Melanoma. Il parere dell esperto. V. Ferraresi. Divisione di Oncologia Medica 1

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1 Melanoma Il parere dell esperto V. Ferraresi Divisione di Oncologia Medica 1

2 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA trial) AND TARGET THERAPY (BRIM8 and COMBI-AD trials).the immediate future IMMUNOTHERAPY..two is always better than one??.. the goal is (again) the CR!!. new targets!! COMBO TARGET THERAPY (COLUMBUS) a confirmation lesser toxicity? COMBO IMMUNO/TARGET THERAPIES.the future???

3 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA ) AND TARGET THERAPY (BRIM8, COMBI-AD)..the immediate future IMMUNOTHERAPY..two is always better than one??.. the goal is (again) the CR!! new targets!! COMBO TARGET THERAPY (COLUMBUS) a confirmation lesser toxicity? COMBO IMMUNO/TARGET THERAPIES.the future???

4 ESMO 2017 and MELANOMA IPI10 vs NIVO3 DABR+TRAM vs placebo VEM vs placebo

5

6 OS data immature BRAF mutated pts: about 40% CA COMBI-AD

7 SUBGROUP ANALYSES COMBI-AD CA

8 EORTC No stratification according to BRAF status HR= 0.86, CI ; P < HR = 0.90, CI ; P = 0.003

9 Only IIIB/IIIC patients

10 Checkmate-238 Nivolumab vs Ipilimumab

11 Is adjuvant checkpoint blockade after resection necessary or it should be reserved wiht the hope of equal benefit for patients who have a relapse with unresectale disease after surgery for stage III or IV melanoma.??

12 CheckMate 915 An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma (NCT ) IPI alone arm eliminated Recruiting Italy partecipation pending.

13 ESMO 2017 MELANOMA ADJUVANT THERAPY with CHECKPOINT INHIBITORS AND TARGET THERAPY Differences in population characteristics (stage, BRAF status): comparisons methodologically not correct BRAF inhibitors alone: is there a future??? BRAFi/MEKi combo (COMBI-AD trial): clear RFS, DMFS and OS benefit in all stages. The new standard for BRAF mutated patients? anti-pd1: Pending OS data q2wks NIVO vs q3wks flat PEMBRO End of adjuvant IPI10mg/kg (FDA approval): more toxic and less active than NIVO, light dose in combo with NIVO in ongoing trials Neoadjuvant + adjuvant treatment with combo immuno or combo target therapy high % of ORR (80-100%) and pcr (40-50%) improve locoregional control?? avoid TLND in pts with palpable nodes??

14 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA trial) AND TARGET THERAPY (BRIM8 andcombi-ad trials)..the immediate future IMMUNOTHERAPY..two is always better than one??.. the goal is (again) the CR!!. new targets!! COMBO TARGET THERAPY (COLUMBUS) a confirmation lesser toxicity? COMBO IMMUNO/TARGET THERAPIES.the future???

15 CheckMate 067 (ESMO2017) 17

16 CheckMate 067 (ESMO2017)

17 CA BRAF mutated pts: 31-32%

18 CA

19 Three-year overall survival data based on PD-L1 expression using time-dependent ROC for censored survival data Area- under-the-curve values, as compared with 0.5 (the line of no discrimination), were 0.56 (95% CI, 0.49 to 0.63) in the nivolumab-plus-ipilimumab group (P = 0.09) and 0.57 (95% CI, 0.50 to 0.63) in the nivolumab group (P = 0.04), which indicate that the level of tumor PD-L1 expression alone is a poor predictive biomarker of overall survival

20 NIVOLUMAB/IPILIMUMAB combo What to say awaiting the regimen? PD-L1: starting point for discussion with patients for combo IPI/NIVO versus NIVO (if we don t need the response to palliate symptoms and if you have favorite sites of disease ) BRAF mutation status and combo immunotherapy IPI/NIVO: we need more data on patients characteristics (bias of selection?) no head-to-head comparison versus combo target therapy role of subsequent lines of therapy toxicity as a point for discussion with patients (% G3-4 toxicities)

