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Ref Type Journal Article
PMID (31142504)
Authors Harding JJ, Zhu AX, Bauer TM, Choueiri TK, Drilon A, Voss MH, Fuchs CS, Abou-Alfa GK, Wijayawardana SR, Wang XA, Moser BA, Uruñuela A, Wacheck V, Bendell JC
Title A Phase Ib/II Study of Ramucirumab in Combination with Emibetuzumab in Patients with Advanced Cancer.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol 25
Issue 17
Date 2019 Sep 01
URL
Abstract Text Inhibition of the VEGFR-2 blocks angiogenesis and attenuates tumor growth, but cancers may evade this effect through activation of the hepatocyte growth factor receptor MET. Here we report results of the phase Ib/II study of ramucirumab, a monoclonal anti-VEGFR-2 antibody, plus the anti-MET mAb emibetuzumab.A 3+3 dose escalation of emibetuzumab plus ramucirumab (phase Ib) was followed by tumor-specific expansion cohorts. Primary objectives were to determine the recommended phase II dose and to evaluate antitumor activity. Secondary objectives included safety, pharmacokinetics, and immunogenicity. Tumoral MET expression was explored by immunohistochemistry (IHC).A total of 97 patients with solid tumor [6 phase Ib, 16 gastric or gastroesophageal junction adenocarcinoma, 45 hepatocellular carcinoma (HCC), 15 renal cell carcinoma, and 15 non-small lung cancer] received emibetuzumab at 750 or 2,000 mg flat dosing plus ramucirumab at 8 mg/kg every 2 weeks. No dose-limiting toxicities were observed. Common adverse events were primarily mild or moderate and included fatigue (36.1%), peripheral edema (28.9%), and nausea (14.4%). Emibetuzumab exposures were similar as in previous studies with no apparent drug-drug interactions. Five partial responses (5.2%) were observed across all tumor types. The greatest antitumor activity was noted in HCC with a 6.7% overall response rate, 60% disease control rate, and 5.42 months (95% confidence interval, 1.64-8.12) progression-free survival (PFS). HCC with high MET expression showed improved PFS with approximately 3-fold increase in PFS (8.1 vs. 2.8 months) relative to low MET expression.Ramucirumab plus emibetuzumab was safe and exhibited cytostatic antitumor activity. MET expression may help to select patients benefitting most from this combination treatment in select tumor types.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown lung non-small cell carcinoma not applicable Emibetuzumab + Ramucirumab Phase Ib/II Actionable In a Phase Ib/II trial, Emibetuzumab (LY2875358) and Cyramza (ramucirumab) combination treatment resulted in an objective response rate of 7% (1/15) and a disease control rate of 87% (13/15) in patients with non-small cell lung cancer, with a median progression-free survival of 6.6 months (PMID: 31142504; NCT02082210). 31142504
Unknown unknown Advanced Solid Tumor not applicable Emibetuzumab + Ramucirumab Phase Ib/II Actionable In a Phase Ib/II trial, Emibetuzumab (LY2875358) and Cyramza (ramucirumab) combination treatment demonstrated safety, resulted in an objective response rate of 5.2% (5/97, 5 partial response) and a disease control rate of 62% (60/97) in patients with advanced solid tumors (PMID: 31142504; NCT02082210). 31142504
Unknown unknown renal cell carcinoma not applicable Emibetuzumab + Ramucirumab Phase Ib/II Actionable In a Phase Ib/II trial, Emibetuzumab (LY2875358) and Cyramza (ramucirumab) combination treatment resulted in an objective response rate of 0% and a disease control rate of 47% (7/15) in patients with renal cell carcinoma, with a median progression-free survival of 2.9 months (PMID: 31142504; NCT02082210). 31142504
Unknown unknown gastroesophageal cancer not applicable Emibetuzumab + Ramucirumab Phase Ib/II Actionable In a Phase Ib/II trial, Emibetuzumab (LY2875358) and Cyramza (ramucirumab) combination treatment resulted in an objective response rate of 6% (1/16) and a disease control rate of 50% (8/16) in patients with gastroesophageal cancer, with a median progression-free survival of 1.6 months (PMID: 31142504; NCT02082210). 31142504