Carcinoma escamoso: optimizacio n de tratamiento. Noemi Reguart Hospital Clínic Barcelona

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1 Carcinoma escamoso: optimizacio n de tratamiento Noemi Reguart Hospital Clínic Barcelona

2 National Cancer Database (US) 80% 70% 60% 50% 40% 30% Incidence of SCC 27% 20% 10% 0% SCC 35% 28% 26% 27% Non SCC 65% 72% 75% 72% An oncology outcomes database administered by the American College of Surgeons and the American Cancer Society M. Behera WCLC 2015

3 NSCLC Classification

4 X40 Courtesy of J.C. Soria

5 178 resected lung SqCC Squamous NSCLC has a high somatic mutation burden and complex tumor genetic alterations The Cancer Genome Atlas (TCGA) initiative Imielinski, TCGA, Nature 2012

6 TCGA : Focal copy number alterations in SCC Amplifications Deletions MYCL MCL1 NFE2L2 REL SOX2 PDGFRA LRP1B ERBB4 FOXP1 EGFR FGFR1 CSMD1 CDKN2A MDM2 ERBB2 CCND1 RB1 PTEN CRKL The Cancer Genome Atlas (TCGA) initiative Imielinski, TCGA, Nature 2012

7 PI3K and FGFR1 the 2 main pathways? Comprehensive genomic profiling of 79 stage IV SQCLCs 2 major SqCLC subtypes: FGFR1 amplified and PI3K aberrant. PI3K-aberrant tumors had worse survival and more brain mets Cancer Discovery, April 30, 2015 MINI13.05: Marc Ladanyi Discussant Paik P et al, Cancer Discovery 2015

8 Most common Driver mutations in lung cancer Adenocarcinoma Squamous cell Gene Lung ADC Lung Squamous Cell EGFR 14%, most at known sites Amplification (7%), rare non-canonical mutation (L861Q) KRAS 31% mutation 1%, HRAS more common BRAF 10%, 2% (V600/601) 4%, (no V600/601) PIK3CA 7% mutation 16% mutation ERBB2 5% mutation 3% non-canonical, rare amplification (<5%) FGFRs 2% mutation 10% amplification, 12% mutation, fusions DDRs 3% mutation 4% mutation Mountain, Chest 1997 Lung Cancer Consortium, ASCO 2011; Perez-Moreno et al. Clin Cancer Res 2012; Y. Shi, WCLC 2015

9 Overall survival % Overall survival Overall survival First line Chemotherapy Pacli + carbo (PCb) Cis + vin (CV) Pacli + cis (PC) Gem + cis (GC) Doc + cis (DC) Pacli + carbo (PCb) Pacli + carbo (PCb) Gem + cis (GC) Cis + vin (CV) Months Months Months 30 Study arm OS (mo) 1 year (%) PCb CV Study arm OS (mo) 1 year (%) PC GC DC PCb Study arm OS (mo) 1 year (%) PCb GC CV Kelly et al. J Clin Oncol 2001 Schiller et al. N Engl J Med 2002 Scagliotti, et al. J Clin Oncol 2002 N. Thatcher ELCC 2015

10 New chemo standards?... Probably not Nab-Paclitaxel Nab-Paclitax. Carboplatin Paclitaxel CBDCA Docetaxel Nedaplatin WJOG5208L Docetaxel CDDP N ORR (%) 41 24* PFS (mo) * OS (mo) * G3-5 AE (%) * Statistically significant M. Socinski, Ann Oncol 2013 Takehito Shukuya, Lancet Oncology 2015

11 . Necitumumab is a second-generation human IgG1 anti-egfr monoclonal antibody First-line Stage IV Squamous-LC ECOG PS 0-2 R N=1093 Neci + Gem-Cis q3w (N=545) Necitumumab 800 mg D1, D8 Gemcitabine 1250 mg/m², D1, D8 Cisplatin 75 mg/m², D1 Maximum of 6 cycles Gem-Cis q3w (N=548) Gemcitabine 1250 mg/m², D1, D8 Cisplatin 75 mg/m², D1 CR PR SD PD Neci q3w 800 mg D1, D8 PD PD Randomization stratified by: ECOG PS (0-1 vs. 2) and geographic region (North America, Europe, and Australia; vs. South America, South Africa, and India; vs. Eastern Asia) Primary objective: OS Patient selection not based on EGFR protein expression Mandatory tissue collection from archived tumor Thatcher N. et al. Lancet Oncol 2015

