Abstract 542P
Background
Adding PD-L1/PD-1 inhibitors to chemotherapy (chemo) has demonstrated efficacy and been approved for advanced squamous non-small cell lung cancer (sqNSCLC) as first-line therapy. However, the prognosis remains unsatisfactory. High expression of the epidermal growth factor receptor (EGFR) is prevalent in sqNSCLC. This study aimed to compare the efficacy of HLX07, a novel humanised anti-EGFR antibody, plus serplulimab (anti-PD-1 antibody) ± chemo versus serplulimab plus chemo as first-line option for advanced sqNSCLC.
Methods
This randomised, multicentre phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemo. Part 3 explored the preliminary efficacy of the three-drug combination and is presented below. Patients with stage IIIB/IIIC or IV sqNSCLC that could not be treated with surgery or radiation therapy and had not received prior systemic therapy were enrolled and randomised 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), combined with serplulimab (300 mg) and chemo (carboplatin and nab-paclitaxel), Q3W. The primary endpoints were IRRC-assessed ORR and PFS per RECIST 1.1.
Results
As of 27 June 2023, 12 patients were enrolled and randomly assigned to group A (n=6) and group B (n=6) in part 3. The median age was 64 years. 11 (91.7%) patients were male. 10 (83.3%) patients had stage IV disease. With a median follow-up of 3.5 months, investigator-assessed unconfirmed ORR per RECIST 1.1 was 83.3% (95% CI 35.9–99.6) in group A and 66.7% (95% CI 22.3–95.7) in group B. Disease control rate was 100.0% (95% CI 54.1–100.0) in both groups. 2 (33.3%) patients in group A and 1 (16.7%) in group B had serious treatment-emergent adverse events (TEAEs). 1 (16.7%) patient in group B reported a grade 3 adverse event of special interest (AESI) with dermatitis acneiform; no grade 4–5 AESI occurred. No TEAE leading to death was reported.
Conclusions
First-line HLX07 plus serplulimab and chemo conferred encouraging antitumour efficacy with a manageable safety profile in patients with advanced sqNSCLC and warrants further investigation.
Clinical trial identification
NCT04976647 (released on 26 July 2021).
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
J. Feng, L. Wang, J. Li, 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
551P - Real-world incidence and outcomes of immune-related adverse events in NSCLC patients
Presenter: Andrea Knox
Session: Poster Display
Resources:
Abstract
552P - TROPION-Lung05: Datopotamab deruxtecan (Dato-DXd) in Asian patients (pts) with previously treated non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGAs)
Presenter: Yasushi Goto
Session: Poster Display
Resources:
Abstract
553P - Preceding plasma EGFR vs upfront tissue NGS for advanced NSCLC in the Chinese population: A single centre experience in Hong Kong
Presenter: Janet Du
Session: Poster Display
Resources:
Abstract
554P - Comparison of the analytical performance of endobronchial ultrasound-guided transbronchial needle aspiration and other sampling methods for the Oncomine Dx target test: An observational study
Presenter: Kazuhito Miyazaki
Session: Poster Display
Resources:
Abstract
555P - Quality of life in patients with stage IV non-small cell lung cancer and the influence of druggable mutations over time: A prospective, territory-wide study in Hong Kong
Presenter: Jason C S Ho
Session: Poster Display
Resources:
Abstract
556P - Results from the phase I study on efficacy and safety of iruplinalkib (WX-0593) for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) patients who received prior second-generation ALK tyrosine kinase inhibitors (TKIs)
Presenter: xuezhi Hao
Session: Poster Display
Resources:
Abstract
557P - Longitudinal plasma proteomic profiling of EML4-ALK positive lung cancer receiving ALK-TKIs therapy
Presenter: Shasha Wang
Session: Poster Display
Resources:
Abstract
558P - Treatment duration and adherence of brigatinib as second-line treatment after crizotinib for ALK+ NSCLC in South Korea
Presenter: Jeong Eun Lee
Session: Poster Display
Resources:
Abstract
559P - Comprehensive survey of AACR GENIE database revealed a wide range of TMB distribution among all three classes (I, II, III) of BRAF mutated NSCLC
Presenter: Zhaohui Arter
Session: Poster Display
Resources:
Abstract
560P - Triple-targeted therapy of dabrafenib, trametinib and osimertinib for the treatment of acquired BRAF V600E mutation after progression on EGFR-TKIs in advanced EGFR-mutant NSCLC
Presenter: Chengdi Weng
Session: Poster Display
Resources:
Abstract