14,30 18,20. II Sessione. Moderatori: Giovanni Apolone, Roberto Labianca
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1 14,30 18,20 II Sessione Moderatori: Giovanni Apolone, Roberto Labianca
2 15,10 15,30 Ca polmonare (never smokers): attualità e prospettive di ricerca Giulio Metro
3 Ca polmonare (never smokers): attualità e prospettive di ricerca Giulio Metro S.C. Oncologia Medica Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia Medicina di precisione e target in oncologia Milano 12 Maggio 2016
4 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
5 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
6 Lung cancer in never smokers 10-15% of lung cancers up to 10% of lung cancers in males up to 20% of lung cancers in females Risk factors Second-hand smoke, radon, occupation, outdoor air pollution, others (viral factors? Genetic susceptibility?) 7 th cause of cancer-related deaths worldwide
7 Smoking exposure and EGFR mutations in NSCLC Pham et al. J Clin Oncol 2006
8 Barlesi et al. Lancet 2016
9 Survival of advanced EGFR+ and ALK+ NSCLCs treated with specific TKIs EGFR-TKI treated (N = 137) 66.4.% EGFR-TKI treated (N = 137) ALK-TKI(s)-treated pts (N = 67) with crizotinib as 1 st ALK-TKI 65.8% Median OS = 40 months Lin et al. J Thorac Oncol 2016 OS (months) Chiari et al. Lung Cancer 2015
10 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
11 OS of EGFR-TKis as first-line vs chemotherapy L858R del 19 tumours Kuan et al. Br J Cancer 2015
12 Mechanisms of drug resistance to EGFR-TKIs Tanizaki et al. WLCC 2015
13 Osimertinib in T790M-positive EGFR-mutant NSCLC Yang et al. ELCC 2016
14 Activity of osimertinib Yang et al. ELCC 2016
15 PFS on osimertinib Yang et al. ELCC 2016
16 Causally-related adverse events: AURA pooled phase II Yang et al. ELCC 2016
17 Clinicaltrial.gov: NCT
18 T790M plasma and tissue positive and response to osimertinb Thress et al. Lung Cancer 2015
19 PFS in EGFRm first-line cohorts (investigator assessed) 2 nd Feb 2016: Conditional approval by EMA for T790M mutationpositive NSCLC (tissue or plasma), irrespective of previous treatment with an EGFR-TKI Ramalingam et al. ELCC 2016
20 NCT
21 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
22 T790M status and prognosis Oxnard, et al. CCR 2011 Hata, et al. Cancer 2013
23 EGFRi resistance: EGF816 (T790M inhibitor) + INC 280 (cmet inhibitor) courtesy of Novartis
24 JO25567: Erl vs Erl + Beva in EGFR mut+ : a randomized phase II study Chemotherapy-naive stage IIIB-IV or postoperative recurrence Non-squamous NSCLC Activating EGFR mutations Exon 19 deletion Exon 21 L858R Age 20 years PS 0-1 No brain metastasis Erlotinib 150mg/day + Bevacizumab 15 mg/kg q3w (N=77) 1:1R 2-yr treatment period Erlotinib 150 mg/day (N=75) PD PD Primary end-point: PFS Secondary End points: OS, ORR, QoL, symptoms improvement FACT-L scale and safety Seto et al. Lancet Oncol 2014
25 JO25567: key results Erl Erl + Bev P n ORR 64% 69% NS DCR 88% 99% DoR 9.3 months 13.3 months NS Seto et al. Lancet Oncol 2014
26 Erlotinib+bevacizumab as first-line therapy in EGFR mut+ NSCLC: the BELIEF phase II study Chemotherapy-naive stage IIIB-IV or postoperative recurrence Non-squamous NSCLC Activating EGFR mutations Exon 19 deletion Exon 21 L858R Brain metastases allowed Erlotinib 150mg/day + Bevacizumab 15 mg/kg q3w PD Primary end-point: PFS Stahel et al. ECC 2015
27 BELIEF: PFS by T790M mutation Events/N Median PFS (95%CI) 12m PFS (95%CI) All 57/ m ( ) 56.7% ( ) T790M+ 15/ m (13.1-NE) 72.4% ( ) T790M- 42/ m ( ) 49.4% ( ) Stahel et al. ECC 2015
28 BELIEF: data in relation to other studies Stahel, et al. ECC 2015
29 Randomized phase III BEVERLY trial
30 Dual PD-L1/EGFR blockade Akbay et al. Cancer Discov 2014 D Incecco et al. Br J Cancer 2015
31 Durvalumab + osimertinib Gibbons et al. ELCC 2016
32 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
33 ALK-targeted therapy: the present Fusion gene Frequency Available in clinical practice ALK 3-7% Crizotinib* (FDA, EMA) Ceritinib 1 (FDA, EMA) Alectinib 1 (FDA) ROS1 1-2% Crizotinib (FDA) *Available as 2 nd line in Italy 1 For patients refractory or intolerant to crizotinib Available on a compassionate use basis in Italy
34 Upfront crizotinib: PROFILE 1014 Solomon et al. NEJM 2014
35 Most common AEs (>10%) in PROFILE trials Landi et al.expert Opin Pharm 2014
36 Unraveling mechanisms of resistance to crizotinib Camidge, et al. Nat Reviews Clin Oncol 2014
