In short
Serplulimab is an investigational monoclonal antibody being studied for limited-stage small cell lung cancer (LS-SCLC). One authorised Phase 3 trial (NCT05353257) is evaluating serplulimab with chemotherapy and radiotherapy in 500 patients. Serplulimab is also authorised in the EU as Hetronifly for other conditions.
Key points
- Serplulimab is a monoclonal antibody, a type of immunotherapy.
- It is being tested in limited-stage small cell lung cancer (LS-SCLC).
- The trial is Phase 3, the most advanced stage of testing before approval.
- 500 participants are planned to take part.
- The trial measures overall survival and progression-free survival.
- Serplulimab is already authorised in the EU under the name Hetronifly.
What is serplulimab?
Serplulimab is a monoclonal antibody, a laboratory-made protein designed to target a specific molecule in the body. It is an immunotherapy, meaning it works by helping the immune system fight disease. Serplulimab is also known by the development code HLX10 and the trade name Hetronifly. It is authorised as a medicine in the European Union under the name Hetronifly, with the marketing authorisation holder Accord Healthcare S.L.U. The authorisation was granted on 6 February 2025. In the clinical trial described here, serplulimab is being investigated for an additional use in limited-stage small cell lung cancer.
How does serplulimab work?
Serplulimab is a monoclonal antibody that targets PD-1, a protein found on immune cells called T cells. By blocking PD-1, serplulimab helps the immune system recognise and attack cancer cells. The exact mechanism described in the provided sources is limited; however, the source from the European Medicines Agency confirms serplulimab is a monoclonal antibody product.
Which conditions is serplulimab used or studied for?
- Limited-stage small cell lung cancer (LS-SCLC): A fast-growing type of lung cancer that is confined to one side of the chest and can be treated with radiation. The current Phase 3 trial is studying serplulimab in this condition.
- Other conditions: Serplulimab is authorised in the EU as Hetronifly, but the sources provided do not list the specific authorised indications.
How is serplulimab given?
In the clinical trial, serplulimab is given by intravenous use, meaning it is infused into a vein. The dose used in the trial is 300 mg. The product information for the authorised medicine Hetronifly would provide details on the approved dosing schedule, but this is not included in the provided sources.
What do the clinical trials show?
One Phase 3 trial is evaluating serplulimab in limited-stage small cell lung cancer. The trial is currently authorised, meaning it has received approval to proceed. It plans to enrol 500 participants.
The trial compares serplulimab plus chemotherapy and radiotherapy against placebo plus chemotherapy and radiotherapy. The main outcomes measured are overall survival (how long participants live) and progression-free survival (how long they live without the cancer getting worse), assessed using RECIST v1.1 criteria by a blinded independent central review.
Participants are patients with limited-stage small cell lung cancer at stages I to III according to the AJCC 8th edition cancer staging system.
What side effects are known?
The provided sources do not contain a list of side effects for serplulimab. The European Medicines Agency assessment report and the Paul-Ehrlich-Institut page do not describe specific adverse reactions in the excerpts provided.