Antiangiogenic Agents in NSCLC Where are we? Which biomarkers? VEGF Is the Only Angiogenic Factor Present Throughout the Tumor Life Cycle

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1 Antiangiogenic Agents in NSCLC Where are we? Which biomarkers? Martin Reck Department e t of Thoracic c Oncology ogy Hospital Grosshansdorf Germany VEGF Is the Only Angiogenic Factor Present Throughout the Tumor Life Cycle VEGF, vascular endothelial growth factor Bergers G, et al. Nat Rev Cancer. 2003;3(6): Jain RK, et al. Nat Clin Pract Oncol. 2006;3(1): Inoue M, et al. Cancer Cell. 2002;1(2):

2 Targets of Antiangiogenic Therapy VEGF Antibodies VEGF Receptor TKI Scappaticci, F. A. J Clin Oncol; 20: Antiangiogenic treatment in NSCLC Anti VEGF antibodies Anti VEGF TKIs and other approaches 2

3 Bevacizumab: First-Line Trials Inclusion N Patients Control Bevacizumab Trial Period Analyzed Randomization Arm Dose AVF-0757g :1:1 Cp, P Arm A: 7.5 mg/kg Arm B: 15 mg/kg ECOG :1 Cp, P 15 mg/kg AVAiL :1:1 Ci, G, Pl (low or high h dose) Arm A: 7.5 mg/kg Arm B: 15 mg/kg JO :1 Cp, P 15 mg/kg 1. Johnson DH, et al. J Clin Oncol. 2004;22: Sandler A, et al. N Engl J Med. 2006;355(24): Reck M, et al. J Clin Oncol. 2009;27(8): Ichinose Y, et al. Eur J Cancer Suppl. 2009;7(2): Abstract O Bevacizumab Metaanalysis OS PFS Soria JC et al, ESMO

4 Bevacizumab Metaanalysis Soria JC et al, ESMO 2010 Antiangiogenic treatment in NSCLC Anti VEGF antibodies Predictive Markers? Anti VEGF TKIs and other approaches 4

5 Individualized Approach Safety Driven? Exclusion criteria: Histology (squamous cell carcinoma) Invasion of central blood vessels History of gross hemoptysis Active, relevant cardiovascular disease ECOG 4599: Survival and Hypertension Dahlberg S et al, J Clin Oncol

6 No correlation between hypertension and bevacizumab efficacy Systematic analysis of HTN and clinical outcome in 5,900 patients across 6 clinical trials of bevacizumab In 5 of the 6 studies, HTN during treatment was not predictive of clinical benefit or prognostic for the course of disease AVF2107g NO16966 AVADO RIBBON-1 AVAiL AVOREN Prognostic HR (p value) for PFS 1.20 (0.14) 1.00 (>0.99) 1.09 (0.66) 1.16 (0.34) 0.95 (0.69) 1.11 (0.45) for OS 1.36 (0.02) 0.89 (0.49) 1.02 (0.95) 1.40 (0.11) 0.85 (0.33) 0.87 (0.45) Predictive HR (p value) for PFS 0.55 (0.0008) 0.81 (0.18) 0.91 (0.72) 0.82 (0.26) 1.04 (0.83) 0.81 (0.29) for OS 0.43 (<0.0001) 0.80 (0.36) 0.91 (0.85) 0.62 (0.05) 1.32 (0.21) 0.98 (0.95) Hurwitz, et al. ASCO 2010 Predictive Markers Antiangiogenic Agents Current Approaches Imaging: PET Dynamic Contrast Enhanced (DCE) MRI Alternative RECIST Criteria Infiltrating Myeloid Cells (Heng, JCO 2009) Circulating Endothelial cells VEGF Polymorphisms Lung?? Circulating Vascular Marker 6

7 BO21015 (ABIGAIL) study design and endpoints Previously untreated, stage IIIB, IV or recurrent nonsquamous NSCLC (n=300) Stratified by stage, gender, PS, chemotherapy regimen Bevacizumab 7.5mg/kg q3w Bevacizumab 7.5mg/kg until progression + up to six 21-day cycles of Carboplatin/Gemcitabine it bi (CG)* PD or Carboplatin/Paclitaxel (CP)* (n=150) No cross-over permitted Bevacizumab 15mg/kg q3w + up to six 21-day cycles of Carboplatin/Gemcitabine (CG)* or Carboplatin/Paclitaxel (CP)* (n=150) PD Bevacizumab 15mg/kg until progression Primary endpoint: exploration of correlation between candidate biomarkers and overall response rate to chemotherapy plus bevacizumab *Chemotherapy regimen was not randomly allocated but was chosen by the Investigator Secondary endpoints: PFS; ORR; DCR; duration of response; OS and safety Key exploratory endpoints: changes in candidate biomarkers across time, correlation of tumour volume changes with RECIST Mok T et al, ESMO 2011 Biomarker evaluable population*: baseline characteristics Characteristic, n (%) Bev 7.5mg + chemo (n=144) Bev 15mg + chemo (n=143) Gender Female 53 (37) 55 (38) Male 91 (63) 88 (62) Ethnicity Caucasian Asian Other Smoking status Never smoker Former smoker Current smoker ECOG PS (85) 22 (15) 0 (0) 49 (34) 54 (38) 40 (28) 52 (36) 92 (64) 122 (85) 20 (14) 1 (<1) 38 (27) 68 (48) 37 (26) 49 (34) 94 (66) Histology Adenocarcinoma 133 (86) 126 (88) Biomarker evaluable population (BEP) represents 95% of ITT population reasons for exclusion: 7 patients did not have a baseline biomarker sample; 9 patients did not receive at least one dose of bevacizumab * all patients who received at least one dose of bevacizumab with a valid baseline plasma sample Mok T et al, ESMO

