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
270P - Germline BRCA1/2 pathogenic variants in Japanese patients with prostate cancer are predictive factors for androgen receptor-axis-targeted therapy or chemotherapy for castration-resistant prostate cancer
Presenter: Shigekatsu Maekawa
Session: Poster Display
Resources:
Abstract
271P - Prostate cancer with histone modifier UTX mutations can benefit from olaparib
Presenter: NOBUHITO MURAMOTO
Session: Poster Display
Resources:
Abstract
272P - Comparison between MRI-targeted and standard biopsy for prostate cancer detection: A systematic review and meta-analysis
Presenter: Andree Kurniawan
Session: Poster Display
Resources:
Abstract
273P - The diagnostic performance of cognitive MRI-targeted biopsy in biopsy-naïve patients undergoing systematic 14-region 18-core biopsy: Do the three areas affect the results?
Presenter: Yuka Toyama
Session: Poster Display
Resources:
Abstract
274P - Index tumor location influencing early biochemical recurrence after radical prostatectomy in patients with negative surgical margins
Presenter: Jun Akatsuka
Session: Poster Display
Resources:
Abstract
275P - Prognosis of metastatic castration-resistant prostate cancer in response to chemotherapy and PSMA expression in circulating tumor cells
Presenter: Naoya Nagaya
Session: Poster Display
Resources:
Abstract
276P - Prognostic significance of p53 mutation in metastatic hormone-sensitive prostate cancer
Presenter: Lakshmi Kamala
Session: Poster Display
Resources:
Abstract
277P - Vasohibin-1 expression as a biomarker of aggressive growth in prostate ductal adenocarcinoma
Presenter: Murad Salomov
Session: Poster Display
Resources:
Abstract
278P - Full-coverage radiotherapy for prostate cancer patients with oligometastases
Presenter: Bichun Xu
Session: Poster Display
Resources:
Abstract
279P - Hypofractionated radiotherapy protocol implementation and early outcomes for prostate cancer patients: A single institution retrospective review
Presenter: Thu Nguyen
Session: Poster Display
Resources:
Abstract