Second-line treatment for advanced NSCLC

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1 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Second-line treatment for advanced NSCLC Silvia Novello

2 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Life was so simple back in 2008

3 Di Maio M, EJC 2010

4 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY In 2017, second line therapy is no longer as simple We must now take into consideration: 1.Tumor histology 2.Molecular phenotype (EGFR, ALK, ROS1, etc), Cappuzzo 3.Frontline chemo components (i.e. bevacizumab) 4.Maintenance therapy (continuation, switch) 5. IO in First Line 6.Others (adequacy of tumor tissue, third party reimbursement, guidelines, pathways, etc)

5 INDUCTION MAINTENANCE 2 nd LINE 3 rd LINE

6 Di Maio M, JCO 2009

7 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Clinical Lung Cancer 2014

8 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Second line therapy Outside Clinical Trials (N=464, 86% of pts progressing after first line) Gridelli C et al, J Cancer Res Clin Oncol De Marinis F et al, Clinical Lung Cancer 2014

9 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Guidelines [ESMO-AIOM]

10 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Cumulative probability Treatment Options Post-platinum Progression: Docetaxel Docetaxel was the first treatment to be approved for NSCLC patients with disease progression following first-line chemotherapy Patients receiving docetaxel 75 mg/m 2 had OS of 7.5 months, compared with 4.6 months for those receiving BSC 2 Docetaxel-treated patients had a significantly higher 1-year survival rate compared with patients receiving vinorelbine or ifosfamide (32% vs. 19%; p=.025) Docetaxel 75 mg/m 2 (n=55) BSC (n=49) Survival (months) 1. Sanofi Aventis. Taxotere (docetaxel) prescribing information. Nov Shepherd FA et al. J Clin Oncol 2000;18: Fossella FV et al. J Clin Oncol 2000;18:

11 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Survival distribution function Treatment Options Post-platinum Progression: Pemetrexed in nonsquamous NSCLC Pemetrexed was approved for patients progressing after chemotherapy after it demonstrated non-inferiority vs. docetaxel, but with a better toxicity profile 1-3 In patients with nonsquamous histology, pemetrexed treatment resulted in a median OS of 9.3 months, compared with 8.0 months for docetaxel 4 Pemetrexed is only suitable for patients with nonsquamous histology Pemetrexed Docetaxel Adjusted HR 0.78 (95% CI ) Survival (months) The increased use of pemetrexed in first-line treatment means docetaxel remains an option as subsequent therapy for patients of all histologies 1. Eli Lilly and Company. Alimta (pemetrexed) prescribing information. Sep Hanna N et al. J Clin Oncol 2004;22: Weiss GJ et al. J Clin Oncol 2006;24: Scagliotti G et al. Oncologist 2009;14:253-63

12 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Overall survival (%) Treatment Options Post-platinum Progression: Erlotinib The EGFR TKI erlotinib is approved for use in unselected patients with disease progression after first-line chemotherapy 1 However, erlotinib was inferior to docetaxel for OS and PFS in patients without an EGFR mutation; other options may be preferred in this setting 2,3 Erlotinib is not recommended for patients with a poor classification following proteomic testing in patients with WT or unknown EGFR status 3, Cox model adjusted HR 0.73 (95% CI ) Erlotinib Docetaxel Survival (months) 1. Astellas Pharma and Genentech. Tarceva (erlotinib) prescribing information. June Garassino MC et al. Lancet Oncol 2013;14: NCCN Clinical Practice Guidelines for Non-Small Cell Lung Cancer, V Gregorc V et al. Lancet Oncol 2014;15:713-21

13 PROSE Patient Flow 285 patients randomized 263 included for primary analysis 3 major protocol violations 19 never received therapy Chemotherapy (129) Erlotinib (134) VS-G 88 (68%) VS-P 41 (32%) VS-G 96 (72%) VS-P 38 (28%) The patient population was 72% male, 63% adenocarcinoma, 14% never smokers, 52% ECOG PS 0, and 41% ECOG PS 1, and was well balanced between arms. Third-line treatment at progression: CT arm: 41% overall (48% VS-G and 27% VS-P) ERL arm: 52% overall (56% VS-G and 39% VS-P) *PCR amplification/sanger sequencing of common mutations PROSE Secondary Endpoint Analysis Vanesa Gregorc, MD

