Cemiplimab-rwlc (Libtayo)

How is this drug name pronounced?

Generic name: seh-MIP-lih-mab

Brand name: lib-TY-oh


What cancer(s) does this drug treat?

Libtayo is approved for:

Advanced cutaneous squamous cell carcinoma (CSCC)

Patients with squamous cell skin cancer that has grown or spread, and who cannot receive surgery or radiation.

Limitations of use:

Age: The safety and efficacy of Libtayo in patients under 18 years of age have not been established.
Pregnancy/Breastfeeding: Libtayo can cause harm to a fetus, and is not recommended for use during pregnancy. The risks associated with Libtayo during breastfeeding are not known and cannot be ruled out; due to the potential for serious adverse reactions to the breastfed child, women are advised not to breastfeed during treatment and for at least 4 months after the last dose of Libtayo.


What type of immunotherapy is this?

Checkpoint Blockade

  • PD-1 blockade

How does this drug work?

  • Target: PD-1

Libtayo is an antibody that attaches to a molecule called PD-1, which is present on the surface of T cells – the primary immune cells involved in killing cancer cells. In healthy tissues, PD-1 acts as a brake that keeps T cells from creating an immune reaction that gets out of control. However, cancers can hijack this safety mechanism and prevent T cells from doing their job – killing the cancer cells. This can happen when cancer cells or other cells within the tumor mass display on their surface molecules called PD-L1 or PD-L2. When PD-L1 or PD-L2 interact with PD-1 on T cells, the T cells become inactive and do not attack the cancer cells. Libtayo binds to the PD-1 molecules on T cells in such a way that prevents the interaction between PD-1 and PD-L1/PD-L2, and allows the T cells to be active and attack the cancer cells.

Illustration of how Libtayo works


How is this drug given to the patient?

Libtayo is administered via a tube into a vein (intravenous infusion, or I.V.) over 30 minutes every three weeks and does not require a hospital stay.


What are the observed clinical results?

It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Advanced cutaneous squamous cell carcinoma (CSCC)

Combined data from the two ongoing clinical trials showed that in the first 108 treated patients:

Data collected from two clinical trials showing the results of Libtayo (diagram)


What are the side effects?

The most common side effects of Libtayo include tiredness, rash, and diarrhea.

Libtayo can cause the patient’s T cells to attack healthy cells throughout the body. Because of this, Libtayo can cause side effects that can become serious or life-threatening, and may lead to death. Some of the serious side effects related to Libtayo include inflammation of the lungs, liver, brain, kidneys (which can lead to kidney failure), or colon (that can result in tears or holes in the intestine). Additionally, problems can arise with hormone glands (including thyroid, pituitary, and adrenal glands, as well as the pancreas), skin rash (which could become severe and life-threatening), and reactions related to the infusion. Patients should report any symptoms to their healthcare provider who can then initiate actions to limit or reverse the side effects.

For a more complete list of possible side effects, see the full prescribing information.


Additonal Information

Manufacturer

Regeneron

Approval

FDA and EMA


Understanding Cancer Immunotherapy Research

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