Abstract 145P
Background
Perioperative immunotherapy has become a new standard of care in resectable locally advanced NSCLC. However, the optimal neoadjuvant and adjuvant treatment are unknown. Angiogenesis inhibitors have been reported to adjust tumor microenvironment and synergistic effects of immunotherapy. Here, we present updated efficacy and safety data of Penpulimab-based combination neoadjuvant/adjuvant therapy for this population in ALTER-L043.
Methods
Patients (pts) with resectable stage IIB-IIIB (N2) NSCLC, without driver gene mutations, 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
A total of 90 pts were randomized to Arm A (n=30) or Arm B (n=30) or Arm C (n=30). At data cutoff on Sep 30, 2024, median follow-up was 12.8 months. Definitive surgery rates in Arm A/B/C were 62.5% vs 89.7% vs 70.0% respectively. The MPR rates of intention to treat (ITT) population were 76.0% vs 57.7% vs 52.4% in the three arms, and 52.0% vs 50.0% vs 38.1% pts showed pCR respectively. ORR of neoadjuvant therapy was 77.8% vs 58.6% vs 63.3% in the three arms. The incidence of grade ≥ 3 adverse events (AEs) were 46.7% vs 36.7% vs 13.3% 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.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
7P - ACOX2 disturbs the stability of MRE11-RAD50-NBS1 complex and shapes activated immune tumor microenvironment in clear cell renal cell carcinoma
Presenter: Shiqi Ye
Session: Poster Display session
Resources:
Abstract
9P - CXCR6+PD-1- Tissue Resident memory T cells are associated with poor prognosis in patients with metastatic colorectal cancer
Presenter: Emilien Laloy
Session: Poster Display session
Resources:
Abstract
10P - Tumor-infiltrating lymphocytes and tertiary lymphoid structures in oral cavity squamous cell carcinoma in non-smokers and non-drinkers: Predict clinical outcome
Presenter: Israa Laklouk
Session: Poster Display session
Resources:
Abstract
11P - Tumor-infiltrating lymphocytes on routine H&E staining with automated quantification predict outcomes in resectable non-small cell lung cancer
Presenter: Guus Heuvel
Session: Poster Display session
Resources:
Abstract
12P - Epithelial-mesenchymal transition facilitates response to AXL/PD-1 inhibition in relapsed mesothelioma
Presenter: Essa Baitei
Session: Poster Display session
Resources:
Abstract
14P - Integrated genomic analysis of whole genomes to derive a biomarker of durable response to immunotherapy in melanoma
Presenter: Irene Lobon
Session: Poster Display session
Resources:
Abstract
15P - Verteporfin might potentiate the effects of anti-PD-1 therapy in melanoma-bearing mice model
Presenter: Szonja Kovács
Session: Poster Display session
Resources:
Abstract
16P - Immune checkpoint blockade and HLA-related epistasis in melanoma: Genetic determinants of response and toxicity
Presenter: Martin Little
Session: Poster Display session
Resources:
Abstract
17P - Identification PD-L1-associated lncRNA biomarkers for immunoregulation in ovarian cancer
Presenter: Hee Jung Kim
Session: Poster Display session
Resources:
Abstract
19P - Genetic profiling of early triple-negative breast cancer patients with an indication for neoadjuvant pembrolizumab
Presenter: Bogdan Popescu
Session: Poster Display session
Resources:
Abstract