37 New-generation ALK-TKIs: active against most secondary mutations 295: Clinical Activity and Safety of the ALK/ROS1 TK Inhibitor Lorlatinib (PF ) in Advanced NSCLC T. M. Bauer
38 PD on crizotinib: what s next? Ceritinib/Alectinib ALKpositive advanced NSCLC Crizotinib PD Crizotinib beyond PD +/- local ablative therapy Switch to chemotherapy (pemetrexed preferred) Possible Clinical trial Chemotherapy + ongoing crizotinib Investigational
39 Ceritinib development program Ceritinib is being evaluated in patients with ALK+ NSCLC in the ASCEND clinical trial program ASCEND 1 to 5 à enrollment of over 900 patients with ALK+ NSCLC Include ALKi-naïve patients Additional clinical experience outside of trials with CUP (>600pts)
40 Ascend-1: anti-tumor activity of ceritinib Efficacy Parameter ALK inhibitorpretreated N = 163 ALK inhibitornaïve N = 83 Complete response, n (%) 3 (2) 1 (1) Partial response, n (%) 89 (55) 59 (71) Stable disease, n (%) 29 (18) 14 (17) Progressive disease, n (%) 16 (10) 0 Unknown, n (%) 26 (16) 9 (11) 12-month duration of response 26% (16-36) 64% (49-76) 12-month PFS 27% (20-35) 62% (50-72) 12-month OS 67% (59-74) 83% (72-90) Kim et al., Lancet Oncol 2016
41 Ascend-1: PFS on ceritinib 18.4 months 6.9 months Kim et al., Lancet Oncol 2016
42 Ascend-2: AEs regardless of relationship to study drug (> 20% for all grades) (N = 140) Preferred Term All Grades, n (%) Grade 3/4, n (%) Nausea 114 (81.4) 9 (6.4) Diarrhea 112 (80.0) 9 (6.4) Vomiting 88 (62.9) 6 (4.3) Alanine aminotransferase increased 61 (43.6) 24 (17.1) Decreased appetite 57 (40.7) 5 (3.6) Fatigue 51 (36.4) 9 (6.4) Weight decreased 48 (34.3) 6 (4.3) Aspartate aminotransferase increased 45 (32.1) 7 (5.0) Abdominal pain 44 (31.4) 2 (1.4) Constipation 40 (28.6) 3 (2.1) Cough 30 (21.4) 0 Pyrexia 29 (20.7) 4 (2.9) Dyspnea 29 (20.7) 8 (5.7) Adverse events leading to permanent discontinuation in 7.9% of patients (N = 11) Mok et al., ASCO 2015
43 Alectinib: in crizotinib-pretreated patients North American NP28761 phase 1/2 study (N = 67) ORR = 52% Global NP28673 study (N = 122) ORR = 50% Shaw, et al. Lancet Oncol 2016 Ou, et al. J Clin Oncol 2016
44 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
45 ALK-positive NSCLC is significantly associated with PD-L1 expression Cappuzzo et al. Br J Cancer 2015 Ota et al. Clin Cancer Res 2015
46 ALK-TKI + immunotherapy: Javelin Lung 102 Patient enrollment is planned to begin in the third quarter of 2016 Target population: 1 st line ALK-positive NSCLC 1:1:1 N = 551 pts Primary endpoint: PFS (BIRC assessed) R A N D O M I Z E Crizotinib n = 187 pts Lorlatinib n = 187 pts Lorlatinib + Avelumab Stratification factor: ECOG PS Smoking satus n = 187 pts No cross-over is permitted
47 Outline Background EGFR-mutant NSCLC ü Present ü Research ALK-positive NSCLC ü Present ü Research Minor drivers
48 Molecular subclassification makes molecularlydefined lung adenocarcinoma a rare disease Boyd et al. Lancet Oncol 2016
49 NGS in never/light smokers with lung ADC with negative non-ngs tests* coding exons of 287 cancerrelated genes introns of 19 frequently rearranged genes *EGFR, HER2, KRAS,NRAS, BRAF, MAP2K1, PI3KCA, AKT1, ALK, ROS1, RET Drilon et al. Clin Cancer Res 2015
50 Why struggling in order to find the target? Kris et al. JAMA 2014 Barlesi et al. Lancet 2016
51 Low frequency drivers: challenges A separate trial for each drug or genotype population? How relevant is prior treatment with chemo? Chemonaive vs pretreated Do we always need a chemo (or placebo) comparator? Which threshold of activity (RR, PFS) make this unnecessary Historical comparisons may not be approppiate Prospective phase II-III trials Courtesy of Scagliotti AIOM 2013
52 Hyman et al. NEJM 2015
53 Phase 2 BRAF basket trial: results Hyman et al. NEJM 2015
54 CUSTOM basket trial: good idea, wrong setting Unfeasible to complete accrual Lopez-Chavez et al. J Clin Oncol 2015
55 Basket trials The tumor must depend on the target pathway The targeted therapy must reliably inhibitthe target Large number of institutions and/or adaptive design are key to the success of such studies
56 Stratification for EGFR, ALK and histology EGFR mutated (appr %) ALK+/ROS1+ (appr. 5%) EGFR/ALK WT non-squamous squamous 1 st or 2 nd generation EGFR-TKI Osimertinib (T790M+) Platinum + pemetrexed +/- bevacizumab (T790M-) Clinical trials! Crizotinib (only for ALK+ in Europe) Ceritinib / crizotinib beyond PD Platinum + pemetrexed Platinum + pemetrexed +/- bevacizumab Platinum-based doublet
57 Thanks for your attention
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