12 Overall Survival (%) SQUIRE Primary Outcome: Overall Survival (ITT) 16% reduction risk of death, 1.6 month absolute improvement in OS Similar RR 31% vs 29% (p ns) GC+N N=545 Stratified HR (95% CI) 0.84 (0.74, 0.96) GC N=548 1yr OS Stratified p-value (log-rank) 0.01 Median, months (95% CI) 11.5 (10.4, 12.6) 9.9 (8.9, 11.1) 42.8% 47.7% 2yr OS Patients / events: Neci + Gem-Cis: 545 / 418 Gem-Cis: 548 / % 19.9% Time Since Randomization (Months) Thatcher N. et al. Lancet Oncol 2015

13 SQUIRE Exploratory Analysis: EGFR H-Score EMA approved only in EGFR expressing tumours, IHC (DAKO PharmDx): BUT only 5% tumors did not express EGFR (small sample size) OS H-Score >0 vs < 0: OS 11.7 vs 10 (HR 0.81) Thatcher et al. Lancet Oncol 2015; Paz-Ares Annals of Oncol 2016

14 Median OS (months) Second Line.very poor outcomes 9 < 9 months etaxel 0 Ifosfamide or vinorelbine Docetaxel Ifosfamide BSC or Pemetrexed Docetaxel Docetaxel BSC Pemetrexed Erlotinib Docetaxel Placebo Erlotinib Placebo vinorelbine TAX320 TAX317 TAX320 TAX317 JMEI BR.21 JMEI BR Fossella 2000; 2. Shepherd 2000; 3. Hanna 2004; 4. Shepherd 2005

15 * Ramucirumab, a fully human monoclonal antibody that specifically binds VEGFR2 Squamous: 157 (25%) Primary endpoint: OS Secondary: PFS, ORR, safety Analysis by histology NOT preplanned Squamous: 171 (27%) Garon EB et al. Lancet 2014;384:665-73

16 REVEL Primary Outcome: Overall Survival (ITT) 14% reduction risk of death, 1 month improvement in OS Garon EB et al. Lancet 2014

17 REVEL: Overall Survival by Histology * Subgroup analyses by histology in this study were not pre-planned Garon EB et al. Lancet 2014

18 REVEL: AEs of interests by histology Treatment Emergent Adverse Events Bleeding/ Haemorrhage* Epistaxis Gastrointestinal haemorrhage* Pulmonary haemorrhage* Haemoptysis Hypertension* Infusion-related reaction* Proteinuria Grade Nonsquamous Ramucirumab (N=465) Placebo (N=441) Ramucirumab (N=157) Squamous Placebo (N=170) Any 145 (31.2) 60 (13.6) 36 (22.9) 33 (19.4) 3/4/5 11 (2.4) 8 (1.8) 4 (2.5) 5 (2.9) Any 97 (20.9) 30 (6.8) 19 (12.1) 9 (5.3) 3/4/5 2 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) Any 14 (3.0) 7 (1.6) 3 (1.9) 3 (1.8) 3/4/5 3 (0.6) 1 (0.2) 1 (0.6) 1 (0.6) Any 34 (7.3) 25 (5.7) 15 (9.6) 21 (12.4) 3/4/5 5 (1.1) 4 (0.9) 3 (1.9) 4 (2.4) Any 25 (5.4) 16 (3.6) 11 (7.0) 16 (9.4) 3/4/5 3 (0.6) 2 (0.5) 1 (0.6) 2 (1.2) Any 54 (11.6) 23 (5.2) 14 (8.9) 6 (3.5) 3/4/5 27 (5.8) 13 (2.9) 8 (5.1) 0 (0.0) Any 18 (3.9) 20 (4.5) 5 (3.2) 8 (4.7) 3/4/5 4 (0.9) 3 (0.7) 1 (0.6) 1 (0.6) Any 15 (3.2) 5 (1.1) 6 (3.8) 0 (0.0) 3/4/5 1 (0.2) 0 (0.0) 0 (0.0) 0 (0.0) P value <0.05 between treatment groups, comparison based on Fisher s exact tests *Consolidated AE category comprising synonymous MedDRA preferred terms. Garon EB et al. Lancet 2014