14 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY

15 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY

16 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY SQUAMOUS and NON-SQUAMOUS Carcinoma: rooms for improvements

17 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Gene Methylation Mutations Translocations HYPERPLASIA DYSPLASIA CARCINOMA Air Space Limitless potential for replication INVASIVE CARCINOMA Cellular proliferation through independent growth signaling Promotion of survival signals and evasion of apoptosis Bronchial Epithelium Vascular recruitment and endothelial cell growth Tissue invasion and metastasis Adapted from Weinberg RA. Sci Am. 1996;275:62-70.

18 1:1 - Stage IV NSCLC after one platinum- based chemo +/- maintenance - Prior Bev allowed - All histologies - PS 0 or 1 R A N D O M I Z E Ramucirumab 10 mg/kg + Docetaxel 75 mg/m 2 q3wks N=628 Placebo + Docetaxel 75 mg/m 2 q3wks N=625 Treatment until disease progression or unacceptable toxicity Stratification factors: ECOG PS 0 vs 1 Gender Prior maintenance East-Asia vs. ROW Primary endpoint: Overall Survival Secondary endpoints: PFS, ORR, safety, patient-reported outcomes

19 ITT population Overall Survival (%) RAM+DOC PL+DOC Censored Median (95% CI) Censoring Rate RAM+DOC 10.5 ( ) 31.8% PL+DOC 9.1 ( ) 27.0% RAM+DOC vs PL+DOC: Stratified HR (95% CI) = ( ) Stratified log-rank P =.023 Number at risk RAM+DOC PL+DOC Survival Time (months)

20 Progression-Free Survival (%) ITT population, Investigator Assessment RAM+DOC PL+DOC Censored Median (95% CI) Censoring Rate RAM+DOC 4.5 ( ) 11.1% PL+DOC 3.0 ( ) 6.7% RAM+DOC vs PL+DOC: Stratified HR (95% CI) = 0.76 ( ) Stratified log-rank P = Number at risk RAM+DOC PL+DOC Survival Time (months)

21 Response a, n (%) Ramucirumab + Docetaxel (n=628) Placebo + Docetaxel (n=625) CR 3 (0.5) 2 (0.3) p value Ramucirumab improved ORR and DCR in nonsquamous and squamous histologies PR 141 (22.5) 83 (13.3) SD 258 (41.1) 244 (39.0) PD 128 (20.4) 206 (33.0) Unknown 98 (15.6) 90 (14.4) ORR (95% CI) 144 (22.9) ( ) 85 (13.6) ( ) <.001 DCR (95% CI) 402 (64.0) ( ) 329 (52.6) ( ) <.001

22

23 Mean ASBI Total Score Mean LCSS Total Score QoL was measured using LCSS and ASBI A similar increase in symptom burden was observed in both treatment arms n = Ramucirumab Placebo * * * * * * * * * * * * * * * * * * * * * * * * Sum 30-day vis follow-up Addition of ramucirumab had no detrimental effect on QoL * * * * * * * * * * * * * * * * * * * * * * * * Sum 30-day vis follow-up n = Cycle

24 REVEL: Patient Disposition Screened (N=1825) Randomized (ITT) Population N=1253 Excluded (n=572) Patients not receiving treatment (n=4) RAM+DOC (N=628) RAM+DOC (N=627) * wt 33% mutant 2.4% unknown 64% PL+DOC (N=625) PL+DOC (N=618) * wt 31.5% mutant 2.9% unknown 65% Patients not receiving treatment (n=4) Reasons for discontinuation (N=613) PD 341 Adverse event 94 Subject decision 90 Investigator decision 37 Death due to adverse events 30 Death from study disease 12 Other 9 On treatment at data cutoff N=11 Safety Population N=1245 Reasons for discontinuation (N=611) PD 429 Adverse event 55 Subject decision 53 Investigator decision 19 Death due to adverse events 31 Death from study disease 14 Other 10 On treatment at data cutoff N=10 *Three PL+DOC arm patients were inadvertently treated with RAM and are therefore considered part of the RAM+DOC arm for the safety analyses, but the PL+DOC arm for the ITT efficacy analysis.

