they should exercise caution when administering the treatment to pregnant women due to the risk of fetal harm.

Monitor for immune-mediated adverse effects, including pneumonitis or hepatitis, and report any unusual symptoms to your doctor without delay. Regular blood tests are necessary to assess liver, kidney, and thyroid function. Women of reproductive potential should use effective contraception during treatment and for 4 months following completion. Adhere to your healthcare provider's guidance on dosing, management of adverse effects, and timely clinical review. Toripalimab contains no preservative. The diluted solution must be used within 8 hours when stored at room temperature (20°C to 25°C) or within 24 hours when refrigerated (2°C to 8°C). Do not freeze. Discard any remaining solution after these storage periods have elapsed.

1. Wei XL, Ren C, Wang FH, Zhang Y, Zhao HY, Zou BY, Wang ZQ, Qiu MZ, Zhang DS, Luo HY, Wang F, Yao S, Xu RH. A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors. https://pubmed.ncbi.nlm.nih.gov/32589350/ 2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761240s000lbl.pdf 3. Zhang L, Hao B, Geng Z, Geng Q. Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China. https://pmc.ncbi.nlm.nih.gov/articles/PMC8789657/ 4. https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf