2 nd line Therapy and Beyond NSCLC. Alan Sandler, M.D. Oregon Health & Science University
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1 2 nd line Therapy and Beyond NSCLC Alan Sandler, M.D. Oregon Health & Science University
2 Treatment options for advanced or metastatic (stage IIIb/IV) NSCLC Suitable for chemotherapy Diagnosis Unsuitable/unwilling for chemotherapy Platinum-containing chemotherapy or single-agent chemotherapy for elderly or poor PS patients First line Best supportive care or clinical trial Disease progression Tarceva monotherapy Disease progression Chemotherapy (docetaxel or pemetrexed) Disease progression Second line Chemotherapy? Tarceva monotherapy Third line NSCLC = non-small-cell lung cancer; PS = performance status
3 Second-line Treatment for Advanced NSCLC Study Treatment Overall Response Rate Median Survival Time P-value Hanna et al. 1 Pemetrexed Docetaxel 9.1% 8.8% 8.3 months 7.9 months NS Shepherd et al. 2 Erlotinib Placebo 8.9% <1.0% 6.7 months 4.7 months <0.001 Shepherd et al. 3 Docetaxel BSC 7.0% 7.0 months 4.6 months < Hanna N, et al. J Clin Oncol. 2004;22: ; 2. Shepherd FA, et al. N Engl J Med. 2005;353: ; 3. Shepherd FA, et al. J Clin Oncol. 2000;18:
4 Prospective Trial of Second-line Treatment: Shepherd et al. N=204 Stage IIIB/IV NSCLC Failed/intolerant to 1 prior chemotherapy regimen PS 0-2 R A N D O M I Z E Docetaxel 100 mg/m 2 (n=49) Docetaxel 75 mg/m 2 (n=55) Best supportive care (n=100) Primary endpoint Overall survival Secondary endpoints Objective tumor response Duration of response Changes in quality of life Shepherd FA, et al. J Clin Oncol. 2000;18:
5 Chemotherapy versus BSC in Second-line Therapy of NSCLC Median overall survival 1-year survival Combined Docetaxel Arms BSC P- value 7.0 mos 4.6 mos % 19% Shepherd FA, et al. J Clin Oncol. 2000;18:
6 Hanna N, et al. J Clin Oncol. 2004;22: Phase III Pemetrexed versus Docetaxel for Second-line NSCLC N=571 Stage IIIB/IV NSCLC Failed/intolerant to 1 prior chemotherapy regimen PS 0-2 R A N D O M I Z E Pemetrexed 500 mg/m 2 + Vitamin B 12 + Folic acid + Dexamethasone (n=283) Docetaxel 75 mg/m 2 + Dexamethasone (n=288) Primary endpoint Overall survival Secondary endpoints Toxicity Objective response rate Progression-free survival Time to progression Quality of life
7 Pemetrexed vs Docetaxel: Survival Outcome Pemetrexed Group Docetaxel Group P-value MST 8.3 months 7.9 months NS 1-year survival 29.7% 29.7% NS Hanna N, et al. J Clin Oncol. 2004;22:
8 BR.21 Study Design Stratified by: Centre PS, 0/1 vs 2/3 Response, CR/PR vs Stable vs Prog n Prior regimens, 1 vs 2 Prior platinum, Yes vs no R A N D O M I S E Erlotinib* 150 mg daily Placebo 150 mg daily *2:1 Randomization Shepherd, et al. Proc ASCO 2004 (abstract 7022)
9 Percentage BR.21 Progression Free Survival Erlotinib, Placebo *HR 0.61, p=<0.001 PFS 2.2 mo. vs. 1.8 mo Months *Adjusted for stratification factors 8
10 Percentage BR.21 Overall Survival Erlotinib, Placebo *HR 0.72, p=0.001 MST 6.7 mo. vs. 4.7 mo. 31% % Months *Adjusted for stratification factors
11 Second line: Single Agent vs Combination Overall survival PFS Di Maio M et al. JCO 2009;27: by American Society of Clinical Oncology
12 Future Directions EML4-ALK cmet Inhibitors
13 Lung Cancer Mutation Consortium Molecular Abnormalities in lung adenocarcinoma Kris, Kris, et all ASCO 2011 n= 1000 Mutation found in 54% (280/516) of tumors completely tested (CI 50-59%)
