CSPC PHARMA (01093.HK): SYS6090 monotherapy Phase I/II data in advanced solid tumours out, HCC ORR at 40.0%

NewTimeSpace News: CSPC PHARMA (01093.HK) announced that the results of the first-in-human Phase I/II clinical study of SYS6090 (JMT108), a bifunctional fusion protein targeting programmed death receptor 1 (PD-1) and interleukin-15 (IL-15) developed by the Group, in patients with advanced solid tumours were presented in a rapid oral presentation (abstract No. 1009RO) at the 2026 Congress of the European Society for Medical Oncology (ESMO) on 25 October 2026, with Professor Lin Rongbo of Fujian Provincial Cancer Hospital presenting on behalf of the study team. The presentation highlighted preliminary efficacy and safety data in patients with hepatocellular carcinoma (HCC) and colorectal cancer (CRC), and reported partial responses observed in other tumour types including non-small cell lung cancer (NSCLC).

According to the announcement, the open-label, multicentre Phase I/II study had a data cut-off date of 13 April 2026. In terms of efficacy, 13 patients were enrolled in the HCC cohort, of whom 76.9% (10/13) had received at least second-line prior therapy, 92.3% (12/13) had received prior immunotherapy and 92.3% were at Barcelona Clinic Liver Cancer (BCLC) stage C; 10 patients were included in the efficacy analysis set, with an objective response rate (ORR) of 40.0% (4/10; 95% confidence interval: 12.2–73.8), while patients with prior immunotherapy (n=9) had an ORR of 33.3%. The CRC cohort enrolled 38 patients, of whom 89.5% (34/38) had received at least second-line prior therapy and 73.7% (28/38) had liver metastases; 19 patients were evaluable, with an ORR of 21.1% (4/19), and patients with liver metastases (n=17) had an ORR of 23.5%. The NSCLC cohort enrolled 13 patients, with four achieving partial response and an ORR of over 30.0%; partial responses were also observed in small cell lung cancer, melanoma, renal cell carcinoma, breast cancer and gynaecological tumours.

Safety data were based on 51 patients in the HCC and CRC cohorts. The incidence of any-grade treatment-emergent adverse events (TEAEs) was 86.3% (44/51), grade ≥3 treatment-related adverse events (TRAEs) 17.6% (9/51), serious TRAEs 9.8% (5/51), permanent discontinuation due to TRAEs 2.0% (1/51) and immune-related adverse events 33.3% (17/51); common TEAEs included hypoalbuminaemia, anaemia and elevated liver enzymes, with one TEAE leading to death which was assessed as not treatment-related and no unexpected safety signals observed. The product is a recombinant fully human anti-PD-1 asymmetric bispecific Fc fusion protein incorporating IL-15, with a mutated IgG1 subtype to attenuate Fc-mediated immune functions. The study concluded that the ORR of 40.0% and 21.1% in evaluable HCC and CRC patients supports further evaluation of the product in CRC, HCC and other tumour types, and patient enrolment in the Phase II expansion cohorts is progressing well.