LBA52 Sintilimab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First results of the phase III ORIENT-15 study

Immune-Checkpoint Inhibition in the Treatment of Gastro-Esophageal Cancer: A Closer Look at the Emerging Evidence

“…In contrast to KEYNOTE-590, ESCORT-1 and CHECKMATE-648 SCC studies, benefit was observed across all CPS groups including lower PD-L1 expressing tumors. The promising results of this study also demonstrated another potential role for sintilimab for first-line treatment of advanced or metastatic esoSCC [ 49 ].…”

“…In this NeoAegis study, with a median follow up of 24.5 months, the second futility analysis reported 143 deaths including 70 and 73 deaths in the CROSS and MAGIC arms, respectively. In the CROSS and MAGIC arms, the 3-year estimated survival probabilities were 56% (95% CI 47-64) and 57% (95% CI [48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65], respectively (HR 1.02; 95% CI 0.74-1.42). Considering that data were notable for non-inferiority, the DSMB recommended closure of recruitment in December 2020 [62].…”

“…Another notable study that evaluated the efficacy and safety of sintilimab plus chemotherapy versus chemotherapy as first-line treatment in Asian patients (about 97%) with unresectable locally advanced, recurrent or metastatic esoSCC is ORIENT-15 [ 49 ]. A total of 659 patients were randomized to receive sintilimab ( n = 327) versus placebo ( n = 332) plus chemotherapy with cisplatin and 5FU or cisplatin and paclitaxel.…”

Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial

“… 14 Beyond these preclinical observations, several phase III clinical trials have evaluated the added benefit of combining immunotherapy and chemotherapy in the first-line setting for ESCC patients. According to recently released results, 22 , 23 , 24 , 25 , 26 chemoimmunotherapy combinations using TP regimen appear to confer better survival than using 5-FU and cisplatin regimen, indicating that TP regimen could generate a more favorable tumor microenvironment to maximize the immunotherapy or targeted therapy efficacy and might be more suitable for combination. Notably, evidence from clinical studies of head and neck squamous cell carcinoma also supported the combination of cetuximab and the TP regimen, reporting a slightly longer time to treatment failure (TTF) and improved safety profile with a taxane versus 5-FU in combination with anti-EGFR antibody and platinum.…”

ESMO Congress 2021: highlights from the EORTC gastrointestinal tract cancer group’s perspective

“…Additionally, in two randomized, first-line phase III trials conducted in China (Orient-15 5 and Orient-16 6 ), the combination of sintilimab (anti-PD-1) plus chemotherapy demonstrated significant survival benefits compared with chemotherapy alone in metastatic/advanced patients with oesophageal squamous cell carcinoma (Orient-15, PD-L1 CPS ≥10, 17.2 months versus 13.6 months; P = 0.0018 and all patients, 16.7 months versus 12.5 months; P < 0.0001) and adenocarcinoma (Orient-16, PD-L1 CPS ≥5, 18.4 months versus 12.9 months; P = 0.0023 and all patients, 15.2 months versus 12.3 months; P = 0.009).…”