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
183P - Final analysis of phase II clinical study evaluating the safety and effectiveness of neoadjuvant S-1 + oxaliplatin combination therapy for older patients with locally advanced gastric cancer
Presenter: Eiji Oki
Session: Poster Display
Resources:
Abstract
184P - Neutropenia as a predictive and prognostic factor in nanoliposomal-irinotecan/fluorouracil/leucovorin therapy for pancreatic cancer: Findings from the NAPOLEON-2 study (NN-2301)
Presenter: Yuki Sonoda
Session: Poster Display
Resources:
Abstract
185P - Disease etiology impact on outcomes of hepatocellular carcinoma patients treated with atezolizumab plus bevacizumab: A real-world, multicenter study
Presenter: Silvia Foti
Session: Poster Display
Resources:
Abstract
186P - Efficacy and safety of fruquintinib with nab-paclitaxel in advanced G/GEJ cancer after exposure to immune checkpoint inhibitors: A single-center prospective clinical trial
Presenter: Xiaoting Ma
Session: Poster Display
Resources:
Abstract
187P - Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus transhepatic arterial infusion chemotherapy (HAIC) for resectable multinodular CNLC Ib/IIa hepatocellular carcinoma (Car-Hero)
Presenter: Yongguang Wei
Session: Poster Display
Resources:
Abstract
188P - Impact of metformin, statin, aspirin and insulin on the prognosis of unresectable HCC patients receiving first-line lenvatinib or atezolizumab plus bevacizumab
Presenter: Margherita Rimini
Session: Poster Display
Resources:
Abstract
189P - Safety run-in results from LEAP-014: First-line lenvatinib (len) plus pembrolizumab (pembro) and chemotherapy (chemo) for metastatic esophageal squamous cell carcinoma (ESCC)
Presenter: Shun Yamamoto
Session: Poster Display
Resources:
Abstract
190P - Perioperative camrelizumab combined with chemotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: A single-arm, single-center, phase II clinical trial
Presenter: Jiaxing He
Session: Poster Display
Resources:
Abstract
191P - Predictive value of CXCR6 expression in gastric cancer survival and immune modulation
Presenter: Song-Hee han
Session: Poster Display
Resources:
Abstract
192P - Antiangiogenesis-related adverse events (ARAE) to predict efficacy in patients with advanced gastric cancer (AGC) treated with apatinib + chemotherapy: Results from two prospective studies
Presenter: Rongbo Lin
Session: Poster Display
Resources:
Abstract