Abstract 145P
Background
Implementation of preoperative CRT in patients (pts) with locally advanced R-ESCC is suboptimal for many reasons, including safety concerns. PET/CT scanning has shown positive predictive data and may help optimize neoadjuvant treatment in R-ESCC. We report the primary analysis of an ongoing, phase 2, multicenter study conducted in China, which investigated the efficacy and safety of PET/CT-guided neoadjuvant treatment with TIS, an anti-programmed cell death protein 1 antibody, plus Chemo/CRT in R-ESCC (NCT04974047).
Methods
Therapy-naïve adult pts with AJCC 8th Ed. Stage cT1-2N+M0 or cT3NanyM0 R-ESCC received a PET/CT scan at baseline (BL), then one cycle of induction Chemo (cisplatin-paclitaxel [Cis-Pac]), and another PET/CT scan 15-21 days later. Pts were categorized into two cohorts per response to induction Chemo, based on the decrease from BL in PET maximum standardized uptake value in the primary tumor (responders [R]: ≥35%, nonresponders [NR]: <35%). Both cohorts received three cycles of TIS 200 mg IV + two cycles of Chemo (Cis-Pac) Q3W for R or two cycles of CRT (investigator-chosen Cis-Pac or Cis-5-FU + radiotherapy [40 Grays in 20 fractions]) for NR. Pts then underwent surgery. The primary endpoint was postresection pathological complete response (pCR) rate; secondary endpoints included R0 resection rate and safety (adverse events [AEs]).
Results
Of 70 pts enrolled, 15 (21%) and 48 (69%) had stage II and III disease at BL, respectively. Thirty pts were R and 40 were NR to induction Chemo. Of the R, 21 (70%) had undergone surgery; the pCR rate was 29% (n=6; 95% CI: 11, 52); the R0 resection rate was 95%. Of the NR, 33 (83%) had undergone surgery; the pCR rate was 33% (n=11; 95% CI: 18, 52); the R0 resection rate was 91%. Fourteen pts (47%) in the R cohort and 33 pts (83%) in the NR cohort had ≥grade 3 treatment-related AEs (TRAEs); AEs leading to treatment discontinuation occurred in one pt (3%) and four pts (10%), respectively. No pts had surgery canceled due to AEs. No TRAEs leading to death were reported.
Conclusions
As neoadjuvant treatment in pts with R-ESCC, TIS + Chemo/CRT demonstrated promising pCR rates and tolerable safety in both R and NR (PET/CT-assessed).
Clinical trial identification
NCT04974047, first posted July 23, 2021.
Editorial acknowledgement
This study was sponsored by BeiGene, Ltd. Medical writing support, under direction of the authors, was provided by Ghina Yaacoub, MSc, of Ashfield MedComms, an Inizio company, and was funded by BeiGene, Ltd.
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
L. Chen, Y. Liao, T. Jiang, M. Kang, X. Mei, L. Tan, J. Liu, H. Jiang: Non-Financial Interests, Institutional, Principal Investigator: BeiGene. Z. Zhang, W. Yu: Financial Interests, Personal, Full or part-time Employment: BeiGene. L. Li: Financial Interests, Personal, Full or part-time Employment: BeiGene (Beijing) Co., Ltd; Financial Interests, Personal, Stocks/Shares: BeiGene (Beijing) Co., Ltd; Financial Interests, Personal, Training: BeiGene (Beijing) Co., Ltd.
Resources from the same session
592P - Treatment patterns and outcomes in patients with advanced non-small cell lung cancer with MET exon 14 skipping alterations in China
Presenter: Hanxiao Chen
Session: Poster Display
Resources:
Abstract
593P - MET TKIs in Asian patients (pts) with MET exon 14 skipping NSCLC: A matching-adjusted indirect comparison (MAIC)
Presenter: E-e Ke
Session: Poster Display
Resources:
Abstract
594P - The treatment pattern and clinical outcome in NSCLC patients with MET alteration: A retrospective real-world analysis in China
Presenter: Yongfeng Yu
Session: Poster Display
Resources:
Abstract
595P - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Presenter: Koichi Goto
Session: Poster Display
Resources:
Abstract
596P - Repotrectinib in patients (pts) from Asia and China with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC): Results from the phase I/II TRIDENT-1 trial
Presenter: Ross Soo
Session: Poster Display
Resources:
Abstract
597TiP - A phase I/II study to evaluate the safety and anti-tumor activity of JIN-A02 in patients with EGFR TKI-refractory, EGFR-mutant advanced NSCLC
Presenter: Sun Min Lim
Session: Poster Display
Resources:
Abstract
598TiP - Exploration of aumolertinib in first-line treatment for advanced non-small cell lung cancer patients of performance status 3 with EGFR mutations (19del and L858R)
Presenter: Haiyi Deng
Session: Poster Display
Resources:
Abstract
599TiP - A prospective study of savolitinib plus docetaxel in pretreated EGFR/ALK/ROS1/METex14m-wildtype advanced NSCLC patients with MET overexpression (FirstMET)
Presenter: Shuting Zhan
Session: Poster Display
Resources:
Abstract
600TiP - Phase III study of telisotuzumab vedotin (Teliso-V) vs docetaxel in pretreated c-Met overexpressing EGFR wildtype (WT) non-squamous (NSQ) locally advanced/metastatic non-small cell lung cancer (a/mNSCLC)
Presenter: Junko Tanizaki
Session: Poster Display
Resources:
Abstract
601P - Pembrolizumab in patients of Chinese descent with microsatellite instability-high/mismatch repair deficient advanced solid tumors: KEYNOTE-158
Presenter: Xiaohua Wu
Session: Poster Display
Resources:
Abstract