Drug intelligence / Profile preview

5-fluorouracil + cisplatin + toripalimab

Development stage
Unknown
Lead developer
Junshi Biosciences
Modality
Vaccines & Immunotherapeutics, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Intravenous
01

Overview

The combination of 5-fluorouracil (5-FU) and cisplatin has been used as a chemotherapy regimen for various cancers, particularly head and neck cancers and anal cancers. Toripalimab is a newer PD-1 inhibitor that was approved by the FDA in October 2023 for nasopharyngeal carcinoma (NPC). ## Drug Components **5-Fluorouracil (5-FU)** 5-Fluorouracil is a chemotherapy drug that destroys quickly dividing cells, such as cancer cells[1]. It's administered intravenously, often through a central line, PICC line, or portacath[1]. **Cisplatin** Cisplatin is also a chemotherapy drug that works by destroying quickly dividing cells[1]. It's typically administered as a drip for between 1 and 8 hours, with extra fluids given before and after to protect the kidneys[1]. **Toripalimab** Toripalimab is a PD-1 blocking antibody that works by blocking the PD-L1/PD-1 pathway, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response[6]. It was approved by the FDA in October 2023 for nasopharyngeal carcinoma[4][5]. ## Therapeutic Use While the specific combination of all three drugs (5-fluorouracil + cisplatin + toripalimab) is not explicitly mentioned in the search results, we can understand their potential combined use based on their individual mechanisms and approved indications: 1. 5-FU and cisplatin combination has shown effectiveness in: - Recurrent and disseminated epidermoid cancer of the head and neck with a 70% overall response rate[2] - Metastatic anal cancer with a 66% response rate[3] 2. Toripalimab was approved: - In combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma[4][5] - As a single agent for recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy[4][5] ## Administration and Dosing For the individual components: - 5-FU is typically administered as a continuous infusion for 4-5 days or continuously for 21 days[1][3] - Cisplatin is usually given as a 100 mg/m² IV bolus on day 1 with hydration and mannitol diuresis[2][3] - Toripalimab's recommended dosage is: - 240 mg every three weeks when used in combination therapy until disease progression, unacceptable toxicity, or up to 24 months[7] - 3 mg/kg every two weeks as a single agent until disease progression or unacceptable toxicity[7] ## Side Effects Common side effects of these drugs include: - For 5-FU and cisplatin: increased risk of infection, breathlessness, bruising and bleeding, changes to mineral levels in blood[1] - For toripalimab combination therapy: nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise[5] This combination represents an approach that combines traditional chemotherapy (5-FU and cisplatin) with modern immunotherapy (toripalimab), potentially offering enhanced efficacy through complementary mechanisms of action.

02

Targets

PDCD1 (Programmed cell death protein 1 receptor)DNATS (Thymidylate synthase)

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