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Combination of GT90001 and nivolumab in patients with advanced hepatocellular carcinoma: a multicenter, single-arm,
Chiun Hsu1,2, Yi-Fang Chang3, Chia-Jui Yen4
1Department of Medical Oncology, National Taiwan University Cancer Center, No. 57, Ln. 155, Sec. 3, Keelung Road., Da'an Dist., Taipei, 106, Taiwan. hsuchiun@ntu.edu.tw.
Background:
GT90001 (also known as PF-03446962) is an anti-ALK-1 monoclonal antibody and has shown activity in hepatocellular carcinoma (HCC). This phase 1b/2 study was designed to determine the recommended phase 2 dose (RP2D) of GT90001 plus nivolumab, and assess the safety and anti-tumor activity in patients with advanced HCC.
Methods:
Patients with advanced HCC were recruited from 3 centers. Eligible patients in the dose de-escalation stage received the GT90001 on day 1 of a 14-day cycle in a rolling-six design with a fixed dose of nivolumab (3.0 mg/kg). Patients in dose-expansion stage received the RP2D of GT90001 plus nivolumab. Primary endpoint was safety. Key secondary endpoint was objective response rate (ORR) as per RECIST 1.1.
Results:
Between July 9, 2019, and August 8, 2022, 20 patients were treated (6 in phase 1b; 14 in phase 2) and evaluable for analysis. In phase 1b, no dose-limiting toxicities were observed, and GT90001 7.0 mg/kg was confirmed as the RP2D. Common grade 3/4 adverse events (AEs) were platelet count decreased (15%). No deaths due to AEs were reported. Confirmed ORR and disease control rate were 30% (95% CI, 14.6%-51.9%) and 40% (95% CI, 21.9%-61.3%), respectively. Median duration of response was not calculated (95% CI, 7.39 months to not calculated). Median progression-free survival (PFS) was 2.81 months (95% CI, 1.71-9.33), with 6-month and 12-month PFS rates of 35% and 25%, respectively. One patient with multiple intra- and extra-hepatic metastases was diagnosed with pseudo-progression upon GT90001 plus nivolumab exposure.
Conclusions:
GT90001 plus nivolumab has a manageable safety profile and promising anti-tumor activity in patients with advanced HCC.
Trial Registration Number:
ClinicalTrials.gov identifier NCT03893695.
Insights
This study found that GT90001 (an anti-ALK-1 antibody) combined with nivolumab shows promising anti-tumor activity and a manageable safety profile in advanced hepatocellular carcinoma (HCC) patients.
Area of Science:
- Oncology
- Immunotherapy
- Hepatocellular Carcinoma Research
Background:
- GT90001, an anti-ALK-1 monoclonal antibody, demonstrated activity in hepatocellular carcinoma (HCC).
- Advanced HCC remains a significant clinical challenge requiring novel therapeutic strategies.
Purpose of the Study:
- To determine the recommended phase 2 dose (RP2D) of GT90001 in combination with nivolumab.
- To assess the safety and anti-tumor activity of this combination in patients with advanced HCC.
Main Methods:
- A phase 1b/2 study enrolled patients with advanced HCC across three centers.
- Dose de-escalation and expansion phases were conducted using a rolling-six design with GT90001 and fixed-dose nivolumab.
- Safety and objective response rate (ORR) per RECIST 1.1 were primary and key secondary endpoints, respectively.
Main Results:
- GT90001 at 7.0 mg/kg was established as the RP2D, with no dose-limiting toxicities observed.
- The confirmed ORR was 30% (95% CI, 14.6%-51.9%), with a disease control rate of 40%.
- Median progression-free survival (PFS) was 2.81 months; 6-month and 12-month PFS rates were 35% and 25%, respectively. One case of pseudo-progression was noted.
Conclusions:
- The combination of GT90001 and nivolumab exhibits a manageable safety profile in advanced HCC.
- Promising anti-tumor activity was observed, supporting further investigation of this therapeutic combination.
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