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
39P - Prognostic significance of hypoxic microenvironment biomarkers in invasive ductal breast cancer
Presenter: Sungmin Kang
Session: Poster Display
Resources:
Abstract
40P - Intra-tumoral CD3, CD4, and CD8 as prognostic biomarkers in Asian breast cancer
Presenter: Jia Wern Pan
Session: Poster Display
Resources:
Abstract
41P - Brown fat activation demonstrated on FDG PET/CT predicts survival outcome
Presenter: Sonya Park
Session: Poster Display
Resources:
Abstract
42P - A promising anticancer drug for triple-negative breast cancer: OZ-001 suppresses tumor growth by dual targeting STAT3 and calcium signaling
Presenter: Jisun Kim
Session: Poster Display
Resources:
Abstract
43P - Performance evaluation of a combined risk model for breast cancer risk prediction in Indonesian population (TRIP Study)
Presenter: Marco Wijaya
Session: Poster Display
Resources:
Abstract
44P - Pathological complete response to neoadjuvant chemotherapy and outcomes in Her-2 negative locally advanced breast cancer
Presenter: Amrith Patel
Session: Poster Display
Resources:
Abstract
45P - Demographic determinants of pathological complete response after neoadjuvant chemotherapy in breast cancer
Presenter: Anvesh Dharanikota
Session: Poster Display
Resources:
Abstract
46P - Predicting toxicity following cancer chemotherapy by detecting transporter gene ABCB1 (C1236T, G2677T/A, C3435CT) polymorphism in breast cancer patients receiving chemotherapy with anthracycline and taxane either sequentially or concomitantly
Presenter: Tanuma Mistry
Session: Poster Display
Resources:
Abstract
47P - Sequencing of chemotherapy and surgery among older triple-negative and HER2-positive breast cancer patients with comorbidities
Presenter: Anvesh Dharanikota
Session: Poster Display
Resources:
Abstract
48P - The impact of preoperative axillary ultrasound on the false negative rate of sentinel lymph node biopsy in post neoadjuvant chemotherapy breast cancer patients
Presenter: Byshetty Rajendar
Session: Poster Display
Resources:
Abstract