Phase 3 Study of First-Line Serplulimab/Chemotherapy Meets Primary End Point in ES-SCLC

Treatment with serplulimab yielded a significant improvement in overall survival in combination with chemotherapy in patients with previously untreated extensive-stage small cell lung cancer.

A phase 3 (NCT04063163) clinical study assessing the use of first-line PD-1 inhibitor serplulimab plus chemotherapy in a population of patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC) met its primary end point, according to a press release from developer Henlius.

Findings from the interim analysis conducted via independent data monitoring committee indicated that the combination yielded a significant improvement in overall survival, meeting the trial’s predefined efficacy criteria. Moreover, serplulimab and chemotherapy were found to have a positive safety profile, with no reports of new safety signals.

“SCLC is a type of lung cancer with strong invasion and poor prognosis, among which ES-SCLC cancer cells are prone to metastasis. At present, ES-SCLC is mainly treated with chemotherapy or chemotherapy combined with PD-L1 inhibitors. It is easy to progress after chemotherapy, and the 5-year survival rate is generally less than 5%. The prognosis has not been improved for a long time. The results of the phase 3 trial of serplulimab bring a new option for anti-PD-1 [monoclonal antibody] as a first-line ES-SCLC therapy,” independent data monitoring committee chairman Jie Wang, PhD, an assistant professor of oncology in the Department of Biostatistics and Bioinformatics at Roswell Park Comprehensive Cancer Center, said in a press release.

The double-blind multicenter trial had an estimated enrollment of 567 patients who were randomized to receive a combination of serplulimab plus carboplatin and etoposide or the chemotherapy backbone alone.

To be eligible for the study, patients had to have histologically or cytologically confirmed ES-SCLC and received no prior treatments. Adequate major organ function was also required. Patients who were known to have any history of severe allergy to monoclonal antibodies, had a hypersensitivity to carboplatin or etoposide, or who were pregnant or breast feeding were ineligible for the trial. Other exclusion criteria included those with a history of psychotropic drug abuse or addiction, and other factors that could lead to early trial termination based on investigator’s judgement.

“There are limited choices for SCLC clinical treatment, especially in anti–PD-1 monoclonal antibodies. This international multi-center phase 3 clinical study on ES-SCLC has been carried out in many countries in Asia and Europe, with more than 580 subjects worldwide. By means of multi-center clinical data, we hope serplulimab will enter the international market and benefit more patients worldwide,” Giorgio Vittorio Scagliotti, MD, PhD, chief of the Medical Oncology Division at the S. Luigi Hospital in Orbassano; the head of the Department of Oncology; and a professor of oncology at the University of Torino, concluded.


Henlius' Phase 3 clinical study of novel PD-1 inhibitor serplulimab for the treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) meets primary study endpoint. News release. Henlius. December 7, 2021. Accessed December 7, 2021.

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