19 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 N=795 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 Stratified by east Asian vs non-east Asian *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 Soria, Lancet Oncol 2015

20 Estimated PFS probability Estimated OS probability LUX-Lung 8: Primary endpoint PFS 19% reduction risk of death, <1 month improvement in OS Similar RR 6% vs 3% (p ns) PFS OS Median, months (95% CI) Afatinib n= ( ) HR (95% CI) 0.81 ( ) p value Erlotinib n= ( ) Median, months (95% CI) Afatinib n= ( ) HR (95% CI) 0.81 ( ) p value Erlotinib n= ( ) % % 22.0% % Time of progression-free survival (months) Time of overall survival (months) Soria, Lancet Oncol 2015

21 LUX-Lung 8: Predictive analysis by OS Subgroup Aberration present (%) HR (95% CI) SVs CNAs Predefined families: y aberration LL8 LL8 subset* (n=238) EGFR TP53 LRP1B MLL2 CDKN2A FAT3 EGFR SOX2 KLHL6 PIK3CA MAP3K13 BCL6 FGF12 ERBB FGF No (94.1) Yes (5.9) No (12.2) Yes (87.8) No (60.5) Yes (39.5) No (67.2) Yes (32.8) No (71.4) Yes (28.6) No (72.3) Yes (27.7) No (93.7) Yes (6.3) No (56.3) Yes (43.7) No (59.7) Yes (40.3) No (63.0) Yes (37.0) No (67.2) Yes (32.8) No (68.9) Yes (31.1) No (71.4) Yes (28.6) No (71.0) Yes (29.0) No (41.2) Yes (58.8) 0.82 ( ) 0.73 ( ) 0.72 ( ) 1.04 ( ) 0.54 ( ) 0.74 ( ) 0.74 ( ) 0.73 ( ) 0.68 ( ) 0.83 ( ) 0.75 ( ) 0.68 ( ) 0.69 ( ) 0.75 ( ) 0.76 ( ) 0.42 ( ) 0.78 ( ) 0.70 ( ) 0.76 ( ) 0.72 ( ) 0.72 ( ) 0.78 ( ) 0.80 ( ) 0.66 ( ) 0.74 ( ) 0.79 ( ) 0.76 ( ) 0.77 ( ) 0.74 ( ) 0.70 ( ) 0.69 ( ) 0.76 ( ) Favors afatinib Favors erlotinib NONE Genetic Abnormality is predictive of benefit to afatinib treatment compared with erlotinib DO NOT not appear to be associated with longer PFS/OS J.C. Soria WCLC 2015

22 Squamous, male, heavy smoker I can t believe it! Jan 2016 June 2016 June 2017 Case report by N.Reguart, N. Vilariño

23 Squamous cell lung cancer has a very high rate of somatic mutations Squamous LC Lung adenoc 8.9 and SCC 8.1 mut/mb estimated from exome sequencing Lawrence et al. Nature 2014

24 TMB is higher in patients with smoking history Smoking history Govindan et al. Cell 2012

25 TME immuno type I common in lung tumors KRAS NSCLC MELANOMA TILs+ PD-L1+ Type I TILs- PD-L1- Type II Type IV PD-L1- TILs+ Type III PD-L1+ TILs- EGFR mutant NSCLC ALK rearranged NSCLC Ock et al. Clin Cancer Res 2016

26 PDL-1 TPS and histology PD-L1 TPS 1%_67% PD-L1 TPS 50%_ 28% * Data from KEYNOTE-001, -010, and -024 Aggarwal C, ASCO 2017

