COOL - Community in Oncology On Lung Cancer www.esanum.it/cool

1. www.esanum.it/cool
Giaccone G. The potential of antiangiogenic therapy in non-small cell lung cancer. Clin Cancer Res. 2007 Apr
1;13(7):1961-70.
Angiogenesis inhibitors in clinical development for NSCLC :
approaches to targeting VEGF or VEGFRs

2. www.esanum.it/cool
s-s
VEGF- B167
VEGF- B186
PlGF- 1,2
VEGF- A121
VEGF- A145
VEGF- A165
VEGF- A189
VEGF- A206
VEGF- C
VEGF- D
VEGFR1
(Flt-1)
VEGFR2
(Flk-1/KDR)
VEGFR3
(Flt-4)
NRP-1
s-s
NRP-2
IMC-1121B
Vasculogenesis
Angiogenesis
Angiogenesis
Lymphangiogenesis
Ramucirumab (IMC-1121B), a fully human
IgG1 monoclonal antibody, targets VEGFR2
www.researchvegf.com
Youssoufian H, Hicklin DJ, Rowinsky EK. Review: monoclonal antibodies to the vascular endothelial growth factor receptor-2 in cancer therapy. Clin Cancer Res. 2007 Sep 15;13(18 Pt
2):5544s-5548s.

3. www.esanum.it/cool
Studies of ramucirumab in NSCLC
Ongoing trials
Study ID Ph Eligibility/Line Arm(s) N (projected)
NCT00735696 II
Stage IIIB or IV (AJCC
6th ed.), first line
 IMC-1121B + paclitaxel +
carboplatin
40
NCT01160744 II Stage IV , first line
 IMC-1121B + Premetrexed +
Carboplatin or Cisplatin
 Premetrexed + Carboplatin or
Cisplatin
 IMC-1121B + Gemcitabine +
Carboplatin or Cisplatin
 Gemcitabine + Carboplatin or
Cisplatin
280
NCT01168973 III Stage IV, second line
 Docetaxel + Ramucirumab
 Docetaxel + Placebo
1156
www.clinicaltrials.gov (accessed on Aug 28th
, 2010)

4. www.esanum.it/cool
NCT00735696 - Phase 2 study in NSCLC
(1st
-line: IMC-1121B + paclitaxel/carboplatin)
Preliminary results shown at ASCO 2010
Camidge et al. ASCO (Poster) June 2010
D. R. Camidge, M. S. Ballas, S. Dubey, M. Haigentz, P. J. Rosen, J. F. Spicer, H. J. West, G. D. Shah, H. Youssoufian, A. C. Mita. A
phase II, open-label study of ramucirumab (IMC-1121B), an IgG1 fully human monoclonal antibody (MAb) targeting VEGFR-2, in
combination with paclitaxel and carboplatin as first-line therapy in patients (pts) with stage IIIb/IV non-small cell lung cancer
(NSCLC). J Clin Oncol 28:15s, 2010 (suppl; abstr 7588)
Patient Characteristics (n=35)
Gender: male 35% , female 65%
Performance Status: ECOG 0 38% , ECOG 1 62%
Histology: adenocarcinoma w focal squamous 3%, adenocarcinoma97%
Ramucirumab-related AEs in at Least 10% of Pts Across All Grades (N=35)

5. www.esanum.it/cool
Waterfall Plot of Percent Change of Target Lesions
from Baseline per RECIST v1.0 (from 28 pts*)
Response by RECIST
v1.0 (N=29 evaluable
pts)
NCT00735696 - Phase 2 study in NSCLC
(1st
-line: IMC-1121B + paclitaxel/carboplatin)
Preliminary results shown at ASCO 2010 (cont’d)
Camidge et al. ASCO (Poster) June 2010
D. R. Camidge, M. S. Ballas, S. Dubey, M. Haigentz, P. J. Rosen, J. F. Spicer, H. J. West, G. D. Shah, H. Youssoufian, A. C. Mita. A
phase II, open-label study of ramucirumab (IMC-1121B), an IgG1 fully human monoclonal antibody (MAb) targeting VEGFR-2, in
combination with paclitaxel and carboplatin as first-line therapy in patients (pts) with stage IIIb/IV non-small cell lung cancer
(NSCLC). J Clin Oncol 28:15s, 2010 (suppl; abstr 7588)
♦ This pt had PD based on a new lesion
♠These 2 pts had an unconfirmed PR because confirmatory scans have not yet been
performed
* This plot was based on 28 pts with evaluable target lesions. There was 1 pt who had
no follow-up target lesion measurements that were available in the clinical database
and therefore is not presented in this plot; however, the Investigator considered the pt
as SD at the time of this report.

6. www.esanum.it/cool
•NSCLC stage IV progressing during or
after one prior first-line platinum-based
chemotherapy with or without
maintenance therapy
•All histologies
•ECOG PS <=1
R
A
N
D
O
M
I
Z
E
Docetaxel 75 mg/m2
q3w +
IMC-1121B 10 mg/kg q3w Treat until
PD,
toxicity,
consent
withdrawal
2
1
Docetaxel 75 mg/m2
q3w +
Placebo
Randomized Phase 3 Study in NSCLC
Docetaxel +/- IMC-1121B
www.clinicaltrials.gov ; NCT01168973; accessed on Aug 28th
, 2010

7. www.esanum.it/cool