14 Maximum change in tumor size (%) Tumor Responses to Crizotinib for Patients with ALK-positive NSCLC Progressive disease Stable disease Confirmed partial response Confirmed complete response % *Partial response patients with 100% change have non-target disease present *
15 c-met Pathway and c-met Signaling Inhibition Strategies Eder J P et al. Clin Cancer Res 2009;15: by American Association for Cancer Research
16 cmet Inhibitors Agent Company MOA Phase METMab Genentech Anti-c-MET Ab II AMG102 Amgen Anti-HGF Ab II (RCC, GBM, Prostate, others) Tivantinib ARQ 197 Arqule/Daiichi Selective c-met TKI III Cabozantinib (XL184) Exelixis/BMS Non-selective c-met, VEGFR2 and RET TKI II
17 5 Phase II: Erlotinib +/- MetMAb in Key eligibility: Stage IIIB/IV NSCLC 2 nd /3 rd -line NSCLC Tissue required PS 0 2 n=137* 2 nd/ 3 rd -line NSCLC R A N D O M I Z A T I O N Stratification factors: Tobacco history Performance status Histology Arm A Arm B MetMAb (15 mg/kg IV Q3W) + erlotinib (150 mg daily) Placebo (IV Q3W) + erlotinib (150 mg daily) n=69 n=68 Co-primary objectives: Other key objectives: PD PFS in Met Diagnostic positive patients (est. 50%) PFS in overall ITT population OS in Met Diagnostic Positive pts OS in overall ITT patients Overall response rate Safety/tolerability Add MetMAb Must be eligible to be treated with MetMAb n=27 Schiller, et al ASCO 2010
18 Probability of progression free Probability of survival MetMAb plus erlotinib in ITT population PFS: HR=1.09 Median (mo) HR (95% CI) Log-rank p-value No. of events Placebo + erlotinib MetMAb + erlotinib ( ) OS: HR=0.8 Median (mo) HR (95% CI) Log-rank p-value No. of events Placebo + erlotinib MetMAb + erlotinib ( ) Time to progression (months) Overall survival (months) 8
19 Probability of progression free Probability of survival MetMAb plus erlotinib in Met Dx+ patients PFS: HR=0.53 OS: HR= Median (mo) HR (95% CI) Log-rank p-value No. of events Placebo + erlotinib MetMAb + erlotinib ( ) Median (mo) HR (95% CI) Log-rank p-value No. of events Placebo + erlotinib MetMAb + erlotinib ( ) Time to progression (months) Overall survival (months) 9
20 ARQ 197 (Tivantinib): a Novel and Selective Tyrosine Kinase Inhibitor Non-ATP competitive inhibitor of c-met Novel mechanism of binding stabilizes inactive conformation of c-met 1 Compound demonstrates broad-spectrum, anti-tumor activity in a number of tumor xenograft models (including NSCLC) In vivo anti-tumor activity of ARQ EGFR inhibitor greater than either drug alone 2 Demonstration of safety and linear PK in phase I combination with EGFR inhibitor erlotinib 3,4 1. Munshi N et al. Mol Cancer Ther 2010;Epub ahead of print 2. Unpublished; courtesy of ArQule, Inc. and Kyowa Hakko Kirin Co., Ltd 3. Laux I et al. ASCO Goldman J et al. IASLC 2009
21 Proportion of Patients Progression-Free Results of the Phase 2 Trial Progression-Free Survival Patients N Erlotinib HR = (95% placebo CI, ); 83 P <.05 a 2.2 Erlotinib + tivantinib Erlotinib + placebo Median PFS, months Erlotinib + tivantinib Time From Randomization, months ITT population - Adjusted for sex, prior chemotherapy, best prior response, time from diagnosis, and EGFR mutation status.
22 Proportion of Patients Progression- Ffree Results of the Phase 2 Trial The PFS benefits in the subset of patients with non-squamous tumor histology was consistent with the ITT population (Figure 3) Patients N HR = 0.61 (95% CI, ); P <.05 a Median PFS, months E + T E + P Erlotinib + tivantinib Erlotinib + placebo T ime From Randomization, months Investigator assessment - Adjusted for sex, prior chemotherapy, best prior response, time from diagnosis, and EGFR mutation status.