27 Randomize 1:1 CheckMate Study Design Stage IIIb/IV SQ NSCLC 1 prior platinum doublet-based chemotherapy ECOG PS 0 1 Nivolumab 3 mg/kg IV Q2W until PD or unacceptable toxicity n = 135 Primary Endpoint: OS Additional Endpoints: Investigator-assessed ORR Pre-treatment (archival or fresh) tumor samples required for PD-L1 analysis N = 272 Docetaxel 75 mg/m 2 IV Q3W until PD or unacceptable toxicity n = 137 Investigator-assessed PFS Correlation between PD-L1 expression and efficacy Safety Quality of life (LCSS) Patients stratified by region and prior paclitaxel use 100% SqCC One pre-planned interim analysis for OS At time of DBL (December 15, 2014), 199 deaths were reported (86% of deaths required for final analysis) The boundary for declaring superiority for OS at the pre-planned interim analysis was P <0.03 LCSS = Lung cancer symptom scale J. Brahmer, et al. N Engl J Med. 2015

28 OS (%) OS (%) CheckMate 017 in SCC: Primary endpoint OS Overall Survival 1 Updated OS 2 years follow-up mos mo, (95% CI) 18-mo OS rate = 13% CheckMate 017: Squamous Median OS Nivo = 9.2 months Nivolumab Docetaxel Time (months) Nivolumab (n = 135) 9.2 ( ) Docetaxel (n = 137) 6.0 ( ) # deaths HR = 0.59 (95% CI: ); P < mo OS rate = 28% yr OS=8% Time (months) 2-yr OS =23% Nivolumab Docetaxel 33 Based on August 2015 DBL. 1. J. Brahmer, et al. N Engl J Med. 2015; 2. Borghaei H et al. Poster presentation at ASCO 2016 Symbols refer to censored observations.

29 OS (%) CA Year Update: Phase 1 Nivolumab in Advanced NSCLC 100 Squamous (n = 54) 100 Non-squamous (n = 74) y OS, 41% 1 y OS, 42% y OS, 24% 3 y OS, 20% 5 y OS, 16% y OS, 24% 3 y OS, 17% 5 y OS, 15% No. at Risk Years Years Julie Brahmer, AACR 2017

30 CheckMate 017: Nivolumab benefit by PD-L1 Non-squamous NSCLC (CheckMate 057) 3 PREDICTIVE Squamous NSCLC (CheckMate 017) 1,2 NOT PREDICTIVE PD-L1 expression OS PFS 1% <1% 5% <5% 10% <10% NQ a 1% <1% 5% <5% 10% <10% NQ a Unstratified HR Interaction P-value < Unstratified HR Interaction P-value Nivolumab Docetaxel Nivolumab Docetaxel PD-L1-positive expression PD-L1-negative expression NQ 1. Brahmer J, et al. New Engl J Med. 2015;373: Spigel DR, et al. Presented at ASCO 2015, Abstract Paz-Ares L, et al. Presented at ASCO 2015, Abstract LBA109.

31 KEYNOTE 010- Study Design N = 1034 Coprimary Endpoints: OS and PFS 22% SqCC * No staification by histology Herbst R, Lancet 16

32 KEYNOTE-010: OS in ITT by PDL-1 expression OS, PD-L1 TPS 1% (total population) Treatment Arm Median (95% CI), mo Rate at 1 y HR a (95% CI) P Pembro 2 mg/kg 10.4 ( ) 43.2% 0.71 ( ) Pembro 10 mg/kg 12.7 ( ) 52.3% 0.61 ( ) < Docetaxel 8.5 ( ) 34.6% OS, PD-L1 TPS 50% stratum Treatment Arm Median (95% CI), mo HR a (95% CI) P Pembro 2 mg/kg 14.9 (10.4-NR) 0.54 ( ) Pembro 10 mg/kg 17.3 (11.8-NR) 0.50 ( ) < Docetaxel 8.2 ( ) O v e r a l l S u r v i v a l, % Time, months Pembro 2 vs 10 mg/kg: HR 1.17, 95% CI O v e r a l l S u r v i v a l, % Time, months Pembro 2 vs 10 mg/kg: HR 1.12, 95% CI Herbst R, Lancet 16

