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
280P - Radium-223 for patients with metastatic castration-resistant prostate cancer with symptomatic bone metastases progressing after first-line abiraterone or enzalutamide: One institutional experience
Presenter: Keng Man Chiang
Session: Poster Display
Resources:
Abstract
281P - 10-year treatment outcome of prostate cancer patients with 3D conformal radiation: Experience of a single cancer institution in Iran
Presenter: Reyhane Bayani
Session: Poster Display
Resources:
Abstract
282P - Predictors of outcomes in patients with clinically lymph node-positive prostate cancer after definitive radiotherapy
Presenter: Jae-Sung Kim
Session: Poster Display
Resources:
Abstract
283P - Radiotherapy utilization rate and treatment patern of protate cancer at Cipto Mangunkusumo Central General Hospital (RSCM): What we learn from pre-pandemic era
Presenter: Riyan Apriantoni
Session: Poster Display
Resources:
Abstract
284TiP - CYCLONE 3: A phase III, randomized, double-blind, placebo-controlled study of abemaciclib in combination with abiraterone plus prednisone in men with high-risk metastatic hormone-sensitive prostate cancer
Presenter: Nobuaki Matsubara
Session: Poster Display
Resources:
Abstract
292P - Comparative characteristics of early cervical cancer diagnosis methods for Tashkent women
Presenter: Gulnoza Goyibova
Session: Poster Display
Resources:
Abstract
293P - Carboplatin in locally advanced cervical cancer treated with chemoradiation: An alternative to cisplatin
Presenter: Natalia Isabel Valdiviezo Lama
Session: Poster Display
Resources:
Abstract
294P - Concurrent chemoradiation with cisplatin every 3 weeks in locally advanced cervical cancer: A single arm phase II clinical trial
Presenter: Long Nguyen
Session: Poster Display
Resources:
Abstract
295P - A prospective study of dose escalated simultaneous integrated boost in node-positive cervical cancer
Presenter: Ritusha Mishra
Session: Poster Display
Resources:
Abstract
296P - Safety, efficacy, and immunogenicity of therapeutic vaccines for patients with high-grade cervical intraepithelial neoplasia (CIN 2/3) associated with human papillomavirus: A systematic review
Presenter: Caroline Amélia Gonçalves
Session: Poster Display
Resources:
Abstract