Loqtorzi

Pronunciation: lok tor zee
Generic name: toripalimab-tpzi
Dosage form: injection single-dose vial (240 mg/6 mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 8, 2024.

What is Loqtorzi?

Loqtorzi is used to treat advanced nasopharyngeal carcinoma (NPC), which is a certain type of cancer of the nose or throat. Loqtorzi works by blocking the PD-1 receptor on tumor cells so the immune system is more able to attack and kill tumor cells. Loqtorzi (toripalimab-tpzi) is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-L1 and PD-L2, allowing the immune system to activate and kill the tumor. Loqtorzi is called a PD-1 inhibitor.

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

Loqtorzi FDA approval was received 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 Loqtorzi work?

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

How does Loqtorzi 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. Loqtorzi 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. Loqtorzi 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

Loqtorzi side effects

Common Loqtorzi side effects

The most common Loqtorzi 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 Loqtorzi 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.

Serious Loqtorzi side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, skin sores, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Toripalimab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Loqtorzi may cause serious side effects. Call your doctor at once if you have:

• intestinal problems  - severe stomach pain, diarrhea, bloody or tarry stools;
• liver problems - loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• immune system problems - confusion, problems with thinking or memory, balance problems, trouble breathing, weakness, muscle cramps, irregular heart rhythm or swelling of ankles;
• signs of organ transplant rejection - feeling sick or uneasy, with pain or swelling near your transplanted organ;
• signs of a hormonal disorder - unusual headaches, vision problems, feeling light-headed, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;
• lung problems - cough, shortness of breath, chest pain;
• kidney problems - swelling, urinating less, feeling tired or short of breath; or
• low red blood cells (anemia) - pale skin, tiredness, feeling light-headed, cold hands and feet.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

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

Before taking this medicine

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

Loqtorzi 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 Loqtorzi. 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 Loqtorzi.

Breastfeeding

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

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

How will I receive Loqtorzi?

Loqtorzi 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.

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

Dosing information

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

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

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 Loqtorzi?

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.

Related/similar drugs

fluorouracil, cisplatin, paclitaxel, gemcitabine, toripalimab

Loqtorzi Package Insert 

Review the Loqtorzi Package Insert for more detailed information about this medicine. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

Storage of 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 Solution for Infusion

Loqtorzi 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

Active ingredient: toripalimab-tpzi

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

Manufacturer

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

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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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