Do You Think Like the Experts? Refining the Management of Advanced NSCLC With ALK Rearrangement. Reference Slides Introduction

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1 Do You Think Like the Experts? Refining the Management of Advanced NSCLC With ALK Rearrangement Reference Slides Introduction

2 EML4-ALK Fusion Oncogene Key Driver in 3% to 7% NSCLC Inversion or Translocation Constitutive ALK activation oncogene addiction ALK, anaplastic lymphoma kinase; EML4, echinoderm microtubule-associated protein like 4; NSCLC, non-small cell lung cancer Soda M, et al. Nature. 27;448(7153): Kwak EL, et al. N Engl J Med. 21;363(18):

3 ALK-Positive NSCLC: Clinical Characteristics Higher prevalence of EML4-ALK fusion in patients with: Adenocarcinoma histology Never/light smoking history Younger Incidence similar: Europe (3.7%), US (8% ADC), Asia (5.8% ADC) Example: Lung Cancer Mutation Consortium Analysis of Adenocarcinomas age compared to ALK-negative NSCLC N = 643 ALK-Positive ALK-Negative P Mean age 52.3 years 59.9 years <.1 Smoking history Current Former Never 3% 33% 64% 8% 61% 31%.1 Rodig SJ, et al. Clin Cancer Res. 29;15(16): Shaw AT, et al. J Clin Oncol. 29;27(26): Varella Garcia M, et al. J Thorac Oncol. 211;6(Suppl 2): Abstract O5.1. Barlesi F, et al. J Clin Oncol. 213;31(Suppl): Abstract 8. Kris MG, et al. JAMA. 214;311(19): Sun Y, et al. J Clin Oncol. 21;28(3):

4 Which Tumors Do We Test for ALK Arrangement? Squamous 3% SCLC.3% NSCLC-NOS 14% Adenocarcinoma 83% NOS, not otherwise specified; SCLC, small cell lung cancer

5 Who Should Be Testing for ALK Rearrangement? All nonsquamous tumors in patients with advanced/recurrent disease should be tested for ALK rearrangement at primary diagnosis IRRESPECTIVE of clinical characteristics Selected squamous tumors (from patients with minimal or remote smoking history and those where diagnosis has been made on a small specimen) should strongly be considered for testing Reflex testing is recommended 2nd ESMO Consensus Conference on Lung Cancer: Pathology and Molecular Biomarkers for Non-Small-Cell Lung Cancer. Kerr KM, et al. Ann Oncol. 214;25(9):

6 Lung cancer Small cell An ALK-Testing Algorithm Not small cell Squamous Probably squamous Adenocarcinoma NSCLC Are there strong clinicopathologic indicators for oncogene addiction? YES TEST! FISH, fluorescence in situ hybridization; IHC, immunohistochemistry ALK rearrangement IHC screening If positive, confirmation by FISH

7 ALK Inhibitors Drugs Company Additional Molecular Targets Clinical Trials Status Pfizer MET, ROS1 Phase I, II, III Approved by FDA (211); approved in EU (212); clinically available in Japan (212) Ceritinib Novartis IGF1R, INSR Phase I, II, III Approved by FDA (214); approved in EU (215) Alectinib Chugai, Roche RET Phase I, II, I/II, III Breakthrough therapy designation (213) Brigatinib Ariad EGFR, ROS1 Phase I/II Breakthrough therapy designation (214) ASP326 Astellas ROS1 Phase I X-376, X-396 Xcovery MET Phase I (X-396) TSR-11 Tesaro TRK-A, TRK-B, TRK-C Phase I/IIa RXDX-11 Ignyta ROS1, TRK-A, TRK-B, TRK-C Phase I CEP-28122, CEP Teva RSK2, RSK3, RSK4 Phase I (CEP- 3744) PF Pfizer ROS1 Phase I/II Isozaki H, et al. Cancers 215;7(2):

8 Versus Ceritinib MOA Oral receptor TKI that targets ALK, ROS 1, c-met, HGFR, and RON Ceritinib Oral TKI that targets ALK Indication Toxicity Efficacy First-line treatment of ALK+ NSCLC (US only)* Second-line treatment of patients with ALK+ NSCLC (Europe and the US) Vision disorder, diarrhea, nausea, vomiting, constipation, aminotransferase elevation, edema, upper respiratory infection, dysgeusia, dizziness Treatment of patients with ALK+ NSCLC who have progressed on crizotinib (Europe and US) Diarrhea, vomiting, nausea, dehydration, ALT elevation, hypophosphatemia Outcomes PROFILE 11 (n = 125) Median PFS, months Median OS, months 12-month OS rate, % PROFILE 15 (n = 259) PROFILE 17 (n = 173) ASCEND-1 ASCEND (7.3, 12.7) 8.1 (6.8, 9.7) 7.7 (6., 8.8) 15.2 (11.1, NR 11.1 (9.3, NR) 29.6 (18., NR) NR 2.3 (18.1, NR) NR (18.4, NR) NR (NR, NR) ORR, % *EU approval on first-line use is anticipated soon based on results of PROFILE 114 trial. ALT, alanine aminotransferase; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival Tan DS-W, et al. J Clin Oncol. 215;33(suppl):Abstract 858.

