Sanofi's Libtayo Lands In EU With Skin Cancer Nod
Executive Summary
Nine months after the US approval, the EU has followed suit and given a conditional approval for Sanofi and Regeneron’s IO Libtayo for a, so far, untreatable skin cancer.
Regeneron Pharmaceuticals Inc. and Sanofi’s PD-1 inhibitor Libtayo (cemiplimab) has been given the nod by the European Medicines Agency, making it the first treatment available in Europe for adults with advanced cutaneous squamous cell carcinoma (CSCC) who cannot have surgery or radiation treatment.
Already approved in the US since September 2018, the EU approval was based on data from the pivotal EMPOWER-CSCC-1 trial, which along with two advanced CSCC expansion cohorts from a Phase I trial, provide the largest prospective clinical data set to date to evaluate a systemic therapy in patients with advanced CSCC. (Also see "Sanofi/Regeneron's IO Springboard Libtayo Cleared For Skin Cancer " - Scrip, 28 Sep, 2018.)
The conditional approval recognizes the extreme unmet need in advanced CSCC. As part of the conditional approval, Sanofi and Regeneron will add a new patient group to EMPOWER-CSCC-1 to further support the benefit-risk profile of Libtayo, and report the results to the EMA. The EMA will review any new information at least every year and update product labelling as necessary.
Libtayo’s current recommended dose is 350mg IV infusion every three weeks. Treatment may be continued until disease progression or unacceptable toxicity.
Although CSCC is the second most common form of skin cancer, accounting for about 20% of all skin cancer cases, the therapy approvals in the US and EU are for patients who are not candidates for curative surgery or radiation. Approximately 95% of CSCC patients are effectively managed with surgery, greatly reducing the number of treatable patients.
“With no competition in this indication, Libtayo has shown a strong initial launch in the US, with $27m in sales in Q1 2019,” said Michael Ramirez, analyst at Datamonior Healthcare. “[Leerink analyst Geoffrey] Porges has estimated global sales of $1.4bn in 2021, with $600m of that total coming from US sales,” he said. In addition to the US and EU, Libtayo is also currently approved in Canada and Brazil.
Advanced CSCC includes both patients with locally advanced disease, where the cancer cannot be cured by surgery and/or radiation, and patients with metastatic disease. Patients with advanced CSCC have a life expectancy of approximately one year.
UK Pricing
The UK’s The National Institute for Health and Care Excellence (NICE) has recommended cemiplimab to be available within the Cancer Drugs Fund.
In the UK, it is estimated that around 560 people per year with locally advanced or metastatic cutaneous squamous cell carcinoma in adults, where curative surgery or curative radiotherapy is not appropriate, are eligible for treatment with cemiplimab.
The list price of cemiplimab is £4,650 per 350mg vial (1 treatment cycle). The list price for one year of treatment with cemiplimab is £80,877.
“Although there is significant uncertainty around the evidence for cemiplimab, the committee noted that the overall response rates reported in the trials are very promising,” NICE said in a statement.
John Stewart, NHS England’s director of specialized commissioning, said: “NHS England has worked closely with Sanofi and NICE to reach a deal to make this hugely promising innovative drug available, meaning NHS patients in England will be among the first in Europe to benefit.”
Other Indications
Libtayo is also in Phase III trials for cervical and non-small cell lung cancer, in Phase II trials for basal cell carcinoma, brain and prostate cancer, and Phase I trials for hematologic cancer, melanoma, renal cell cancer and solid tumors.
“While approvals for use in NSCLC and cervical cancer certainly have the potential to drive growth for the drug, Libtayo will be met with significant competition in these areas,” said Ramirez. Merck & Co. Inc.’s Keytruda (pembrolizumab) has been approved for second-line use in cervical cancer for over a year and enjoys substantial physician familiarity in multiple indications.
Four PD-1/PD-L1 inhibitors are currently approved for NSCLC. However, Ramirez told Scrip that if positive results were obtained for the three ongoing Phase III trials, particularly the trial comparing Libtayo combinations to Keytruda monotherapy in first-line NSCLC patients with PD-L1 expression ≥ 50%, the drug could compete despite its late market entry. This trial is among the first head-to-head trials between PD-1/PD-L1 inhibitors. “Jorge Insuasty of Sanofi has previously disclosed that he believes Libtayo has the opportunity to be positioned third among the PD-1/PD-L1 inhibitors in NSCLC, behind Keytruda and Opdivo,” Ramirez concluded.