8 Secondary efficacy outcomes Bev 7.5mg + Bev 15mg + HR chemo chemo (95% CI) (n=151) a (n=140) a ORR (CR+PR), % DCR (CR+PR+SD), % Duration of response, months (n=154)(itt) (n=149)(itt) Median PFS, months b Median OS, months ( ) 1.16 ( ) a Population evaluable for response b final OS analysis (clinical cut off 10 months after PFS analysis, as per protocol) Mok T et al, ESMO 2011 Choice of chemotherapy? Shaked Y et al, Cancer Cell

9 Exploratory analysis of PFS by bevacizumab dose level and chemotherapy regimen * PFS estimate Regimen n Median PFS (months) 6-month PFS rate Bev 15mg/kg g + CP % Bev 7.5mg/kg + CP % Bev 15mg/kg + CG % Bev 7.5mg/kg + CG % CG = carboplatin/gemcitabine; CP = carboplatin/paclitaxel Time (months) *Chemotherapy regimen was not randomly allocated but was chosen by the Investigator. Approximately 60% of patients received CG Mok T et al, ESMO 2011 Challenges (Shaked 2008) Challenging technology (Fresh samples needed) d) Technology not standardized Markers to define CECs/CEPs are in discussion Multiple Factors which contribute to change of CEC/CEP count (timing of VEGF-Inhibitor) 9

10 Primary endpoint: overall response rate relative to baseline candidate biomarker status Low BM level N Responders, % bfgf E-SELECTIN ICAM PLGF VEGFA VEGFR VEGFR High BM level N Responders, % Logistic regression OR* 95% CI P value After adjustment for multiple testing, none of the candidate biomarkers correlated with overall response rate according to baseline plasma level Definition of candidate biomarker (BM) level: low median; high > median; *Odds ratio: high vs low BM level BEP population patients pooled; all patients received bevacizumab; covariates: treatment, biomarker level (dichotomized) and baseline prognostic factors; statistically significant if p (0.05/7 adjusted for multiple testing) Mok T et al, ESMO 2011 Exploratory analysis of PFS relative to candidate biomarker status N Low BM level No. of Median events, n (%) PFS, months bfgf (82) 7.2 E-SELECTIN (84) 6.6 ICAM (83) 7.0 PLGF (84) 6.7 VEGFA (79) 7.4 VEGFR (84) 7.2 VEGFR (84) 6.7 N High BM level No. of Median events, n (%) PFS, months (88) (86) (87) (91) (90) (86) (86) 6.9 Cox regression HR 95% CI P value Lower plasma VEGFA at base line was associated with a longer PFS BEP patients pooled : all patients received bevacizumab. Covariates: treatment, biomarker level (dichotomized) and baseline prognostic factors; statistically significant if p (0.05/7 adjusted for multiple testing) N.B. Absence of control arm precludes determination of predictive and/or prognostic value of the tested BM candidate Mok T et al, ESMO

11 Exploratory analysis of PFS relative to baseline plasma VEGFA levels PFS estimate Biomarker value level: Low (median PFS 7.4m) High (median PFS 6.1m) HR=1.57 ( ) p= No. at risk Time (months) Low High Lower plasma VEGFA at base line was associated with a longer PFS Mok T et al, ESMO 2011 Abigail ongoing research Changes in Candidate Biomarker across time (Dynamic Sampling) Correlation of tumor volume changes with RECIST Analyses of tumor samples Individual Expression profiles 11

12 Antiangiogenic treatment in NSCLC Anti VEGF antibodies Anti VEGF TKIs and other approaches VEGF-TKI First Line Therapy Randomized Phase III trials Reference Schedule Prim EP RR PFS (m) OS (m) Outcome Scagliotti ASCO 2011 Scagliotti J Clin Oncol 2010 Gatzemeier ESMO 2010 Carbo/Pac +/- Motesanib Carbo/Pac +/- Sorafenib OS OS 40% 26% 27.4% 24% (HR 0.79) (HR 0.99) (HR 0.9) (HR 1.15) Cis/Gem /- OS Na Sorafenib (HR 0.83) (HR 0.98) Negative Negative Negative 12