33 KEYNOTE-010: 3 years OS 29.5% 22.1% 12.3% Herbst RS, ASCO 2017

34 KEYNOTE-010: OS by Subgroups Subgroups Overall Sex Male New Histology Squamous Adenoc No. of Events/ No. of Patients 521/ / /399 Female Age <65 years 317/ years 204/429 ECOG performance status 0 149/ /678 PD-L1 tumor proportion score 50% 204/442 1% 49% 317/591 Tumor sample Archival EGFR status Mutant Wild type 266/ / / /708 46/86 447/875 Hazard Ratio (95% CI) ( ) 0.65 ( ) 0.69 ( ) 0.63 ( ) 0.76 ( ) 0.73 ( ) 0.63 ( ) 0.53 ( ) 0.76 ( ) 0.70 ( ) 0.64 ( ) 0.74 ( ) 0.63 ( ) 0.88 ( ) 0.66 ( ) Favors Pembrolizumab Favors Docetaxel Analysis cut-off date: September 30, Roy S. Herbst, ESMO ASIA 2015; Lancet 2015

35 KEYNOTE-010: Adjusted HR for OS (PD-L1 TPS 1%) Exploratory, post hoc, multivariate analyses Herbst RS, ASCO 2017

36 KEYNOTE-010: Subgroup analysis by PDL-1 Analysis of all 550 patients of antitumor activity of Pembrolizumab in advanced NSCLC enrolled in KEYNOTE-001 Hellmann WCLC 2015

37 OAK- Study Design Locally advanced or metastatic previously treated NSCLC Locally advanced/metastatic NSCLC Atezolizumab 1,200mg IV q3w Loss of clinical benefit Tumour specimen available (FFPE) R 1:1 No crossover 1 2 prior lines of chemo including 1 line of platinum chemo Docetaxel 75mg/m2 q3w PD All PD-L1 status allowed (N=850 enrolled) Stratification factors PD-L1 IC expression (0 vs 1 vs 2 vs 3) Histology (squamous vs nonsquamous) Primary endpoints (first 850 enrolled patients) OS in ITT population OS in patients with 1% PD-L1 expression (TC1/2/3 or IC1/2/3) Secondary endpoints ORR, PFS, and DoR Safety 26% SqCC Prior chemotherapy regimens (1 vs 2) Rittemeyer Lancet 17

38 Overall Survival, % OAK study: OS ITT (N = 850) Atezolizumab Docetaxel 12-mo OS 55% 41% Median 13.8 vs 9.6 mo HR, 0.73 a (95% CI, 0.62, 0.87) P =.0003 Minimum follow-up = 19 months 18-mo OS 40% 27% Months a Stratified HR Rittemeyer Lancet 17

39 Overall survival (%) Overall survival (%) OAK: OS by histology non-squamous ITT (n=628) Atezolizumab Docetaxel Minimum follow-up 19 months Landmark OS 12 month 59% 46% Landmark OS 18 month 44% 31% Median OS, mo (95% CI) 15.6 (13.3, 17.6) 11.2 (9.3, 12.6) HR (95% CI) 0.73 (0.60, 0.89); P= squamous ITT (n=222) Atezolizumab Docetaxel Minimum follow-up 19 months Landmark OS 12 month 42% 29% Landmark OS 18 month 30% 16% Median OS, mo (95% CI) 8.9 (7.4, 12.8) 7.7 (6.3, 8.9) HR (95% CI) 0.73 (0.54, 0.98); P= Atezolizumab Docetaxel Atezolizumab Docetaxel Median 11.2 mo (95% CI, 9.3, 12.6) Median 15.6 mo (95% CI, 13.3, 17.6) Median 7.7 mo (95% CI, 6.3, 8.9) Median 8.9 mo (95% CI, 7.4, 12.8) Time (months) Time (months) Rittmeyer, et al. Lancet 2016; Barlesi, et al. ESMO 2016 (abstr LBA44); Roche data on file

