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
49P - Survival outcomes of HER2-positive breast cancer patients treated with neoadjuvant therapy at a single cancer centre in India
Presenter: Minit Shah
Session: Poster Display
Resources:
Abstract
50P - A nationwide retrospective cohort study of the response to neoadjuvant chemotherapy between HER-2 low and HER-2 negative non-metastatic breast cancer in Qatar: A real-world analysis
Presenter: Ahmed Kardousha
Session: Poster Display
Resources:
Abstract
51P - Four-year outcomes of hypofractionated postmastectomy radiation therapy of 39 Gy in 13 fractionations
Presenter: Sevinj Gahramanova
Session: Poster Display
Resources:
Abstract
52P - A comparative study to assess volumetric and dosimetric profile of heart and lung in patients undergoing left sided post mastectomy radiotherapy: Continuous positive airway pressure (CPAP) versus free breathing (FB) techniques
Presenter: Pritanjali Singh
Session: Poster Display
Resources:
Abstract
29P - HUWE1 inhibition has tumor suppressive effect in triple-negative breast cancer cell lines by modulating glycolytic and immune modulatory markers
Presenter: Shruti Kahol
Session: Poster Display
Resources:
Abstract
53P - Radiotherapy utilization rate for breast cancer in Indonesia: A call for empowering cancer care
Presenter: Donald Manuain
Session: Poster Display
Resources:
Abstract
58P - Safety and pharmacokinetics (PK) of vepdegestrant in Japanese patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer: Results from a Japanese phase I study
Presenter: Hiroji Iwata
Session: Poster Display
Resources:
Abstract
59P - Comprehensive genomic profiling (CGP) unravels druggable targets in breast carcinoma (BC): A single institutional experience
Presenter: Gautam Balaram
Session: Poster Display
Resources:
Abstract
60P - A study of gene alterations in Asian patients with late stage and recurrent breast cancer
Presenter: Po-Sheng Yang
Session: Poster Display
Resources:
Abstract
61P - Tumor cell-released autophagosomes (TRAPs) remodel the breast tumor microenvironment by inducing the formation of inflammatory cancer-associated fibroblasts (CAFs)
Presenter: Chengdong Wu
Session: Poster Display
Resources:
Abstract