21 Classifying Cancers Based ont-cell Infiltration and PD-L1 - Melanoma ~40% ~40% ~20% ~1% Teng MWL, Cancer Research 2015

22 Potential Role of LAG-3 in T-Cell Exhaustion and Anti PD-1 Resistance LAG-3 regulates a checkpoint pathway that limits the activity of T cells 1 LAG-3 and PD-1 receptors are overexpressed and/or coexpressed on tumor-infiltrating lymphocytes in melanoma 2,3 I-O therapy naive: LAG-3 may limit I-O response + Nivolumab + Relatlimab PD-1 PD-L1 Tumor or other infiltrating cell Effector CD4 + /CD8 + T cell I-O therapy experienced: LAG-3 may contribute to resistance + Antigen LAG-3 PD-1 MHC II +Nivolumab Acquired resistance PD-L1 PD-1 MHC II LAG-3 + Nivolumab + Relatlimab Nivolumab Relatlimab (BMS /anti LAG-3) I-O, immuno-oncology; MHC II, major histocompatibility complex class II; PD-1, programmed death-1; PD- L1, programmed death ligand Grosso JF et al. J Clin Invest. 2007;117: Goding SR et al. J Immunol. 2013;190: Taube JM et al. Clin Cancer Res. 2015;21:

23 Relatlimab (anti-lag3) + Nivolumab PD-1/PD-L1 resistant/refractory melanoma pts Mel Prior PD-(L)1 a t All Patients a N = 270 ORR, n (%) c All n = 61 7 (11.5) d 95% CI 4.7, 22 BOR, n (%) c LAG-3 1% b n = 33 6 (18) d 7, 35.5 CR 1 (1.6) 1 (3.0) PR 6 (9.8) d 5 (15) d SD 23 (38) 15 (45) PD 25 (41) 8 (24) Clinical progression e 6 (9.8) 4 (12) DCR (CR + PR + SD), n (%) c 30 (49) 95% CI 36, (64) 45, 80 PD1/PD-L1 resistant patients (46% PD as best response, 77% > 2 prior lines) Any Grade n (%) Grade 3 4 n (%) Any TRAE b 137 (51) 27 (10) TRAEs in 5% of patients Fatigue 30 (11) 0 Pruritus 19 (7.0) 0 Diarrhea 18 (6.7) 3 (1.1) Arthralgia 17 (6.3) 0 Infusion-related reaction 15 (5.6) 0 Any serious TRAE b 18 (6.7) 12 (4.4) Serious TRAEs in > 1 patient Colitis 4 (1.5) 3 (1.1) Pneumonitis 2 (0.7) 2 (0.7) Myocarditis c 2 (0.7) 0 Pyrexia 2 (0.7) 0 Any TRAE leading to discontinuation b 11 (4.1) 8 (3.0) LAG-3 expression ( 1%) enriched for response Median duration of response was not reached (range, 0.1+ to 39+) 35

24 Best percent change in sum of target RELATLIMAB PD-1/PD-L1 resistant/refractory melanoma pts Best Change in Target Lesion Size by LAG-3 and PD-L1 Expression lesion diameters from baseline a,b LAG-3 1% n = 29 45% with tumor reduction LAG-3 < 1% n = 17 24% with tumor reduction LAG-3 Unknown n = 8 13% with tumor reduction Pink: PD-L1 1% Blue: PD-L1 < 1% Gray: PD-L1 unknown a Six patients with clinical progression prior to their first scan and 1 with PD due to a new symptomatic brain metastasis prior to getting full scans were not included. b One patient with best change from baseline > 30% had a best response of SD. 37

25 ECHO-202/KEYNOTE-037 BRAF mut: 29%; M1c; 55%; Liver: 40%

26

27 ECHO-301/KEYNOTE 352 phase III trial ongoing (fully accrued)

28 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA trial) AND TARGET THERAPY (BRIM8 andcombi-ad trials) the immediate future IMMUNOTHERAPY..two is always better than one??.. the goal is (again) the CR!!. new targets!! COMBO TARGET THERAPY (COLUMBUS) a confirmation lesser toxicity? COMBO IMMUNO/TARGET THERAPIES.the future???

