Multicenter phase 1 trial of first-line pyrotinib plus camrelizumab and chemotherapy for HER2-positive advanced G/GEJ-adenocarcinoma

Dr. Liangjun Zhu

Pyrotinib is an irreversible pan-HER inhibitor. A multicenter phase 1 trial in China evaluated first-line pyrotinib in combination with camrelizumab (anti-PD-1) and oxaliplatin-capecitabine chemotherapy for HER2-positive advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma. After phase 1a pyrotinib 320 mg daily was chosen as recommended phase 2 dose. Among 41 patients, 20 patients (48.8%) developed grade 3 or 4 treatment-emergent adverse events, and 4 patients (9.8%) had any grade serious adverse events. Among 27 patients who received the RP2D confirmed complete response and partial response were seen in 2 and 19 patients, respectively (confirmed ORR 77.8%; 95% CI 57.7-91.4). Twelve-month progression-free and overall survival rates were 67.0% and 86.4%, respectively. The authors conclude that pyrotinib plus camrelizumab and chemotherapy showed promising efficacy in the first-line treatment of advanced HER2-positive G/GEJ cancer, without new safety signals.