25 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Forest plot PFS

26 Pembrolizumab - OS by PD-L1 expression - Keynote001 <1% 1-49% 50% 14.9% second line pts SC10.04: Second-Line Therapy and Beyond in Squamous Cell NSCLC - Silvia Novello Garon E et al, NEJM 2015

27 Pembrolizumab OS&PFS by PD-L1 expression Keynote010 HR 0.53 HR 0.76 OS most impressive in 50%, but superior with Pembrolizumab in all groups PFS benefit was superior in 50%, but not significant for either Pembrolizumab dose in 1% SC10.04: Second-Line Therapy and Beyond in Squamous Cell NSCLC - Silvia Novello Herbst R et al, The Lancet 2016

28 Keynote 010: OS by by Subgroups Pembrolizumab R Herbst et al., Lancet 2016

29 Forest plot PFS

30 Primary analysis from OAK, a randomized Phase 3 study comparing atezolizumab with docetaxel in 2L/3L NSCLC Locally advanced or metastatic NSCLC 1 2 prior lines of chemotherapy, including 1 platinum based Tumor specimen available Any PD-L1 status N=1,225 enrolled Primary endpoints (first 850 enrolled patients): OS in the ITT population OS in patients with 1% PD-L1 expression Secondary endpoints: ORR, PFS, DoR, safety Stratification factors PD-L1 expression Histology Prior chemotherapy regimens R 1:1 Atezolizumab 1200 mg IV q3w No Cross-Over Docetaxel 75 mg/m 2 q3w PD or loss of clinical benefit PD One of the largest studies that tested the role of an anti PDL-1 Mab in the setting of 2/3L NSCLC F. Barlesi, et al. ESMO Abstract LBA44_PR

31 Primary analysis from OAK, a randomized Phase 3 study comparing atezolizumab with docetaxel in 2L/3L NSCLC Overall survival (%) Characteristics Atezolizuma b n = 425 Docetaxel n = 425 Median age, y y 45% 49% Male 61% 61% Nonsquamous 74% 74% Squamous 26% 26% ECOG PS, 0/1 37%/64% 38%/62% No. of prior therapies, 1/2 History of tobacco use 75%/25% 75%/25% Never 20% 17% Current/previous Known EGFR status, % 14% / 66% 16% / 67% Mutant/WT 10% / 75% 10% / 73% Median 9.6 mo (95% CI, 8.6, 11.2) 3 Overall survival, ITT (n = 850) Atezolizumab Docetaxel HR, 0.73 a (95% CI, 0.62, 0.87) P= Minimum follow-up = 19 months Months Median 13.8 mo (95% CI, 11.8, 15.7) No. at risk Atezolizumab Docetaxel F. Barlesi, et al. ESMO Abstract LBA44_PR

32 Overall survival (%) Overall survival, PD-L1 expression OS, PD-L1 expression on 1% TC or IC TC1/2/3 or IC1/2/3; 55% of patients Median 10.3 mo (95% CI, 8.8, 12.0) HR, 0.74 a (95% CI, 0.58, 0.93) P= Minimum follow-up = 19 months OS, PD-L1 expression on 50% TC or 10% IC TC3 or IC3; 16% of patients Atezolizumab HR, 0.41 Docetaxel 100 b (95% CI, 0.27, 0.64) P< c 80 Minimum follow-up = 19 months Median 15.7 mo (95% CI, 12.6, 18.0) Median 8.9 mo (95% CI, 5.6, 11.6) Median 20.5 mo (95% CI, 17.5, NE) Months No. at risk Atezolizuma No. 1 at risk b Atezolizuma Docetaxel b Docetaxel a Stratified HR; b Unstratified HR; c P values for descriptive purpose only. TC, tumor cells; IC, tumor-infiltrating immune cells; OS, overall survival. Barlesi et al, Atezolizumab Phase III OAK Study Months F. Barlesi, et al. ESMO Abstract LBA44_PR

