A longer interval between infusions and the option of shorter administration times are at the centre of a proposed update to cemiplimab treatment in Europe.
Regeneron announced on October 16 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended an alternative dosing schedule across all six approved European Union indications. The recommendation would extend dosing intervals from three to six weeks after the first 12 weeks of treatment. newsroom.regeneron.com
What the proposed cemiplimab schedule would change
Under the recommended regimen, patients would receive 350 mg every three weeks for the first 12 weeks, followed by 700 mg every six weeks. Each infusion under this schedule would take 30 minutes.
The CHMP also supported a 15- to 30-minute infusion option for patients receiving 350 mg every three weeks, provided their first 30-minute infusion was well tolerated. This could reduce infusion time by up to half. newsroom.regeneron.com
Extending an option already used in adjuvant skin cancer treatment
The EU already permits the switch to six-weekly dosing after 12 weeks for adults receiving adjuvant cemiplimab for cutaneous squamous cell carcinoma at high risk of recurrence following surgery and radiation.
In this setting, treatment is given after local therapy to reduce the likelihood of cancer returning. According to the EMA, adjuvant cemiplimab can be administered for a maximum of 48 weeks. European Medicines Agency (EMA)
Six indications across skin, lung and cervical cancers
Cemiplimab’s European authorisations cover several distinct treatment settings:
- Cutaneous squamous cell carcinoma: advanced disease unsuitable for curative surgery or radiation, and adjuvant treatment for patients at high risk of recurrence.
- Basal cell carcinoma: locally advanced or metastatic disease following progression on, or intolerance to, a hedgehog pathway inhibitor.
- Non-small cell lung cancer: first-line treatment alone or with platinum-based chemotherapy, subject to PD-L1 expression and molecular eligibility criteria.
- Cervical cancer: recurrent or metastatic disease that has progressed during or after platinum-based chemotherapy. European Medicines Agency (EMA)
Cemiplimab is a monoclonal antibody targeting PD-1 on T cells. Blocking this receptor prevents cancer-associated signals from suppressing T-cell activity, helping the immune system attack cancer cells. European Medicines Agency (EMA)
Evidence supporting the dosing update
Regeneron said the recommendation is supported by pharmacokinetic and pharmacodynamic modelling and simulations, integrated with clinical safety and efficacy data from the cemiplimab development programme.
The European Commission’s final decision is expected in the coming months. If approved, the alternative schedule would become available across all six EU-approved indications.
Read further on OncoDaily: FDA Approves Cemiplimab for Adjuvant Treatment of High-Risk Cutaneous SCC
