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Poster display session

999 - A Dose-Response Study of Ramucirumab Treatment in Patients with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: Primary Results of 4 Dosing Regimens in the Phase 2 Trial I4T-MC-JVDB

Date

09 Sep 2017

Session

Poster display session

Presenters

Jaffer Ajani

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

J.A. Ajani1, A. Udrea2, T. Sarosiek3, M. Shenker4, C. Morgan5, J. Pikiel6, E. Wojcik7, D. Swinson8, M. Joseph9, A. Luft10, T. Salek11, C. Tournigand12, D. Ferry13, Y. Zhang13, A. Long13, W. Kuo13, L. Gao13, J. Kauh13, W. Mansoor14

Author affiliations

  • 1 Md Anderson Cancer Center, University of Texas, 77030 - Houston/US
  • 2 Oncology, MedisProf SRL, Cluj-Napoca/RO
  • 3 Oncology, Magodent, Warszawa/PL
  • 4 Sf. Nectarie Srl, Centrul de Oncologie, Craiova/RO
  • 5 Oncology, Velindre Cancer Centre, Cardiff/GB
  • 6 Oncology, COPERNICUS Podmiot Leczniczy, Gdańsk/PL
  • 7 Oncology, NZOZ Centrum Medyczne HCP, Poznań/PL
  • 8 St James's Institute Of Oncology, St James's University Hospital, Leeds/GB
  • 9 Deanesly Centre, New Cross Hospital, Wolverhamptom/GB
  • 10 Oncology, Leningrad Regional Clinical Hospital, St. Petersburg/RU
  • 11 Oncology, Narodny Onkologicky Ustav, Bratislava/SK
  • 12 Oncology, CHU Henri Mondor, Creteil Cedex/FR
  • 13 Oncology, Eli Lilly and Company, Bridgewater/US
  • 14 Nhs Foundation Trust, Christie Hospital, Manchester/GB
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Resources

Abstract 999

Background

Ramucirumab (RAM) is approved for the treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior platinum and/or fluoropyrimidine chemotherapy at 8 mg/kg every 2 weeks (Q2W) based on results of 2 phase 3 trials. Exposure-response analyses from these trials indicated efficacy of RAM correlated with exposure. JVDB is an open-label RAM monotherapy study that examined pharmacokinetics (PK) and safety of the standard and 3 higher exposure regimens.

Methods

Patients (n = 164) were randomized 1:1:1:1 to 4 treatment arms: 8 mg/kg Q2W (Arm 1), 12 mg/kg Q2W (Arm 2), 6 mg/kg every week (Arm 3), and 8 mg/kg Days 1 and 8 (D1D8) every 3 weeks (Q3W) (Arm 4). PK was collected from all groups. Treatment-emergent adverse events (TEAEs) were graded by NCI CTCAE v4.0. Tumor response was assessed by RECIST 1.1.

Results

Mean RAM trough and peak concentrations are shown (Table). Median (months) progression-free survival (PFS) was similar across all arms (Arm 1=1.45; Arm 3=1.54; Arm 4=1.51), with the exception of Arm 2=2.50. PFS hazard ratio (HR) for Arm 2 vs 1=0.82; Arm 3 vs 1=0.88; Arm 4 vs 1=0.77. Overall survival (OS) HR for Arm 2 vs 1=0.70; Arm 3 vs 1=0.95; Arm 4 vs 1=0.90. The most common TEAEs were fatigue (22.4%), decreased appetite (21.1%), abdominal pain (18%), and vomiting (18%), consistent with the REGARD trial.Table:

698P

Trough (μg/ml)Peak (μg/ml)
ArmRegimenWeek 6Week 12Week 6Week 12
18 mg/kg Q2W (standard)47.664.3189195
212 mg/kg Q2W71.079.4303309
36 mg/kg QW83.0125187226
48 mg/kg D1D8 Q3W57.481.6180210

Conclusions

Trough concentrations of the 3 experimental regimens were greater than the standard regimen. Arm 2 displayed the highest peak RAM concentration. Though efficacy findings were not significant, some trends toward improved PFS and OS versus the standard regimen were observed. Despite higher RAM exposures observed with the alternative regimens, safety profiles were comparable to the standard regimen.

Clinical trial identification

NCT02443883

Legal entity responsible for the study

Eli Lilly and Company

Funding

Eli Lilly and Company

Disclosure

J.A. Ajani: Honoraria: Lilly, Bayer, Novartis, Five Prime Therapeutics, Taiho, Genentech, Celgene Funding: Novartis, BMS, Taiho, Genentech, MedImmune, Amgen, Lilly, Merck, Delta-Fly, Gilead Sciences, Takeda, Celgene. M. Shenker: Corporate-sponsored research, meaning international clinical trials (like JVDB trial), for which I have financial contract as PI: Eli Lilly, Pfizer, Roche, Novartis, BMS, MSD, Merck Serono, Boehringer Ingelheim, Amgen, Astellas, Mylan. C. Tournigand: Honoraria from Eli Lilly. D. Ferry, Y. Zhang, A. Long, W-L. Kuo, L. Gao, J. Kauh: Employee of Eli Lilly. All other authors have declared no conflicts of interest.

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