Serplulimab Plus Bevacizumab Biosimilar Showed Efficacy, Safety Among Patients With Hepatocellular Carcinoma

According to a phase 2 study, the combination of serplulimab, a PD-1 inhibitor, and HLX04, a bevacizumab biosimilar, exhibited promising antitumor activity and a manageable safety profile among patients with previously treated advanced hepatocellular carcinoma.

Zhenggang Ren, MD, Zhongshan Hospital at Fudan University, Shanghai, China, and coauthors wrote, “Given the synergistic effects of antiangiogenesis agents with immune checkpoint blockage, and the [overall survival] benefits seen with atezolizumab plus bevacizumab in the first-line setting, it is postulated that combination therapy with the [2] drug classes may provide clinical benefits in a subsequent-line setting for patients with advanced [hepatocellular carcinoma].” In a phase 1 trial, serplulimab plus HLX04 was well tolerated among patients with advanced or metastatic solid tumors.

This multi-center, open-label, single-arm study enrolled 41 patients with hepatocellular carcinoma who had previously received systemic therapy to either group A (n = 20) or group B (n = 21). In group A, patients received 3 mg/kg serplulimab plus 5 mg/kg HLX04. In group B, patients received 3 mg/kg serplulimab plus 10 mg/kg HLX04. There was a further group C (serplulimab monotherapy) and group D (3 mg/kg serplulimab plus 10 mg/kg HLX04 in the first-line setting), but data on those groups were immature at the time of data cutoff. The primary end points were safety and tolerability. Secondary end points included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR).

The median duration of follow-up was 15.2 month for group A and 12.3 months for group B. The objective response rate was 30.0% in group A and 14.3% in group B. The median duration of response was not reached (95% confidence interval [CI], 3.3 to not evaluable [NE]) in group A and was 9.0 months (95% CI, 7.9 to NE) in group B. The median PFS was 2.2 months and 4.1 months, respectively. The median OS was 11.6 months and 14.3 months respectively. There were 14 patients (70.0%) in group A and 12 patients (57.1%) in group B who experienced grade ≥3 treatment-emergent adverse events. Most immune-related adverse events were grade ≤3.

Dr Ren et al concluded, “serplulimab plus HLX04 has a manageable safety profile and shows antitumor activity in patients with previously treated advanced [hepatocellular carcinoma], which warrants further investigations of this combination therapy for the treatment of [hepatocellular carcinoma] in phase 3 trials.”

Source:

Ren Z, Shao G, Shen J, et al. Phase 2 study of the PD-1 inhibitor serplulimab plus the bevacizumab biosimilar HLX04 in patients with previously treated advanced hepatocellular carcinoma. Liver Cancer. 2023;12(2):116-128. doi:10.1159/000526638