Veliparib or pembrolizumab, added to total neoadjuvant therapy (TNT), did not improve short-term outcomes in patients with locally advanced rectal cancer (LARC), the NRG-GI002 trial demonstrated. However, the updated data indicate that pembrolizumab may improve the overall survival of these patients.
“The NRG-GI002 trial (NCT02921256) is designed to seek novel therapeutic options to improve the current TNT in patients with LARC,” said Dr Thomas George (University of Florida, FL, USA). All included patients with very high-risk stage 2 or 3 LARC received 8 cycles of mFOLFOX6 chemotherapy, chemoradiotherapy, and surgery. In the 2 experimental arms, patients were administered to additional veliparib (n=90), during radiotherapy, or pembrolizumab (n=90), starting from the first day of radiotherapy . The primary endpoint was the reduction in the neoadjuvant rectal (NAR) score. Previous results did not reveal a benefit for either one of the experimental arms over the control arm regarding the primary outcome [2,3]. Dr George presented the updated findings.
There was no significant difference between the control arm (mean 12.5) or the veliparib (mean 13.3) arm in terms of the Neoadjuvant Rectal (NAR) score (Log-rank P=0.81)  or any of the other short-term or long-term outcomes. Dr George added that there was a trend towards a worse overall survival (OS) in the veliparib group compared with the control group: 3-year OS (85% vs 92%; HR 2.13; 95% CI 0.86–5.29; P=0.10). Patients in the pembrolizumab arm (mean 11.5) did not demonstrate a significant advantage over the control arm (mean 14.4) in terms of NAR score either (Log-rank P=0.21). The 3-year OS rates, however, suggest that pembrolizumab may deliver a benefit for these patients in the long run (95% vs 87%; HR 0.35; 95% CI 0.12–1.00; Log-rank P=0.04).
“Molecular interrogation of tumour and circulating biomarkers is ongoing to identify subgroups that may benefit from these targeted treatments,” mentioned Dr George at the end of his talk.
- George TJ, et al. Long-term results from NRG-GI002: A phase II clinical trial platform using total neoadjuvant therapy (TNT) in locally advanced rectal cancer (LARC). Abstract 7, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.
- George TJ, et al. JCO. 2019;37(15suppl):abstr 3505.
- Rahma OE, et al. JAMA Oncol. 2021;7(8):1225–1230.
- George Jr TJ, et al. Curr Colorectal Cancer Rep. 2015;11(5):275–280.
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Table of Contents: ASCO GI 2023
Letter from the Editor
ASCO GI 2023 Highlights Podcast
Oesophageal and Gastric Cancer
Zolbetuximab plus mFOLFOX6 successful in CLDN18.2-positive subgroup of gastric cancer
Regorafenib offers survival benefit for patients with pre-treated gastric cancer
Radiotherapy or not in locally advanced oesophageal or junctional cancer?
Neoadjuvant immunotherapy is safe and efficacious in a phase 2 gastric cancer trial
S-1 adjuvant chemotherapy: 4 or 8 courses in stage 2 gastric cancer?
LATG/LAPG demonstrates excellent long-term efficacy in stage 1 gastric cancer
3-year follow-up data confirms benefits of nivolumab plus chemotherapy
Long-term results for nivolumab plus chemotherapy and nivolumab plus ipilimumab in oesophageal cancer
Promising phase 2 results for HER-Vaxx in gastric cancer
Anal and Colorectal Cancer
IMbrave 151 missed primary endpoint in advanced BTC
Combination botensilimab plus balstilimab demonstrates promising activity in heavily pre-treated MSS CRC
Mutation-based selection to identify patients suitable for panitumumab treatment
Fucoidan associated with quality-of-life benefits in patients with rectal cancer receiving CCRT
ctDNA appears useful in monitoring patients with anal cancer undergoing CRT
SUNLIGHT trial meets primary endpoint in refractory metastatic CRC
Does cell-free DNA influence MRD testing in post-operative colon cancer?
OPERA: surgery may be avoided with adequate therapy in rectal cancer
Can we improve total neoadjuvant therapy for rectal cancer?
Palliative radiation therapy improves hepatic pain in HCC and liver metastasis
Improved survival following postoperative sorafenib plus TACE in HCC
Quality-of-life benefits for tislelizumab in uHCC
Stereotactic body radiation therapy beneficial for patients with locally advanced HCC
SWOG 1815, first-ever phase 3 trial in BTC, fails
Acceptable safety profile and encouraging efficacy of nanvuranlat in BTC
First-line NALIRIFOX superior to standard treatment in mPDAC
Novel approach delivers quality-of-life benefits for patients with pancreatic cancer
EMR versus ESD in oesophageal cancer