Sanofi and Regeneron’s Libtayo has gained its first approval in Europe, becoming the sixth PD-1/PD-L1 inhibitor to reach the market.
The immunotherapy has gained approval for use adult patients with cutaneous squamous cell carnimona (CSCC), one of the most commonly diagnosed skin cancers globally.
Cases of the skin cancer are increasing in certain European countries, there is little on the market for those suffering with advanced stages of the disease.
Libtayo is the first treatment approved in the EU for patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation, and follows US approval granted in September last year.
Sanofi and Regeneron believe that by launching the first immunotherapy treatment for the condition, they can get a foothold in the market, away from the intense competition from established rivals in other tumour types.
The European approval is based on data from the phase 2 trial EMPOWER-CSCC-1 study, and is also supported by two advanced CSCC expansion cohorts from an additional phase 1 trial.
The approval is conditional on the addition of a new patient group to the EMPOWER-CSCC-1 phase 2 trial, which will need to further support the benefit-risk profile of the drug. The results of this will then be reported to the EMA, and as is standard practice, the regulator will also review any additional information annually.
Beyond the ongoing EMPOWER-CSCC-1 trial, Libtayo is also being investigated in adjuvant and neoadjuvant trials in CSCC and in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer.
These trials show the marketing partners taking on existing checkpoint inhibitor treatments on established indications, where proving additional value will prove a much more difficult task.
Sanofi and Regeneron aren’t holding back on the scale of their research programme, and these include trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma.
These trials are designed to investigate Libtayo across a range of settings, monotherapy and in combination with chemotherapy and novel agents including vaccines, oncolytic viruses and bispecific antibodies and others.
The companies will be banking on one these combinations producing sufficiently strong results to help them break at least some of these lucrative therapy areas.
Nevertheless, analysts don’t see Libatyo making a big impression in the field: Evaluate Pharma forecasts the drug reaching revenues of just $600 million by 2024, a similar level to Pfizer and Merck’s Bavencio, and far behind MSD’s class leader Keytruda, expected to hit $14.5bn that year.