33 SQUAMOUS Carcinoma: rooms for improvements

34 Previous ESMO Guidelines

35

36

37

38 PFS (%) Smoking status and response to immunotherapy in NSCLC In studies of nivolumab, a history of smoking in patients with NSCLC was associated with improved clinical response and PFS PFS by smoking exposure pack-yrs smokers (mpfs 1.7 months) Variable Smoking exposure ORR, % (n/n) [95% CI] P-value >5 pack-yrs smokers (mpfs 2.2 months) HR (95% CI) = 0.41 (0.22, 0.74), P = pack-yrs >5 pack-yrs 0 (0/14) [0, 23] 30 (20/66) [20, 43] pack-yrs smokers >5 pack-yrs smokers Months Since Treatment Initiation HR = hazard ratio; mpfs = median progression-free survival; ORR = objective response rate; PFS = progression-free survival. Hellmann MD, et al. Poster presented at ESMO 2014 (asbtr. 1229PD).

39 SC10.04: Second-Line Therapy and Beyond in Squamous Cell NSCLC - Silvia Novello Campbell JD et al, Nat Genet 2016

40 Randomize 1:1 CheckMate 017 (NCT ) - Study Design Stage IIIb/IV SQ NSCLC NIVO 3 mg/kg IV Q2W, until PD or unacceptable toxicity n = 135 Primary: OS Secondary: Endpoints Investigator-assessed ORR 1 prior platinum doublet-based chemotherapy ECOG PS 0 1 N = 272 DOC 75 mg/m 2 IV Q3W, until PD or unacceptable toxicity n = 137 Investigator-assessed PFS Correlation between PD-L1 expression and efficacy (ORR, OS, PFS), Quality of life (LCSS) DBL: December 15, 2014 At time of DBL, 199 deaths (of 272 randomized pts) were reported (86% of 231 deaths required for final analysis) The boundary for declaring superiority for OS at the pre-planned interim analysis was P <0.03 DBL, data base lock; ECOG PS = Eastern Cooperative Oncology Group performance status; IV = intravenous; LCSS = lung cancer symptom scale; PD = progressive disease; PD-L1 = programmed cell death ligand 1; SQ = squamous; Q2W = every 2 weeks; Q3W = every 3 weeks Brahamer J et al, NEJM 2015

41 Checkmate 017: Updated follow-up Reckamp K et al., WCLC 2015 ORAL 02.01

42 Checkmate 017: Updated follow-up Reckamp K et al., WCLC 2015 ORAL 02.01

43 OS and PFS Hazard Ratios by PD-L1 Status PD-L1 expression Patients, n NIVO DOC Unstratified HR(95% Cl) OS 1% (0.45, 1.05) <1% (0.37, 0.92) 5% (0.31, 0.89) <5% (0.47, 1.02) 10% (0.28, 0.89) <10% (0.48, 1.01) Not quantifiable at baseline (0.19, 0.82) PFS 1% (0.44, 1.01) <1% (0.43, 1.00) 5% (0.32, 0.90) <5% (0.52, 1.08) 10% (0.33, 1.02) <10% (0.49, 0.99) Not quantifiable at baseline (0.23, 0.89) Spigel DR et al, ASCO 2015 NIVO DOC

44 Forest plot PFS

45 Is there a room for targeted therapies (WITHOUT target) in SQUAMOUS carcinoma SC10.04: Second-Line Therapy and Beyond in Squamous Cell NSCLC - Silvia Novello

46 Lux Lung 8: Study design Stratified by East Asian vs. Non-East Asian SCC of the lung (Stage IIIB/IV) 1 Progressed after 4 cycles of a first-line platinum doublet ECOG PS 0 1 Adequate organ function 1:1 Afatinib 40 mg QD Erlotinib 150 mg QD Primary Endpoint: PFS by Independent Review Key secondary Endpoint: Overall Survival Other secondary Endpoints: ORR, DCR, tumor shrinkage, PRO, safety Dose escalation to 50 mg and dose reduction to 30 or 20 mg permitted Dose reduction to 100 or 50 mg permitted Tumor assessment at baseline, Weeks 8, 12, 16; every 8 weeks thereafter. 1. American Joint Committee on Cancer staging manual 7th edition Soria JC et al, ASCO 2015

