EC approves Libtayo® for metastatic cervical cancer

The European Commission (EC) has approved Regeneron Pharmaceuticals, Inc.’s Libtayo® (cemiplimab) for adults with recurrent or metastatic cervical cancer and disease progression while on or after platinum-based chemotherapy. The approval is based on Phase III trial results showing 12 months overall median survival (OS) for the overall patient population.

“Libtayo® was the first programmed cell death protein (PD)-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a Phase III trial. With this fourth approval from the EC, Libtayo® can now be extended to appropriate patients in the European Union (EU) with advanced cervical cancer, irrespective of their PD-L1 status or histology,” stated Dr Israel Lowy, PhD, Senior Vice President, Translational and Clinical Sciences of Oncology at Regeneron.

Clinical trial for metastatic cervical cancer

The trial evaluating 350mg of Libtayo® every three weeks in comparison to chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine) enrolled 608 patients across 14 countries. In March 2021, the trial was halted early due to highly significant overall survival (OS) rates in squamous cell carcinoma (SCC) patients.

The study results were published in New England Journal of Medicine, which reported:

  • 31 percent reduction in the risk of death and a longer median OS in the overall population (12 months Libtayo®, 8.5 months chemotherapy; hazard ratio [HR]: 0.69; 95 percent confidence interval [CI]: 0.56 to 0.84; p=0.00011)
  • 27 percent reduction in the risk of death and a longer median OS in patients with SCC histology (11.1 months Libtayo®, 8.8 months chemotherapy; HR: 0.73; 95 percent CI: 0.58 to 0.91; p=0.00306)
  • 25 percent reduction of risk in progressive disease in the overall population (HR: 0.75; 95 percent CI: 0.62 to 0.89; p=0.00048).
  • 16 percent overall response rate (ORR) for Libtayo®, versus 6 percent for chemotherapy in the overall population (95 percent CI: 12.5 to 21.1 vs. 3.8 to 9.6).

Libtayo® clinical trial safety data

Safety was assessed in 1,281 patients with advanced solid malignancies who received Libtayo® monotherapy in five clinical studies. The median duration of exposure to Libtayo® was 28 weeks (range: two days to 144 weeks).

Immune-mediated adverse reactions (ARs) occurred in 21 percent of patients treated with Libtayo® and led to permanent discontinuation in 4.6 percent of patients. The most common immune-mediated ARs were hypothyroidism (6.8 percent), hyperthyroidism (3 percent), immune-mediated pneumonitis (2.6 percent), immune-mediated hepatitis (2.4 percent), immune-mediated colitis (two percent) and immune-mediated skin ARs (1.9 percent). Adverse events (AEs) were serious in 32.4 percent of patients and led to permanent discontinuation in 9.4 percent of patients. The grade 3 or higher AE occurring in >1 percent of patients were anaemia (5.2 percent), hypertension (2.6 percent), fatigue (2.6 percent), urinary tract infection (2.3 percent), hepatitis (1.8 percent), musculoskeletal pain (1.8 percent), rash (1.6 percent) dyspnoea (1.2 percent) and pneumonitis (1.1 percent). No new Libtayo® safety signals were observed.

Professor Ignace Vergote, investigator and gynaecologist oncologist at University Hospitals Leuven in Belgium, Vice-Chair of the Trial Steering Committee described: “Libtayo® is an important advancement for patients with recurrent or metastatic cervical cancer whose disease has progressed following platinum-based chemotherapy and could offer a new standard of care in this setting.”

In addition to the EC’s approval, Libtayo® is authorised in the EU for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).


According to the European Medicines Agency (EMA), Libtayo® is a monoclonal antibody (mAb), a protein that recognises and attaches to programmed cell death protein 1 (PD-1) receptors found on immune T cells. Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, Libtayo® prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.

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