O-3 Additional data from the KEYNOTE-859 study of pembrolizumab plus chemotherapy versus placebo plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer

Wyrwicz, Lucjan; Oh, Do Youn; Weber, Paul; Bai, Yuxian; Ryu, Min Hee; Lee, J.; Rivera, Fernando; Alves, Gustavo Vasconcelos; Garrido, Marcelo; Shiu, Kai-Keen; Fernandez, M. Gonzalez; Li, Jack; Lowery, M.; Çil, T.; Cruz, Felipe Melo; Qin, Shukui; Liu, Yin; Bordia, Sonal; Bhagia, Pooja; Rha, Sun Young

doi:10.1016/j.annonc.2023.04.018

Cited by 4 publications

(3 citation statements)

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“…These percentages fall below those reported in the CheckMate 649 trial (82.0% for CPS ≥ 1 and 60.4% for CPS ≥ 5) and the KEYNOTE-859 trial (78.2% for CPS ≥ 1 and 34.9% for CPS ≥ 10). 3,8 However, the confirmed ORR in this study surpassed numerically the results of the nivolumab or pembrolizumab plus chemotherapy groups in the CheckMate 649 trial (58%) and the KEYNOTE-859 trial (51.3%). 3,7 A phase 2 study evaluating camrelizumab alongside chemotherapy followed by camrelizumab plus apatinib for untreated advanced gastric cancer reported a confirmed ORR of 58.3%.…”

Section: Discussioncontrasting

confidence: 49%

“…[4][5][6] Furthermore, the KEYNOTE-859 trial demonstrated that the combination of pembrolizumab and chemotherapy led to a statistically significantly enhancement in OS, surpassing placebo alongside chemotherapy, but with a limited survival advantage. 7,8 Current firstline treatments are inadequate, so novel therapies are urgently needed to further improve survival for advanced gastric cancer.…”

Section: Introductionmentioning

confidence: 99%

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First-line camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and chemotherapy for advanced gastric cancer (SPACE): a phase 1 study

Chen,

Xu,

Chen

et al. 2024

Sig Transduct Target Ther

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Patients with advanced gastric cancer typically face a grim prognosis. This phase 1a (dose escalation) and phase 1b (dose expansion) study investigated safety and efficacy of first-line camrelizumab plus apatinib and chemotherapy for advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints included maximum tolerated dose (MTD) in phase 1a and objective response rate (ORR) across phase 1a and 1b. Phase 1a tested three dose regimens of camrelizumab, apatinib, oxaliplatin, and S-1. Dose regimen 1: camrelizumab 200 mg on day 1, apatinib 250 mg every other day, oxaliplatin 100 mg/m² on day 1, and S-1 40 mg twice a day on days 1–14. Dose regimen 2: same as dose regimen 1, but oxaliplatin 130 mg/m². Dose regimen 3: same as dose regimen 2, but apatinib 250 mg daily. Thirty-four patients were included (9 in phase 1a, 25 in phase 1b). No dose-limiting toxicities occurred so no MTD was identified. Dose 3 was set for the recommended phase 2 doses and administered in phase 1b. The confirmed ORR was 76.5% (95% CI 58.8–89.3). The median progression-free survival was 8.4 months (95% CI 5.9-not evaluable [NE]), and the median overall survival (OS) was not mature (11.6-NE). Ten patients underwent surgery after treatment and the multidisciplinary team evaluation. Among 24 patients without surgery, the median OS was 19.6 months (7.8-NE). Eighteen patients (52.9%) developed grade ≥ 3 treatment-emergent adverse events. Camrelizumab plus apatinib and chemotherapy showed favorable clinical outcomes and manageable safety for untreated advanced gastric cancer (ChiCTR2000034109).

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Section: Discussioncontrasting

confidence: 49%

Section: Introductionmentioning

confidence: 99%

First-line camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and chemotherapy for advanced gastric cancer (SPACE): a phase 1 study

Chen,

Xu,

Chen

et al. 2024

Sig Transduct Target Ther

View full text Add to dashboard Cite

show abstract

“…On 24th of November, the EMA approved first-line pembrolizumab with chemotherapy for HER2-negative mGC/GEJC expressing PD-L1 CPS ≥1 based on the results of the KEYNOTE-859 trial [19,20]. and thus expanded the indication of ICI from PD-L1 CPS ≥5 (CheckMate 649) to PD-L1 CPS ≥1.…”

Section: Her2 Negative Disease Gemstone-303 and Rationale-305mentioning

confidence: 99%