REGN2810 (SAR439684) is an antibody-based cancer therapy that Regeneron Pharmaceuticals is developing in collaboration with Sanofi.

Researchers are conducting a number of clinical trials on REGN2810’s ability to fight cancer, including advanced cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).

In September 2017 the U.S. Food and Drug Administration gave REGN2810 breakthrough therapy designation as a treatment for adults with metastatic CSCC, the United States’ second most common skin cancer.

How REGN2810 works

REGN2810 is a monoclonal antibody, or manmade copy of a protein that immune cells generate to fight invaders. It targets a protein called programmed cell death 1, or PD-1, on the surface of immune T-cells and precursor B-cells, or pro-B cells. Precursor B-cells are immature white blood cells that develop into fully formed B-cells.

PD-1 suppresses the immune system by binding to programmed death-ligand 1, or PD-L1 — another cell surface protein that several cancers overproduce.

By binding with PD-1, REGN 2810 blocks the interaction between PD-1 and PD-L1, promoting T-cell growth and survival. The result is a revved-up immune system that can then attack cancer cells.

REGN2810 in clinical trials

Advanced malignancies

A Phase 1 clinical trial (NCT02383212) evaluated the safety and anti-tumor activity of REGN2810 alone and in combination with other treatments in patients with advanced malignancies, including CSCC.

Researchers looked at three doses of REGN2810 as a stand-alone therapy and two doses combined with radiation. Patients received injections of REGN2810 every two weeks.

Preliminary results on 58 patients with advanced solid tumors showed that the group tolerated REGN2810 well. A key effectiveness finding was that a combination of REGN2810 and radiation shrunk tumors.

In addition, preliminary data on 26 patients with advanced or metastatic CSCC showed that the group tolerated REGN2810 well and that the therapy attacked tumors. Patients received injections of REGN2810 every two weeks for up to 48 weeks.

Regeneron is recruiting patients for a Phase 2 trial (NCT02760498) of REGN2810’s ability to treat adults with metastatic and advanced CSCC. The study is expected to be completed by 2019.

Another Phase 1 trial (NCT03005782) will evaluate whether a combination of REGN2810 and another monoclonal antibody, REGN3767, is an effective treatment for advanced malignancies. Regeneron is recruiting participants for the study in the United States, Australia, and Germany. It is expected to be completed by 2020.

Renal cell carcinoma (RCC)

Regeneron and SillaJen have agreed to collaborate on a Phase 1b trial (NCT03294083) of REGN3767’s ability to treat patients with RCC, the most common type of kidney cancer.

The study will evaluate a combination of REGN2810 and Pexa-Vec, a virus-based vaccine that is designed to attack cancer cells.

Non-small cell lung cancer (NSCLC)

Regeneron is recruiting patients for a Phase 3 trial (NCT03088540) that will look at whether REGN2810 or platinum-based chemotherapy is more effective at treating advanced or metastatic NSCLC.

The study will be conducted in Australia, Bulgaria, Georgia, Russia, and Turkey. It is expected to be completed by 2021.

Cervical cancer

Regeneron is recruiting patients in the United States and Australia for a Phase 3 trial (NCT03257267) of REGN2810’s ability to treat cervical cancer that has returned or spread after failing to respond to platinum-based chemotherapy.

It will compare REGN2810 and a chemo of researchers’ choice.

Basal cell carcinoma (BCC)

A Phase 2 trial (NCT03132636) will assess REGN2810’s ability to fight BCC that is advanced or has spread.

Regeneron is recruiting patients for the study in the United States, and expects to complete it by 2020.

Glioblastoma multiforme (GBM)

Regeneron announced an agreement with Inovio Pharmaceuticals to start a Phase 1b/2a trial that will evaluate how well a combination of REGN2810 and two other therapies can fight newly diagnosed GBM.

One of the other treatments is INO-5401, an immunotherapy that targets several cancer antigens, or molecules that can trigger an immune response. The other treatment is INO-9012, an immunotherapy designed to harness IL-12, a protein that can counter cancer.

The study is expected to begin in late 2017.


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