13 Sorafenib + KRAS Mutation? 37 pretreated patients (Second / Third line) 8% Squamous Cell NSCLC K-Ras Mutation Rate: 32% EGFR Mutation Rate: 22% Response: 6% DCR: 65% Kelly RJ et al, Clin Cancer Res 2011; 17: Sorafenib + KRAS Mutation? KRAS Mut + KRAS Mut - PFS (m) 2.6 P:0.51 OS (m) P: 0.59 All Kelly RJ et al, Clin Cancer Res 2011; 17:

14 VEGF-TKI Second Line Therapy Randomized Phase III Trials Reference Schedule Prim EP RR PFS (m) OS (m) Outcome Scagliotti Erlotinib +/- 10.6% OS ESMO 2010 Sunitinib 6.9% Herbst Lancet Oncol 2010 De Boer J Clin Oncol 2011 Natale J Clin Oncol 2011 Novello WCLC 2011 Doce +/- Vancetanib Pem +/- Vandetanib Erlotinib v Vandetanib Doce +/- Aflibercept PFS PFS PFS OS 17% 10% 19.1% 7.9% 12% 12% 23.3% 8.9% (HR 0.8) (HR 0.92) (HR 0.79) (HR 0.98) (HR 0.98) (HR 0.82) (HR 1.0) Negative Positive Negative Negative Negative VITAL Trial: PFS (ITT) 1.0 Symbol=Censor Placebo/Docetaxel 0.9 Aflibercept/Docetaxel Kaplan-Meier Estimate Stratified HR (95%CI) = ( ) 0.937) P = Median PFS: Placebo + docetaxel = 4.11 mos. Aflibercept + docetaxel = 5.19 mos. N Aflibercept + Docetaxel Placebo + Docetaxel RR 23.3% 8.9% P-value < Number at Risk Time (Months) Placebo Afli Cut-off date= Jan 26, 2011;Median follow-up = months WCLC, 07July 2011 Novello et al. J Thorac Oncol 6: 2011 (suppl; abstr O43.06) 14

15 VITAL Trial: Overall survival (ITT) 1.0 Symbol=Censor Placebo/Docetaxel 0.9 Aflibercept/Docetaxel Kaplan-Meier Estimate Stratified HR (95.1%CI) = 1.01 ( ) P = Median OS: Placebo + docetaxel = mos. Aflibercept + docetaxel = mos. 0.1 log-rank p = Number at Risk Time (Months) Placebo Afli Cut-off date= Jan 26, 2011;Median follow-up = months WCLC, 07July 2011 Novello et al. J Thorac Oncol 6: 2011 (suppl; abstr O43.06) BIBF 1120* inhibits VEGFR, PDGFR and FGFR In vitro Potent inhibitor of VEGFR, FGFR and PDGFR in enzymatic and cellular assays VEGFR 1 / 2 / 3 PDGFR α / FGFR 1 / 2 / 3 IC 50 / EC 50 (nm) 34 / 21 / / / 37 / 108 *This is an investigational agent. Its efficacy and safety have not been established Hilberg F, et al. Cancer Res 2008;68:

16 FGFR1 Amplification in Squamous Cell NSCLC Systematic search for genetic alterations in 232 lung cancer specimen 155 Squamous Cell Lung Cancer samples with frequent FGFR1 Amplification Testing of FGFR1 Inhibitor PD in 83 cell lines Weiss J et al, Science Transl Met 2010, BIBF 1120: LUME-Lung study programme LUME-Lung 1 and 2: large, multinational, randomized, double-blind, Phase III, placebo-controlled clinical trials assessing the efficacy of BIBF 1120* 200 mg BID with second-line chemotherapy in patients with advanced or recurrent NSCLC Patients with: histologically or cytologically confirmed NSCLC; stage IIIB/IV or recurrent NSCLC; failure of one previous first-line chemotherapy for advanced and/or metastatic disease; eligibility for docetaxel or pemetrexed therapy BIBF standard docetaxel th Placebo + standard docetaxel th BIBF standard pemetrexed therap Placebo + standard pemetrexed therap therapy therapy therapy therapy Maintenance BIBF 1120 Maintenance placebo Maintenance BIBF 1120 Maintenance placebo 1 o endpoint PFS; 2 o OS, RR, QL, safety LUME-Lung 1 N=1300 fully accrued 1 o endpoint PFS; 2 o OS, RR, QL, safety LUME-Lung 2 N=1300 ongoing *This compound is an investigational agent. Its efficacy and safety have not been established. 16

17 Conclusion Confirmed efficacy of anti VEGF antibody bevacizumab b in eligible ibl patients t Role of VEGF-TKI remains to be defined Further drugs are in clinical investigation Up to now no predictive marker available 17

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