Penpulimab-kcqx is now FDA-approved for adults with certain advanced forms of non-keratinizing nasopharyngeal carcinoma (NPC). It can be used in combination with chemotherapy (cisplatin or carboplatin and gemcitabine) as a first treatment for adults with recurrent or metastatic disease or as a single agent for adults whose metastatic disease has worsened after platinum-based chemotherapy and at least one other prior therapy.
What is Penpulimab?
Penpulimab is a type of immunotherapy called a PD-1 inhibitor. Penpulimab is a new type of PD-1 antibody treatment designed with a special IgG1 structure and a modified Fc region. This unique mechanism of action is thought to potentially work more effectively against cancer by boosting the immune system’s attack on tumor cells, while also reducing the risk of certain immune-related side effects that can occur with other similar treatments
Who Can Receive This Treatment?
- Adults with recurrent or metastatic non-keratinizing NPC who have not had chemotherapy for advanced disease can receive penpulimab with chemotherapy as their first treatment.
- Adults with metastatic non-keratinizing NPC whose cancer has progressed after platinum-based chemotherapy and at least one other treatment can receive penpulimab on its own.
How Effective Is Penpulimab?
- In a clinical trial (AK105-304), patients who received penpulimab with chemotherapy lived longer without their cancer worsening (median progression-free survival of 9.6 months) compared to those who received chemotherapy alone (7.0 months).
- In another trial (AK105-202), 28% of patients who received penpulimab alone saw their tumors shrink. The length of time these responses lasted could not be determined at the time of the study.
What Are the Most Common Side Effects?
- When used with chemotherapy: nausea, vomiting, hypothyroidism (low thyroid), constipation, decreased appetite and weight, cough, COVID-19 infection, fatigue, rash, and fever.
- When used alone: hypothyroidism and muscle or joint pain.
- Serious, but rare, side effects include lung inflammation, colitis (bowel inflammation), hepatitis, and severe infections.
How Is Penpulimab Given?
- With chemotherapy: 200 mg every three weeks, up to 24 months or until the cancer worsens or side effects become unacceptable.
- Alone: 200 mg every two weeks, up to 24 months or until the cancer worsens or side effects become unacceptable.
What Does This Mean for Patients?
This approval offers a new treatment option for adults with advanced non-keratinizing nasopharyngeal carcinoma, both for those starting their first treatment and those whose cancer has returned or worsened after other therapies. If you have questions about whether penpulimab is right for you, talk to your cancer care team.
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