Abstract 86P
Background
High EGFR expression has been observed in about 50% of advanced cutaneous squamous cell carcinoma (CSCC). EGFR inhibitor is recommended in NCCN guidelines for some later-line patients. However, no EGFR inhibitor has been approved as a first-line option worldwide. This study aimed to evaluate the efficacy and safety of HLX07 (a novel humanised anti-EGFR antibody) monotherapy in patients with advanced CSCC, including first-line patient.
Methods
This single-arm, open-label, multicentre phase 2 study consisted of 2 parts. Part 1 explored the preliminary efficacy and was presented below; part 2 evaluated the efficacy and safety of HLX07 (at a fixed dose based on part 1) in a larger cohort. Patients with advanced CSCC harbouring lymph node or distant metastasis, or locally advanced CSCC that was not amenable to surgery/radical radiation therapy were enrolled to receive intravenous HLX07 at 1500 mg (group A) or 1000 mg (group B), Q3W in part 1. The primary endpoint was independent radiological review committee (IRRC)-assessed objective response rate (ORR) per RECIST 1.1. Secondary endpoints included other efficacy measures, safety, pharmacokinetics, immunogenicity, and quality-of-life assessment.
Results
As of 2 July 2023, 31 patients were enrolled and assigned to group A (n=21) and group B (n=10) in part 1. The median age was 60 years; 16 (51.6%) patients were male. Among the 29 efficacy evaluable patients (21 in group A and 8 in group B), the median follow-up duration was 9.6 months and 3.1 months in the respective groups. IRRC-assessed unconfirmed ORR was 23.8% (95% CI 8.2–47.2) in group A and 62.5% (95% CI 24.5–91.5) in group B. IRRC-assessed median PFS was 3.6 months (95% CI 1.4–5.9) in group A and not reached in group B. Median OS was not reached in either group. Among the 31 patients who received study treatment, grade ≥3 treatment-related adverse events (TRAEs) occurred in 8 (38.1%) and 2 (20.0%) patients in group A and B, respectively, most commonly hypomagnesaemia (14.3% vs. 10.0%) and rash (4.8% vs. 10.0%). No TRAE leading to death was reported.
Conclusions
HLX07 monotherapy demonstrated encouraging antitumour efficacy and was well-tolerated in patients with advanced CSCC.
Clinical trial identification
NCT05238363 (released on 14 February 2022).
Editorial acknowledgement
Editorial assistance was provided by Zhi Hao Kwok, Shiqi Zhong, and Chen Hu of Shanghai Henlius Biotech, Inc.
Legal entity responsible for the study
Shanghai Henlius Biotech, Inc.
Funding
Shanghai Henlius Biotech, Inc.
Disclosure
X. Hu, L. Wang, Q. Wang, J. Zhu: Financial Interests, Personal, Full or part-time Employment: Shanghai Henlius Biotech, Inc. All other authors have declared no conflicts of interest.
Resources from the same session
228P - Real-world data on dose adjustment of cabozantinib in advanced renal cell carcinoma
Presenter: Hemavathi Baskarane
Session: Poster Display
Resources:
Abstract
229P - The application of diffusion kurtosis imaging in predicting muscle invasion of bladder cancer: A comparison with conventional DWI
Presenter: Shuai Jiang
Session: Poster Display
Resources:
Abstract
230P - Oncological outcomes between partial cystectomy and radical cystectomy in solitary muscle invasive bladder cancer with downgraded T stage
Presenter: Ming Wei Hsu
Session: Poster Display
Resources:
Abstract
231P - BMI-predicted progression-free survival after pembrolizumab therapy for urothelial cancer: Asian version of BMI classification is suitable for Asian patients
Presenter: mirii harada
Session: Poster Display
Resources:
Abstract
232P - The immunosuppressive features of the 20S Proteasome β-subunit gene family in von Hippel-Lindau (VHL)-mutated clear cell renal cell carcinoma (ccRCC): A TCGA-based bioinformatics study
Presenter: Saja Alzghoul
Session: Poster Display
Resources:
Abstract
233P - The crosstalk between PBRM1 loss and tumor immune microenvironment (TIME) of clear cell renal cell carcinoma (ccRCC): A possible interconnection to immunotherapy response
Presenter: Ahmed Al Sharie
Session: Poster Display
Resources:
Abstract
235P - Do FGFR2 and 3 proteins have a role in the prognosis of urothelial bladder carcinoma?
Presenter: Alshimaa Al Hanafy
Session: Poster Display
Resources:
Abstract
236P - The effects of chemotherapy on body composition in patients with advanced urothelial carcinoma
Presenter: KOSUKE KITAMURA
Session: Poster Display
Resources:
Abstract
237P - Real-world analysis of adjuvant nivolumab in resected urothelial cancer: A single institute study in Taiwanese patients
Presenter: Mu-Hsin Chang
Session: Poster Display
Resources:
Abstract
238P - Enfortumab-vedotin for metastatic urothelial carcinoma refractory to platinum-based chemotherapy and immune checkpoint inhibitors: A single institution experience
Presenter: Yuki Endo
Session: Poster Display
Resources:
Abstract