Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial
| العنوان: | Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial |
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| المؤلفون: | Andres O. Soriano, Nicolas Penel, Hendrik-Tobias Arkenau, Lars Zender, Ling Gao, Rafael Santana-Davila, Joana M Oliveira, Roy S. Herbst, Jennifer L. Cultrera, Ian Chau, Samuel McNeely, Johanna C. Bendell, Christophe Le Tourneau, Emiliano Calvo, Charles S. Fuchs, David Ferry, Gu Mi |
| المصدر: | Cancers, Vol 12, Iss 2985, p 2985 (2020) Cancers Volume 12 Issue 10 |
| بيانات النشر: | MDPI AG, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, ramucirumab, Pembrolizumab, lcsh:RC254-282, Article, Ramucirumab, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Clinical endpoint, 030212 general & internal medicine, phase 1b, Adverse effect, Antitumor activity, business.industry, Cancer, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, gastric/gastroesophageal junction adenocarcinoma, Tolerability, 030220 oncology & carcinogenesis, Adenocarcinoma, pembrolizumab, business |
| الوصف: | Ramucirumab (anti-VEGFR2) plus pembrolizumab (anti-PD1) demonstrated promising antitumor activity and tolerability among patients with previously treated advanced cancers, supporting growing evidence that combination therapies modulating the tumor microenvironment may expand the spectrum of patients who respond to checkpoint inhibitors. Here we present the results of this combination in first-line patients with metastatic G/GEJ cancer. Twenty-eight patients (&ge 18 years) with no prior systemic chemotherapy in the advanced/metastatic setting received ramucirumab (8 mg/kg days 1 and 8) plus pembrolizumab (200 mg day 1) every 3 weeks as part of JVDF phase 1a/b study. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). Tumors were PD-L1-positive (combined positive score &ge 1) in 19 and -negative in 6 patients. Eighteen patients experienced grade 3 treatment-related adverse events, most commonly hypertension (14%) and elevated alanine/aspartate aminotransferase (11% each), with no grade 4 or 5 reported. The ORR was 25% (PD-L1-positive, 32% PD-L1-negative, 17%) with duration of response not reached. PFS was 5.6 months (PD-L1-positive, 8.6 months PD-L1-negative, 4.3 months), and OS 14.6 months (PD-L1-positive, 17.3 months PD-L1-negative, 11.3 months). Acknowledging study design limitations, ramucirumab plus pembrolizumab had encouraging durable clinical activity with no unexpected toxicities in treatment-naï ve biomarker-unselected metastatic G/GEJ cancer, and improved outcomes in patients with PD-L1-positive tumors. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2072-6694 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5ffc75b4bca7c81599a1b7dd280b0e2 https://www.mdpi.com/2072-6694/12/10/2985 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....e5ffc75b4bca7c81599a1b7dd280b0e2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20726694 |
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