23 Results of the Phase 2 Trial A PFS benefit associated with tivantinib plus erlotinib was observed in patients with tumors harboring amplified c-met, wild-type EGFR, or mutant KRAS n/n Median PFS (95% CI), months Tivantinib + Placebo + Erlotinib Erlotinib Squamous cell 26/ ( ) 2.0 ( ) Non-squamous cell 58/ ( ) 2.3 ( ) c-met FISH > 4 19/ ( ) 3.6 ( ) c-met FISH > 5 8/ (3.8 - NE) 3.6 ( ) EGFR mutant 6/ ( ) 4.9 ( ) EGFR wt 51/ ( ) 1.9 ( ) KRAS mutant 10/5 2.3 (1.8 - NE) 1.0 ( ) KRAS wt 49/ ( ) 2.3 ( ) 0.18 Unadjusted HR Favors ARQ 197/Erlotinib Favors Placebo/Erlotinib Cox proportional hazard ratio analysis of median progression-free survival by patient subgroup.
24 MARQUEE Phase III Study Design The MARQUEE study is a multicenter, phase 3, randomized, doubleblind, placebo-controlled clinical trial (Figure 5) 8 Phase 3 in NSCLC Inoperable, locally advanced or metastatic disease Non-squamous histology 1-2 regimens of prior chemo (no prior EGFR TKI) Prior platinum-based doublet therapy required R A N D O M I Z E Arm A: Arm B: Tivantinib (ARQ 197) Erlotinib mg PO QD 360 mg PO BID Placebo PO BID + Erlotinib 150 mg PO QD Endpoints 1 : OS (ITT population) 2 /Exploratory: PFS (ITT population) PK and PD analysis OS and PFS in EGFR wt patients Safety and toxicity QOL/FACT-L Biologic subgroup analysis Stratification by EGFR and KRAS mutational status
25
26 Outline EGFR inhibition Rationale EGFR-TKIs and Antibodies Chemotherapy-naïve patients Previously treated patients Angiogenesis Combining targeted agents
27 Second-line Treatment Options Increasing need for second-line treatment due to improved 1-year survival rates for first-line, platinum-based chemotherapy Relapsed NSCLC more likely to be resistant to agents used in first-line therapy Many new active drugs available (response rates are generally less than 10%) Pemetrexed (folate antimetabolite) Docetaxel (taxane) Erlotinib (tyrosine kinase inhibitor) Hanna N, et al. J Clin Oncol. 2004;22: ; Shepherd FA, et al. N Engl J Med. 2005;353:
28 Stinchcombe, et al The Oncologist 2008
29 Stinchcombe, et al The Oncologist 2008
30 EGFR-Inhibition Second/Third-line Therapy Phase III Trials
31 BR.21 Exploratory Analysis: Phase III Trial of Erlotinib for Advanced NSCLC Survival Across Subgroups Subset n All patients 731 PS PS Male 475 Female 256 <65 y y 279 Adenocarcinoma 365 Squamous cell carcinoma 222 Other histology 144 Prior weight loss <5% 486 Prior weight loss 5%-10% 132 Prior weight loss >10% 81 Never smoked 146 Current/ex-smoker prior regimen prior regimens 367 Tarceva (erlotinib) PI. Decreased risk of death Increased risk of death
32 BR.21 Exploratory Analysis: Phase III Trial of Erlotinib for Advanced NSCLC Survival Across Subgroups Subset n All patients 731 Prior platinum 678 No prior platinum 53 Prior taxane 267 No prior taxane 464 Best prior response: CR/PR 292 Best prior response: SD 287 Best prior response: PD 152 Dx to randomization: <6 mo 97 Dx to randomization: 6-12 mo 242 Dx to randomization: >12 mo 392 EGFR-positive* 127 EGFR-negative 111 EGFR-unknown 493 *EGFR status defined by immunohistochemistry. SD = stable disease. Tarceva (erlotinib) PI. Decreased risk of death Increased risk of death
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