Ganetespib and Docetaxel in NSCLC

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1 Ganetespib and Docetaxel in NSCLC Suresh S. Ramalingam, MD Associate Professor Director, Division of Medical Oncology Emory University Winship Cancer Institute 1

2 Role of Docetaxel in Advanced NSCLC Docetaxel has been approved by the FDA for first-line and salvage therapy of patients with advanced NSCLC It is effective against all histological sub-types of NSCLC It has also demonstrated efficacy in the maintenance therapy setting In refractory NSCLC, docetaxel provides modest survival benefit Response rate < 10% Median PFS- 3 months Median survival 6-8 months An efficacy plateau has been reached in salvage therapy of NSCLC with currently available agents 2

3 Hsp90 Regulates Multiple Hallmarks of Cancer 3

4 Rationale For Targeting Hsp90 in NSCLC Lower gene expression of HSP90 correlates with improved Survival in NSCLC PLoS One Mar 5;3(3):e Integration of gene dosage and gene expression in non-small cell lung cancer, identification of HSP90 as potential target. 4

5 Comparison of Ganetespib with 17-AAG STA-9090 has better potency compared to 17AAG in Hsp90 binding and lung cancer cell growth inhibition. (A) 120 Hsp90 binding FP assay (B) well viability assay (A549 cells) % of Control 60 0 STA-9090 IC 50 : 3.9 nm 17AAG IC 50 : 21.0 nm % of Control STA-9090 IC 50 : 13.3 nm 17AAG IC 50 : 88.0 nm Compound (nm) Compound (nm) Resistant cell lines STA-9090 selectively inhibits the growth of a subgroup of NSCLC cells. Du et al, Unpublished data IC50 (nm) Sensitive cell lines 5

6 Ganetespib is broadly active in NSCLC with EGFR mutations Cell Line EGFR Status ERBB2 Status KRAS Status Other Erlotinib 17-AAG Ganetespib H3255 L858R Wild-type Wild-type Sensitive HCC827 Del E746_A750 Wild-type Wild-type Sensitive 18 7 PC9 Del E746_A750 Wild-type Wild-type Sensitive 7 2 NCI-H1975 L858R/T790M Wild-type Wild-type Resistant 75 <1 NCI-H820 Del747_L751, Ins S/T790M Wild-type Wild-type Resistant 34 3 DFCI-LU011 Del L747_E749, A750P Wild-type Wild-type Resistant NCI-H1650 Del E746_A750 Wild-type Wild-type Resistant 7 7 NCI-H1781 Wild-type G776insV_G/C Wild-type Resistant 22 2 NCI-H1734 Wild-type Wild-type G13C Resistant A549 Wild-type Wild-type G12S Resistant NCI-H460 Wild-type Wild-type Q61H Resistant NCI-H358 Wild-type Wild-type G12C Resistant 3 1 A427 Wild-type Wild-type G12D Resistant 4 <1 NCI-H441 Wild-type Wild-type G12V Resistant NCI-H1299 Wild-type Wild-type Wild-type NRAS(Q61K) Resistant 36 6 NCI-H1666 Wild-type Wild-type Wild-type BRAF(G466V) Medium 27 6 NCI-H1819 Wild-type Wild-type (Amp) Wild-type Sensitive NCI-H1703 Wild-type Wild-type Wild-type Resistant 3 3 NCI-H596 Wild-type Wild-type Wild-type RB Null Resistant 3,500 7 NCI-H522 Wild-type Wild-type Wild-type Resistant 7 6 HCC1833 Wild-type Wild-type Wild-type Resistant 4 <1 Calu-3 Wild-type Wild-type (Amp) Wild-type Resistant 16 9 T.Shimamura & G.Shapiro, Dana-Farber Cancer Institute; AACR-NCI-EORTC Nov

7 Rationale for Combining Hsp90 inhibitors and Taxanes Both drugs have single agent activity in NSCLC Ganetespib and docetaxel have synergistic MOAs Cell cycle Both drugs affect microtubule assembly Hsp90 inhibitors interfere with taxane resistance mechanisms (eg, AKT expression, anti-apoptotic signaling through VEGF) Effects of Hsp 90 inhibition on microenvironment sensitize tumors to docetaxel (vasculature, blood flow, metabolic state) Non-overlapping toxicity profile Docetaxel DLT is bone marrow toxicity Ganetespib DLT is diarrhea 7

