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
111P - Comparison of the efficacy and safety of fruquintinib and fruquintinib combined with immune checkpoint inhibitors in the treatment of metastatic microsatellite stable colorectal cancer: A real-world study
Presenter: Zhiqiang Wang
Session: Poster Display
Resources:
Abstract
112P - Optimal classification and treatment strategy based on technical and oncological futures in recurrence of colorectal liver metastases
Presenter: Kosuke Kobayashi
Session: Poster Display
Resources:
Abstract
113P - Phase I/II study of capecitabine(C)/oxaliplatin(O)/irinotecan(I) combined with bevacizumab(B) in the first-line treatment of metastatic colorectal cancer (mCRC)
Presenter: Kai Ou
Session: Poster Display
Resources:
Abstract
114P - The prognostic role of LAG-3 expression in metastatic colorectal cancer
Presenter: Yi-Hsuan Huang
Session: Poster Display
Resources:
Abstract
115P - Sidedness and survival of chemo-refractory metastatic colorectal cancer treated with lonsurf or regorafenib: A nationwide population-based study in Taiwan
Presenter: Meng-Che Hsieh
Session: Poster Display
Resources:
Abstract
116P - Burden and trends of colorectal cancer in high income Asia Pacific countries from 1990-2019 and its projections of deaths to 2040: A comparative analysis
Presenter: Monika Chhayani
Session: Poster Display
Resources:
Abstract
117P - Australasian real-world treatment selection and clinical outcomes for patients with left side (LS), RAS wildtype (RASwt) metastatic colorectal cancer (mCRC)
Presenter: Vanessa Wong
Session: Poster Display
Resources:
Abstract
119P - Neoadjuvant chemoradiotherapy in the mode of hypofractionation in locally advanced rectal cancer: Is it time to change standards of care?
Presenter: Abror Abdujapparov
Session: Poster Display
Resources:
Abstract
120P - Improved clinical outcomes with cetuximab maintenance therapy in left-sided RAS/BRAF wild-type metastatic colorectal cancer: A real-world study of Hunan cancer hospital
Presenter: Xiaolin Yang
Session: Poster Display
Resources:
Abstract
121P - Single-cell sequencing reveals the role of Treg cells with high expression of BIRC3 in regulating the progression of colorectal cancer
Presenter: Yuqiu Xu
Session: Poster Display
Resources:
Abstract