Toripalimab

Generic name: toripalimab
Brand name: Loqtorzi
Dosage form: intravenous infusion
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 30, 2023.

What is toripalimab?

Toripalimab-tpzi (Loqtorzi) is a PD-1 inhibitor used for the treatment of advanced nasopharyngeal carcinoma (NPC). Toripalimab-tpzi is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-L1 and PD-L2, which allows the immune system to activate and kill the tumor. Toripalimab-tpzi works by blocking the PD-1 receptor on tumor cells so the immune system is more able to attack and kill tumor cells.

Toripalimab-tpzi is given as an intravenous infusion every two or three weeks, depending on your treatment regime.

Loqtorzi brand of toripalimab-tpzi received FDA approval on October 27, 2023, based on positive results from the Phase II clinical study POLARIS-02 and the Phase 3 clinical trial JUPITER-02. Loqtorzi is FDA-approved to treat adults as:

• as a first treatment when NPC has spread to other parts of the body (metastatic) or has returned (recurrent) in nearby tissues (locally advanced), when used together with gemcitabine and cisplatin
• you have received chemotherapy that contains platinum, and it did not work or is no longer working, and NPC has returned and cannot be removed with surgery or has spread (metastatic).

How well does toripalimab work?

In the JUPITER-02 Phase 3 clinical trial, toripalimab reduced the risk of cancer progression or death by 48% compared to using chemotherapy alone, and toripalimab also improved overall survival, with a 37% reduction in the risk of death compared to chemotherapy alone.

How does toripalimab work?

In some cancers, there is a receptor called programmed cell death protein 1 (PD-1) on the outside tumor cells that lowers the ability of the immune system to attack the tumor cells. By blocking this receptor, the immune system is able to fight the cancer better. Toripalimab is a monoclonal antibody against PD-1 that blocks the PD-1 receptor so that the immune system is no longer inhibited and is more able to attack and kill tumor cells. Toripalimabi is also thought to lower the number of PD-1 receptors on the outside of the cancer cells by causing the PD-1 receptor to be absorbed inside the cancer cells.

What is nasopharyngeal carcinoma?

Nasopharyngeal carcinoma (NPC) is an aggressive cancer that starts in the nasopharynx, which is the upper part of the throat behind the nose and near the base of the skull. Because of where the cancer is, surgery is rarely an option, so most patients whose cancer is localized are treated mainly with radiation and chemotherapy

Toripalimab side effects

The most common toripalimab side effects when used as a single therapy are fatigue, hypothyroidism, and musculoskeletal pain these occurred in 20% or more of patients.

The most common toripalimab side effects when used in combination with cisplatin and gemcitabine are nausea, vomiting, decreased appetite, constipation, low thyroid levels, rash, fever, diarrhea, peripheral neuropathy, cough, muscle and joint pain, upper respiratory infection, trouble sleeping, dizziness, and malaise, these side effects affected 20% or more of patients.

Also see the warning section below for serious side effects.

These are not all the possible side effects of toripalimab. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warning

Toripalimab treats nasopharyngeal cancer by working with your immune system, so it may cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Call your healthcare provider right away if while taking toripalimab you develop any new or worse signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain Intestinal problems
• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of skin or the whites of your eyes
• dark urine (tea colored)
• severe nausea or vomiting
• bleeding or bruising more easily than normal
• pain on the right side of your stomach-area (abdomen)

Hormone gland problems

• headaches that will not go away or unusual headaches
• urinating more often than usual
• eye sensitivity to light
• hair loss
• eye problems
• feeling cold
• rapid heartbeat
• constipation
• increased sweating
• your voice gets deeper
• extreme tiredness
• dizziness or fainting
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• change in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• swelling of your ankles
• blood in your urine
• loss of appetite

Skin problems

• rash
• Itching
• painful sores or ulcers in your mouth or in your nose, throat, or genital area
• skin blistering or peeling
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with this medicine. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening.

Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include:

• chills or shaking
• dizziness
• itching or rash
• feeling like passing out
• Flushing
• Fever
• shortness of breath or wheezing
• back pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with toripalimab. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with toripalimab. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with toripalimab if you have severe side effects.

Before taking this medicine

Before taking toripalimab tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Toripalimab can harm your unborn baby.

Tell you healhcare providers if you are pregnant or plan to become pregnant.

Females who are able to become pregnant should have a negative pregnancy test before you start treatment with toripalimab. You should use an effective method of birth control during your treatment and for 4 months after your last dose of this medicine. Talk to your healthcare provider about the best birth control methods that you can use during this time. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with toripalimab.

Breastfeeding

Do not breastfeed during treatment and for 4 months after the last dose of toripalimab.

Tell you healhcare providers if you are breastfeeding or plan to breastfeed. It is not known if toripalimab passes into your breast milk.

How will I receive toripalimab?

Toripalimab is as a intravenous (IV) infusion into your vein through an intravenous (IV) line which takes 30 or 60 minutes. The IV infusion will be given to you by your healthcare provider.

Toripalimab is usually given every two or three weeks.

Your healthcare provider will decide how many treatments you need.

You will need to have regular blood tests to check for certain toripalimab side effects.

Dosing information

Recommended adult toripalimab dose for First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine: 240 mg every three weeks.

Recommended adult toripalimab dose Previously Treated Unresectable or Metastatic NPC: 3 mg/kg every two weeks.

Related/similar drugs

cisplatin, fluorouracil, paclitaxel, gemcitabine, Loqtorzi, toripalimab

What happens if I miss a dose?

If you miss any appointments, call your healthcare provider as soon as possible to reschedule.

What other drugs will affect toripalimab?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Not all possible interactions are listed here.

Storage

Storage of toripalimab vials

• Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Do not shake.

Storage of Diluted toripalimab Solution for Infusion

Toripalimab does not contain a preservative.

If the diluted solution is not administered immediately, store either:

• At room temperature, 20℃ to 25℃ (68°F to 77°F), for no more than 8 hours from the time oof dilution to the completion of the infusion. Discard diluted solution stored at room temperature after 8 hours, or,
• Refrigerated at 2℃ to 8℃ (36°F to 46°F) for no more than 24 hours from the time of dilution to the completion of the infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Discard the refrigerated diluted solution after 24 hours.
• Do not freeze.

Ingredients

Loqtorzi Active ingredient: toripalimab-tpzi

Loqtorzi Inactive ingredients: citric acid monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Manufacturer

Loqtorzi Manufactured and Distributed by: Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065, USA.

Toripalimab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for toripalimab.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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