8 In vitro Synergy between Ganetespib and Docetaxel in H522 NSCLC cells % Viability Ganetespib (nm) % Dead Cells % Viability Docetaxel (nm) Ganetespib (30 nm) Docetaxel (1 nm) ganetespib (30 nm) Docetaxel (1 nm) Combination H522 NSCLC cells Combo 8

9 In vivo Synergy Between Ganetespib + Docetaxel Vehicle Ganetespib (50 mg/kg) Docetaxel (4 mg/kg) Ganetespib (50 mg/kg) + Docetaxel (4 mg/kg) Vehicle Ganetespib (75 mg/kg) Docetaxel (4 mg/kg) Ganetespib (75 mg/kg) + Docetaxel (4 mg/kg) 100 Average Tumor Volume (mm3) Average Tumor Volume (mm3) NCI-H1437 NSCLC Xenografts Days After Tumor Implantation i.v. Dosing (1X/Week): NCI-HCC827 NSCLC Xenografts Days After Tumor Implantation i.v. Dosing (1X/Week): 9

10 In vivo Synergy Between Ganetespib + Paclitaxel Vehicle Paclitaxel (20 mg/kg) STA-9090 (150 mg/kg) Paclitaxel (20 mg/kg) + STA-9090 (150 mg/kg) Average Tumor Volume (mm 3 ) Days After Tumor Implantation i.v. Dosing (1X/Week):

11 Combination of Taxanes with Hsp90 Inhibitors Phase I study of 17-AAG in combination with weekly paclitaxel N=25 patients with advanced solid tumors Regimen was tolerated well No overlapping toxicity No evidence of drug-drug interactions Modest anti-cancer activity Ramalingam et al, Clin 11 Cancer Res, 2008

12 Ganetespib single agent activity in patients with NSCLC 12

13 Clinical Experience of Ganetespib + Docetaxel Combination 5 patients (4 evaluable) treated with ganetespib+docetaxel combination Patient Ganetespib single agent 8 cycles 16% TL shrinkage, PD new lesions Combo 6 cycles Shrinkage both TL and new lesions Patient Ganetespib single agent 8 cycles 3% TL shrinkage, PD new lesions Combo 3 cycles Shrinkage both TL and new lesions 13

14 Phase 1 Docetaxel + Ganetespib Combination Phase I study in patients with advanced solid organ malignancies (ongoing) Docetaxel day 1 Ganetespib- days 1 & 15 N=13 patients to date Recommended phase II dose: Docetaxel 75 mg/m 2 ; Ganetespib 150 mg/m 2 DLTs- myelosuppression and diarrhea (with 200 mg/m 2 ) 7 patients are still on study 14

15 Conclusions There is strong rationale for the combination of ganetespib and docetaxel The combination is tolerated well in patients with advanced solid organ malignancies Preliminary evidence of anti-cancer activity has been observed A randomized study will soon be initiated with the combination of docatexel and ganetespib 15

16 Ganetespib + Docetaxel Phase 2b/3 NSCLC Study Stage IIIB/IV NSCLC 2 nd line R A N D O M I Z E 1:1 Docetaxel 75 mg/m 2 q3w Stratification - PS - Adeno vs non-adeno - LDH Docetaxel 75 mg/m 2 q3w Ganetespib 150 mg/m 2 D1/15 PFS OS Stage 1 N = 240 patients Regulatory advice Stage 2 N = patients 16

17 BACKUP / OMIT 17

18 Ganetespib in NSCLC We have optimized and developed a HTS soft agar assay to measure the effect of compounds on anchorage-independent cell growth. Base agar (0.6%) is dispensed to 384- well plate Agar gelation Cell in 0.4% agar is added. Incubated overnight Add compound Incubate 7 days Formation of cell colonies Add Detection Fluorescence detection % of Control H460 H1944 H STA-9090 (nm) An automated soft agar anchorage-independent cell growth assay in 384-well HTS format. (A) Assay flow. (B) STA-9090 treatment inhibited A549 and H157 cell growth in soft agar. (C) The STA-9090 selectively inhibited cell growth. 18 Du et al, Unpublished data

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