29

30 COLUMBUS ESM Lower incidence of pyrexia and dermatological toxicity - Higher incidence of hepatic toxicity not confirmed in phase III trial COMBI-d 1 COMBI-v 2 cobrim 3 Dabrafenib + Dabrafenib + Vemurafenib + Study Agent(s) Dabrafenib Vemurafenib Vemurafenib Trametinib Trametinib Cobimetinib Patients, n (study arm) BRAF + MEK 209 Inhibitor 211 Combination 350 Treatment AEs of interest, % CuSCC/KA Phase 3 Studies: 2 Adverse 9 Events of 1 Special Interest Skin papilloma Hyperkeratosis Photosensitivity reaction Decreased ejection fraction Hypertension Chorioretinopathy < 1 < 1 1 < 1 12 < 1 Hand-foot syndrome b Increased ALT Increased AST Retinal detachment QT interval prolongation

31 (1% due to tox)

32

33

34 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA trial) AND TARGET THERAPY (BRIM8 andcombi-ad trials) the immediate future IMMUNOTHERAPY..two is always better than one??.. the goal is (again) the CR!! new targets!! COMBO TARGET THERAPY (COLUMBUS) a confirmation lesser toxicity? COMBO IMMUNO/TARGET THERAPIES.the future???

35 TARGETED THERAPIES AND IMMUNOTHERAPIES HOW TO USE THESE AGENTS TOGETHER? SEQUENCES??? after progression? at predefinite time? METASTATIC MELANOMA BRAF MUTATED DISEASE CONCURRENT COMBINATIONS???

36 BRAF inhibitors and immune system

37

38

39

40

41 KEYNOTE022 Phase 2: Combination Pembrolizumab + Dabrafenib + Trametinib Study Design Key eligibility criteria Unresectable or metastatic stage IV BRAF V600E/K mutant melanoma No prior therapy ECOG performance status 0-1 N = 120 Randomised 1:1 Stratified by: ECOG performance status (0 vs 1) LDH: > 1.1 ULN vs 1.1 ULN Pembrolizumab 2 mg/kg Q3W + dabrafenib 150 mg BID + trametinib 2 mg QD Placebo Q3W + dabrafenib 150 mg BID + trametinib 2 mg QD Treatment until disease progression, intolerable toxicity, investigator decision, or (for pembrolizumab) 24 months a Primary endpoint: PFS Secondary endpoints: ORR, DOR, OS ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; ULN, upper limit of normal. a Patients experiencing a confirmed CR after 6 months may discontinue pembrolizumab after receiving 2 doses beyond initial CR but may continue treatment with dabrafenib and trametinib. Long GV, et al. J Clin Oncol. 2016;34(suppl) [abstract TPS9596].

42 Different Profiles of Treatment: Facts on Efficacy Immunotherapies: Limited by non-responders Long-term plateau of OS demonstrated for anti-ctla4 and anti-pd-1 Efficacy possible beyond discontinuation No condition identified for efficacy (PD-L1)? Targeted therapies: Efficacy conditioned on mutation BRAF 3 years OS plateau demonstrated for D T Limited by resistance No clear demonstration that can be discontinued So far No predictive marker for choice of frontline treatment No marker for safe discontinuation No marker for best selection of combination, or order of sequencing (ONGOING TRIALS) Optimal scheduling for combo immunotherapies awaiting (IPI light )

43 Different Profiles of Treatment: Perceptions... Truth is different than perception Immunotherapies: Natural : exploit endogenous immune system to eradicate cancer Slow Exclude fast progressions Long response Targeted therapies: All treatments are less active when the disease is aggressive and fast (eg, high LDH) Artificial : precision/perzonalized medicine Fast Anti-PD-1+CTLA4 inhibitors work nearly as fast as targeted therapies More active in case of fast progression Resistance sooner or later Targeted therapies can provide very long survival Different profiles of toxicities ( and combo TT/IT) What to do? AWAIT THE RESULTS OF CLINICAL TRIALS! Outside an investigational trial we must still be guided by patients and disease characteristics

44 Melanoma treatment Grazie

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