40 OAK: OS HR by histology and PD-L1 Subgroup Non-squamous TC3 or IC3 TC2/3 or IC2/3 TC1/2/3 or IC1/2/3 TC0 and IC0 All non-squamous n (%) 96 (15%) 188 (30%) 333 (53%) 290 (46%) 628 (100%) HR Median OS, mo Atezolizumab Docetaxel Squamous TC3 or IC3 TC2/3 or IC2/3 TC1/2/3 or IC1/2/3 TC0 and IC0 All squamous 41 (18%) 77 (35%) 130 (59%) 89 (40%) 222 (100%) ITT In favour of atezolizumab Hazard Ratio In favour of docetaxel Gadgeel, et al. WCLC 2016 (abstr PL04a.02)

41 KEYNOTE-024: First Line Pembrolizumab A Phase III, randomized, open-label study of pembrolizumab vs platinum-doublet chemotherapy as firstline therapy in patients with advanced or metastatic NSCLC that expresses PD-L1 in 50% of tumor cells Pembrolizumab 200 mg Q3W Key Inclusion Criteria (2 years) Advanced, previously untreated NSCLC PD-L1+ tumor expression 50% No EGFR sensitizing mutation or ALK translocation ECOG PS 1 R 1:1 Optional crossover after disease progression Investigator choice of platinum-based chemotherapy 50% N=305 For 4 6 cycles Primary endpoint: PFS (RECIST v1.1 per blinded, independent central review) Secondary endpoints: ORR, OS, safety, and tolerability Exploratory endpoint: DOR 19% SqCC Reck M et al. N Engl J Med. 2016

42 PFS, % OS, % KEYNOTE-024: PFS and OS (PD-L1 50%) Events, n Median, mo HR (95% CI) P Events, n Median, mo HR (95% CI) P Pembro Chemo ( ) <0.001 Pembro 44 NR 0.60 Chemo 64 NR ( ) % 72% 70% 54% % 50% 48% 15% Time (months) Time (months) Reck M et al. N Engl J Med. 2016

43 KEYNOTE-024: PFS in Subgroups Reck M et al. N Engl J Med. 2016

44 New strategies for SqCC-NSCLC Trial Eligibility N /EP Bio-marker Study Arms Roche IMpower-131 Stage IIIB/IV Squamous, MSD KN-407 Stage IV, Squamous Roche IMpower Stage IIIB/IV, Chemonaïve SCC/non-SCC AZ MYSTIC Stage IIIB/IV SCC/non-SCC AZ NEPTUNE Stage IIIB/IV SCC/non-SCC BMS CM-227 Stage IIIB/IV, SCC/non-SCC 1200 PFS 560 PFS/OS 570 PFS/OS 675 PFS 800 OS 1980 PFS/OS All corners 1. Atezo+ Carbo/taxol_ Atezo man 2. Atezo+ Carbo/ Nab-paclitaxel_ Atezo man 3. Carbo/ Nab-paclitaxel All corners 1. Pembro + Carboplatin/ Nabpaclitaxel/taxol 2. Carboplatin/ Nab-paclitaxel/taxol PD-L1 expression (TC or IC 1% [TC1/2/3 or IC1/2/3]) Collected, not defined for eligibility Collected, not defined for eligibility 1. Atezo 2. Chemo 1. Durva + Treme 2. Durva 3. Chemo 1. Durva + Treme 2. Chemo PDL1 positive 1. Nivo 2. Nivo + Ipi 3. Nivo + Chemo 4. Chemo NCT Phase I Safety 1. Pembro + Necitumumab 4 8

45 ESMO Guidelines for Advanced Stage IV SCC Silvia Novello, ESMO Guidelines, Annals of Oncol 2016

46 ESMO Guidelines for Advanced Stage IV SCC Silvia Novello, ESMO Guidelines, Annals of Oncol 2016

47

48 * Nectimumumab and afatinib not recommended in updated NCCN

49 New Algorism for SqCC Lung Cancer Treatment OS HR 0.35 OS HR 0.35 Necitumumab??? OS HR 0.84 OS HR 0.59, 0.74, 0.73 OS HR 0.59, 0.74, 0.73 HR 0.88 HR 0.88 Afatinib??? OS HR 0.81 Yi-Chen Zhang, ESMO open 2016

50 THANK YOU!!!

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