9 Study Design PROFILE 114 Versus Chemotherapy Key entry criteria ALK-positive by central FISH testing a Locally advanced, recurrent, or metastatic nonsquamous NSCLC No prior systemic treatment for advanced disease ECOG PS -2 Measurable disease Stable treated brain metastases allowed R A N D O M I Z E b N = mg BID PO, continuous dosing (n = 172) Pemetrexed 5 mg/m 2 + cisplatin 75 mg/m 2 or carboplatin AUC 5-6 q3w for 6 cycles (n = 171) Endpoints Primary PFS (RECIST 1.1, IRR) Secondary ORR OS Safety Patient-reported outcomes (EORTC QLQ-C3, LC13) CROSSOVER TO CRIZOTINIB PERMITTED AFTER PROGRESSION c a ALK status determined using standard ALK break-apart FISH assay; b Stratification factors: ECOG PS (/1 vs 2), Asian vs non-asian race, and brain metastases (present vs absent); c Assessed by IRR ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC QLQ-C3, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire C3; IRR, independent radiologic review; IRR, independent radiologic review Solomon BJ, et al. N Engl J Med. 214;371(23):

10 PROFILE 114: PFS PFS Probability, % (N = 172) Chemotherapy (N = 171) Events, n (%) 1 (58) 137 (8) Median, months HR (95% CI).45 (.35-.6) P <.1 No. at risk Chemotherapy Time, Months CI, confidence interval; HR, hazard ratio. Solomon BJ, et al. N Engl J Med. 214;371(23):

11 PROFILE 114: OS OS, % Chemotherapy (N = 172) Chemotherapy (N = 171) HR (95% CI).82 ( ) P <.36 2 No. at risk Chemotherapy Time, Months CI, confidence interval; HR, hazard ratio. Solomon BJ, et al. N Engl J Med. 214;371(23):

12 PROFILE 114: Response to Treatment* Type of response, n (%) (N = 172) Chemotherapy (N = 171) Complete response 3 (2) 2 (1) Partial response 125 (73) 75 (44) Stable disease 29 (17) 63 (37) Progressive disease 8 (5) 21 (12) Could not be evaluated 7 (4) 1 (6) ORR, % (95% CI) 74 (67-81) 45 (37-53) Time to response, months Median Range Duration of response Median % CI *In the intent-to-treat (ITT) population, tumor responses were assessed with the use of Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, and were confirmed by IRR. Mok T, et al. J Clin Oncol. 214;32(5s): Abstract 82.

13 improves quality of life (QoL) and cancer-related symptoms over first-line chemotherapy Solomon BJ, et al. N Engl J Med. 214;371(23):

14 PROFILE 114: Conclusions was superior to standard first-line pemetrexed plus cisplatin chemotherapy in patients with previously untreated advanced ALK-positive NSCLC Initial treatment with crizotinib significantly prolonged PFS as compared with chemotherapy consisting pemeterxed plus cisplatin or carboplatin No significant difference in OS, probably due to low rate of death from any cause and the fact that 7% of the patients in the chemotherapy group crossed over to crizotinib treatment was associated with a signifacntly higher response rate and improvements in patient-reported measures of physical functioning, key lung-cancer symptoms (cough, dyspnea, chest pain, and fatigue) and global quality of life

15 Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, Colorado; Abstract MINI31.4. Subgroup Analyses of PROFILE 114: Intracranial Efficacy of First-Line Versus Chemotherapy in ALK-Positive NSCLC

16 Baseline Characteristics of Patients With/Without Brain Metastases at Baseline a Characteristic Brain Metastases b Present (n = 39) Chemo (n = 4) Brain Metastases Absent (n = 132) Chemo (n = 131) Age, years Median (range) 48 (29-7) 51 (25-76) 53 (22-76) 56 (19-78) Sex, n (%) Male 2 (51) 9 (23) 47 (36) 54 (41) Race, n (%) Smoking, n (%) Histology, n (%) ECOG PS, c n (%) /1 2 Time since first diagnosis, mos Caucasian Asian Other Never smoked Ex-smoker Current smoker Adenocarcinoma Large cell carcinoma Adenosquamous carcinoma Other Median (range) 2 (51) 17 (44) 2 (5) 23 (59) 13 (33) 3 (8) 35 (9) 1 (3) 2 (5) 1 (3) 35 (9) 4 (1) 2.4 (-36.) 19 (48) 18 (45) 3 (8) 28 (7) 12 (3) 38 (95) 1 (3) 1 (3) 34 (85) 6 (15) 2.4 ( ) 7 (53) 6 (45) 2 (2) 83 (63) 43 (33) 6 (5) 123 (93) 2 (2) 3 (2) 4 (3) 125 (95) 6 (5) 1.2 (-114.) 66 (5) 62 (47) 3 (2) 84 (64) 42 (32) 5 (4) 121 (92) 8 (6) 2 (2) 129 (98) 2 (2) 1.2 (-93.6) a By IRR; b Previously treated per protocol, although this criterion was not fulfilled in all cases; c At screening; data for 1 patient missing for crizotinib Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, Colorado; Abstract MINI31.4.

