Abstract 492P
Background
The Perioperative combinations including immune checkpoint inhibitors (ICIs) have shown encouraging results in patients with resectable locally advanced NSCLC, but the better treatment option needs to be explored further. Anti-angiogenesis therapy has been reported to adjust tumor microenvironment and synergistic effects of immunotherapy. We made an advanced design to investigate the efficacy and safety of Penpulimab-based combination neoadjuvant/adjuvant therapy for this population.
Methods
In this multicenter phase II study, eligible patients (pts) without driver gene mutations, resectable clinical stage IIB-IIIB (N2) NSCLC, were randomized 1:1:1 to receive one of the three regimens in 21-day cycle: Penpulimab (200mg, iv, day 1) + chemotherapy + Anlotinib (12mg, po, day 1-14) (Arm A) or Penpulimab (200mg, iv, day 1) + chemotherapy (Arm B) or Penpulimab (200mg, iv, day 1) + Anlotinib (12mg, po, day 1-14) (Arm C) for 3-4 cycles before surgery, followed by adjuvant therapy of Penpulimab + Anlotinib (Arm A, C) or Penpulimab monotherapy (Arm B) for a year at most. Primary endpoint was major pathological response (MPR) rate, secondary endpoints were objective response rate (ORR), pathologic complete response (pCR), event-free survival (EFS), 1 year EFS rate, overall survival (OS) and safety.
Results
From December, 2021 to August, 2023, 49 pts were randomized to Arm A (n=16) or Arm B (n=16) or Arm C (n=17). At data cutoff (Aug 3, 2023), median follow-up was 5.3 months. Definitive surgery rates in Arm A/B/C were 87.5% vs 87.5% vs 76.5% respectively. The MPR rates were 70.0% vs 37.5% vs 80% in the three arms, and 50.0% vs 37.5% vs 60% pts showed pCR respectively. ORR of neoadjuvant therapy was 50.0% vs 37.5% vs 47.06% in the three arms. The incidence of grade ≥ 3 adverse events (AEs) were 31.25% vs 31.25% vs 23.53% respectively. There is no fatal AE related to Penpulimab or Anlotinib.
Conclusions
The results demonstrated that these new perioperative combinations of ICI and Anti-angiogenesis agent (Penpulimab and Anlotinib) with or without chemotherapy showed promising efficacy and with manageable safety profiles.
Clinical trial identification
NCT04846634.
Editorial acknowledgement
Legal entity responsible for the study
Tianjin Medical University Cancer Institute & Hospital.
Funding
Has not received any funding.
Disclosure
All 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