47 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Events, % LUX LUNG 8: Safety Afatinib (n=392) Erlotinib (n=395) Any AE Drug-related AEs AEs leading to dose reduction AEs leading to discontinuations CTCAE grade 3 or higher Serious AEs Drug-related fatal AEs 1.5 Afatinib 1.3 Erlotinib (N=392) (N=395) AE category, % All Grade 3 Grade 4 All Grade 3 Grade 4 Total with related AEs Diarrhea <1 Rash/acne* Stomatitis* Fatigue* Nausea Decreased appetite Paronychia* <1 0 Dry skin Pruritus 8 < Vomiting Dehydration Goss GD IASLC Geneva 2015; Soria JC et al, ASCO 2015

48 LUX LUNG 8: Efficacy OS Forest plot PFS PFS SC10.04: Second-Line Therapy and Beyond in Squamous Cell NSCLC - Silvia Novello Soria JC et al, Lancet Oncol 2015

49 For Patients and Caregivers -A 60-page booklet in English, designed as an information guide for patients with SqCLC -The most frequent key questions from a patient with SqCLC

50 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY ADENOCarcinoma ( non-squamous ): rooms for improvements

51 LUME-Lung 1 Study Design Stage IIIB/IV or recurrent NSCLC patients after 1 st line chemotherapy (all histologies) R A N D O M I Z E 1:1 Nintedanib 200mg BID p.o., D2 21, + Docetaxel 75mg/m 2 IV, D1, 21-day cycles (n=655) Placebo BID p.o., D2 21, + Docetaxel 75mg/m 2 IV, D1, 21-day cycles (n=659) PD PD N=1314 Number of docetaxel cycles not restricted Monotherapy allowed after 4 cycles of combination therapy Stratification: ECOG PS (0 vs 1) Prior bevacizumab (yes vs no) Histology (squamous vs nonsquamous) Brain metastases (yes vs no) Primary end point: PFS Next analysis step only allowed if PFS confirmed with all PFS events at time point of OS analysis RECK LBA8011, ASCO 2013

52 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY LUME1: PFS TOTAL population ADENOCARCINOMA SQUAMOUS CARCINOMA Reck M et al, Lancet Oncol 2014

53 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY LUME1: OS Adenocarcinoma <9mo ADENOCARCINOMA Total population Reck M et al, Lancet Oncol 2014

54 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY LUME1: Safety Reck M et al, Lancet Oncol 2014

55 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Forest plot PFS

56 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY CheckMate 057: Non Squamous pts Stage IIIB/IV NON-SQUAMOUS NSCLC 1 prior platinum doublet ECOG PS 0 1 Pre-treatment (archival or recent) tumor samples required for PD-L1 analysis Prior maintenance therapy allowed Prior TKI therapy allowed for known ALK translocation or EGFR mutation N = 582 Randomize 1:1 Nivolumab 3 mg/kg IV Q2W until PD or unacceptable toxicity n = 292 Docetaxel 75 mg/m 2 IV Q3W until PD or unacceptable toxicity n = 290 Patients stratified by prior maintenance therapy and line of therapy (second- vs third-line) Primary Endpoint OS Additional Endpoints ORR b PFS b Safety Efficacy by tumor PD-L1 expression Quality of life (LCSS) NIVOLUMAB NON SQ CHECK-MATE 057 (1) OS RR(%) Median (mos) 1-yr (%) PRETREATED III/IV PS0-1 NIVO 292 PTS DOC 290 PTS p= HR Borghaei h et al, NEJM 2015 Sep 27

57 UNIVERSITY OF TORINO DEPARTMENT OF ONCOLOGY Take Home Messages Chemotherapy is still present in second line NSCLC advanced patients Antiangiogenic copound found a second youth in second line Immunotherapy plays a relevant role in this setting.at least until it will move to first line Today even more than yesterday is crucial to design a treatment algorithm for these patients not to waste therapeutic approaches

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