17 Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, Colorado; Abstract MINI31.4. Antitumor Activity: PFS and ORR a Median PFS, months (95% CI) HR (95% CI) ITT Population (N = 172) 1.9 ( ).45 (.35-.6) Chemo (N = 171) 7. ( ) Brain Metastases Present b (n = 39) 9. ( ).4 ( ) Chemo (n = 4) 4. ( ) Brain Metastases Absent b (n = 132) 11.1 ( ).51 ( ) P c <.1 <.1 <.1 Chemo (n = 131) 7.2 ( ) ORR, % (95% exact CI) Difference d (95% exact CI) 74 (67-81) 29 (2-39) 45 (37-53) 77 (61-89) 49 (3-69) 28 (15-44) 74 (66-82) 24 (13-35) P e <.1 <.1 <.1 a By IRR; b At baseline; c Two-sided log-rank test (ITT population: stratified; patient subgroups with/without baseline brain metastases: unstratified); d vs chemotherapy; e Two-sided Pearson χ 2 test 5 (42-59)

18 Intracranial DCR a in Patients With Brain Metastases at Baseline (n = 39) Chemotherapy (n = 4) Intracranial DCR (95% Exact CI; %) Difference: 4% (95% CI: 21-59) P<.1 b Difference: 31% (95% CI: 11-52) P =.6 b 12 Weeks 24 Weeks DCR, disease control rate (% CR + PR + SD); a By IRR; b Two-sided Pearson χ 2 test Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.4.

19 Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, Colorado; Abstract MINI31.4. Intracranial TTP a in Patients With/Without Brain Metastases at Baseline Probability of No Progression, % No. at risk Chemotherapy Brain Metastases Present (n = 39) Chemo (n = 4) Events, n (%) 9 (23) 12 (3) Median, mo HR (95% CI).45 ( ) P b Time, Months Brain Metastases Absent a Time from randomization to first documentation of intracranial tumor progression by IRR; b Two-sided log-rank test Probability of No Progression, % No. at risk Chemotherapy Time, Months (n = 132) 2 3 Chemo (n = 131) Events, n (%) 16 (12) 14 (11) Median, mo NR NR HR (95% CI).69 ( ) P b

20 Solomon BJ, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, Colorado; Abstract MINI31.4. Conclusions In patients with baseline brain metastases, compared with chemotherapy, first-line crizotinib: Demonstrated a statistically significant improvement in intracranial DCR at 12 weeks and 24 weeks Showed a numerical improvement in intracranial TTP should be the standard first-line therapy for patients with ALK-positive NSCLC, including those with treated brain metastases at baseline

21 Subgroup Analyses of PROFILE 114: QoL in the Subpopulation of Patients of Asian Ethnicity Blackhall F, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.12.

22 Ethnicity PROFILE 114 QoL Subanalysis: Patient Characteristics Of 343 patients randomized, 46% were of Asian ethnicity (crizotinib, n = 77; chemotherapy, n = 8) (n = 77) n (%) Chemotherapy (n = 8) n (%) Japanese 14 (8.1) 18 (1.5) Chinese 3 (17.4) 26 (15.2) Korean 27 (15.7) 32 (18.7) Other Asian 6 (3.5) 4 (2.3) The majority of the Asian patients were nonsmokers (65% vs 68%), ECOG PS -1 (96% vs 97%) and had adenocarcinoma histology (91%) Completion rates at baseline and in most cycles were 95% in each group Baseline scores were similar between the groups for all domains and items in the EORTC QLQ-C3 and LC13 Symptoms with the highest mean baseline scores were fatigue, cough, dyspnea, and pain in chest and were similar in both treatment groups Blackhall F, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.12.

23 EORTC QLQ-C3 Global QoL and Functioning: Overall Change from Baseline Overall Change From Baseline ** ** Global QoL Physical Functioning Social Functioning * Emotional Functioning ** Role Functioning Chemotherapy Cognitive Functioning Improvement *P<.5; **P<.1 Blackhall F, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.12.

24 EORTC QLQ-C3 Symptoms: Overall Change From Baseline Overall Change From Baseline ** Fatigue Constipation Diarrhea Nausea and vomiting ** ** Appetite loss Chemotherapy * ** Insomnia Pain Improvement *P<.5; **P<.1 Blackhall F, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.12.

25 Conclusions In the subgroup of patients of Asian ethnicity with previously untreated advanced/metastatic ALK-positive NSCLC, treatment with crizotinib (n = 77) showed a statistically significantly greater overall improvement in patient-reported lung cancer symptoms (cough, pain in chest, dyspnea) and global QoL compared with chemotherapy (n = 8) These results are consistent with previously reported results in the overall study population Blackhall F, et al. Presented at: 16 th World Conference on Lung Cancer; September ; Denver, CO; Abstract MINI31.12.

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