From April 17 to 22, the 117th Annual Meeting of the American Association for Cancer Research (AACR) was held in San Diego, USA.As one of the most influential academic events in the global oncology field, the AACR Annual Meeting brings together top experts and scholars worldwide engaged in basic cancer research, clinical research and translational research, serving as a key academic platform for presenting research achievements of innovative anti-cancer drugs globally.The results of the multicenter, open-label Phase I clinical trial (SYS6010-001-NPC) evaluating SYS6010 in the expanded cohort of advanced nasopharyngeal carcinoma were selected for a Plenary Session Oral Presentation. The trial’s Principal Investigator (PI) is Professor Mai Haiqiang from Sun Yat-sen University Cancer Center. Dr. Yang Xiuhao, Senior Medical Director of CSPC Pharmaceutical Group, delivered an oral presentation of the research findings at the conference.
This study aimed to evaluate the safety, tolerability and preliminary antitumor activity of SYS6010 in subjects with advanced solid tumors. Enrolled patients were those with advanced nasopharyngeal carcinoma who had disease progression after receiving ≥1 prior line of therapy (including PD-1 inhibitors and platinum-based chemotherapy). Patients received intravenous infusion of SYS6010 at a dose of 4.2 mg/kg or 4.8 mg/kg once every three weeks until disease progression or the occurrence of intolerable toxicity.The primary endpoints were safety and tolerability; the secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). Subgroup analyses were performed based on prior epidermal growth factor receptor (EGFR) monoclonal antibody treatment and lines of prior therapy.As of September 15, 2025, a total of 56 patients were included in the safety analysis set (34 patients in the 4.2 mg/kg group and 22 patients in the 4.8 mg/kg group).
The median patient age was 49.5 years (range: 27–70 years); males accounted for 83.9% of all patients. In terms of ECOG performance status, 19.6% of patients had a score of 0 and 80.4% had a score of 1. The mean body mass index (BMI) was 22.7±3.34, and 30.4% of patients had previously received EGFR monoclonal antibody therapy.All patients experienced at least one treatment-emergent adverse event (TEAE), and the most common Grade ≥3 TEAEs were hematological toxicities. Overall, SYS6010 demonstrated a favorable and manageable safety profile.The efficacy analysis set comprised 54 patients, with an overall ORR of 31.5%.
The ORR was 28.1% in the 4.2 mg/kg group (including one case of complete response) and 36.4% in the 4.8 mg/kg group; the overall DCR reached 87.0%.
The median progression-free survival (mPFS) was 7.5 months (95% CI: 5.49–8.38), with 7.4 months in the 4.2 mg/kg group and 7.7 months in the 4.8 mg/kg group. The median overall survival (mOS) had not been reached, and the 12-month OS rate was 66.4% (95% CI: 45.01–81.00).Subgroup analyses showed that among patients receiving ≥2 lines of prior therapy without previous EGFR monoclonal antibody treatment, the ORR reached 42.9% in the 4.2 mg/kg group and 50.0% in the 4.8 mg/kg group. A total of 57.1% of patients achieved EBV seroconversion after treatment. The ORR was 31.2% in patients with EBV seroconversion versus 11.1% in those without seroconversion.
About SYS6010
SYS6010 is an independently developed antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR) by CSPC Innovation Pharmaceutical. It consists of a humanized anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker.The drug can specifically bind to EGFR receptors on the surface of tumor cells. After internalization, it releases cytotoxic payloads inside the cells, thereby exerting anti-tumor effects. EGFR is highly expressed in a variety of solid tumors, which endows this class of drugs with broad development prospects.
To date, SYS6010 has been granted Breakthrough Therapy Designation for two indications, namely EGFR-mutant drug-resistant non-small cell lung cancer and esophageal squamous cell carcinoma, by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.In addition, CSPC Innovation Pharmaceutical is concurrently conducting multiple Phase III clinical studies of SYS6010 for a range of solid tumor indications, covering esophageal squamous cell carcinoma, first-line non-small cell lung cancer, second-line non-small cell lung cancer, and second-line and above breast cancer.