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:

Squamous cell skin cancer
Basal cell carcinoma
Non-small cell lung cancer

Advanced squamous cell skin cancer

Libtayo is approved for:

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

Basal cell carcinoma

Libtayo is approved for:

  • Patients with basal cell carcinoma that has grown into nearby tissue (locally advanced) OR has spread to other parts of the body (metastatic), and who have been previously treated with a hedgehog pathway inhibitor (such as sonidegib [Odomzo] or vismodegib [Erivedge]) or who cannot be treated with a hedgehog pathway inhibitor.

Advanced non-small cell lung cancer

Libtayo is approved for:

  • Patients with non-small cell lung cancer that:
    • tests positive for high levels of the PD-L1 molecule, AND
    • does not have an abnormal EGFR, ALK, or ROS1 gene, AND
    • either has not spread outside the chest, but cannot be treated with surgery or chemotherapy with radiation, or has spread outside the chest.

In such cases, Libtayo may be used alone as a first treatment of the advanced disease.

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.
Complications of stem cell transplant: Serious and life-threatening complications that can lead to death can occur in patients who have received a stem cell transplant from a stem cell donor before or after being treated with Libtayo.


What type of immunotherapy is this?

Checkpoint Blockade

  • PD-1 blockade

How does this drug work?

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?

For:

Advanced squamous cell carcinoma
Basal cell carcinoma
Advanced non-small cell lung cancer

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 squamous cell carcinoma

In a clinical trial, 137 patients with squamous cell skin cancer who could not receive surgery or radiation were treated with Libtayo every two weeks. 

Among 78 patients with squamous cell skin cancer that had grown at the initial tumor site at median follow-up of 9 months: 

Results after treatment with Libtayo (diagram)

Among 59 patients with squamous cell skin cancer that had spread to other parts of the body, at median follow-up of 17 months:

Results after treatment with Libtayo (diagram)

Basal cell carcinoma (BCC)

In a clinical trial, 112 patients with advanced basal cell carcinoma who were previously treated with a hedgehog pathway inhibitor (such as sonidegib [Odomzo] or vismodegib [Erivedge]) and it did not work, or who could not be treated with a hedgehog pathway inhibitor, were treated with Libtayo. At a median follow-up of 10 months for patients whose cancer had spread to other parts of the body (metastatic) and 15 months for patients whose cancer had grown into nearby tissue (locally advanced), but had not spread to other parts of the body:

Comparative results between metastatic BCC vs locally advanced BCC (diagram)

Advanced non-small cell lung cancer

In a clinical trial, 710 patients with advanced non-small cell lung cancer that tested positive for high levels of the PD-L1 molecule, did not have an abnormal EGFR, ALK, or ROS1 gene, could not be treated with surgery or chemotherapy with radiation, or had spread outside the chest, and who had not received treatment for their advanced disease, were treated with either Libtayo or chemotherapy (platinum-based chemotherapy (followed by optional pemetrexed therapy). At at median follow-up of 13 months:

Results after treatment with Libtayo vs chemo (diagram)


What are the side effects?

The most common side effects of Libtayo include tiredness, body aches, rash, itching, decreased appetite, diarrhea, pneumonia, and cough.

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 (which 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). Libtayo may cause Type 1 diabetes. Skin rash (which could become severe and life-threatening), problems with the heart or eyes, and reactions related to the infusion may also occur.

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

Other references

Last updated on March 1, 2022


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