Melanoma: From Chemotherapy to Targeted Therapy and Immunotherapy. What every patient needs to know. James Larkin
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1 Melanoma: From Chemotherapy to Targeted Therapy and Immunotherapy What every patient needs to know James Larkin
2 Melanoma Therapy Surgery 1846 Cytotoxic Chemotherapy 1946 Checkpoint Inhibitors Ipilimumab 2011 Nivolumab 2014 Pembrolizumab 2014 Radiation Therapy 1901 Cytokines Interferon-α 1995 Interleukin Targeted Therapies Vemurafenib 2011 Trametinib 2013 Dabrafenib 2013 Cobimetinib 2015
3 Melanoma Therapy Surgery 1846 Cytotoxic Chemotherapy 1946 Checkpoint Inhibitors Ipilimumab 2011 Nivolumab 2014 Pembrolizumab 2014 Radiation Therapy 1901 Cytokines Interferon-α 1995 Interleukin Targeted Therapies Vemurafenib 2011 Trametinib 2013 Dabrafenib 2013 Cobimetinib 2015
4 Historical survival of stage 4 melanoma: median 6-9 months 5- year survival Skin, LNs 25% Lung 15% Liver 10% 5- year survival LDH 25 vs 10% normal vs high Balch JCO 2009
5 Targeted Therapies
6 NRAS RTK e.g. KIT RAF BRAF V600E MEK ERK Abnormal Cellular Cellular Proliferation KIT ~ 2% BRAF ~ 40% NRAS ~ 20% GNAQ ~ 2% Curtin NEJM 2005; Curtin JCO 2006
7 The story starts here
8 The story starts here Davies Nature 2002
9 and continues here Chapman NEJM 2011
10 BRIM-3: Tumour shrinkage Chapman NEJM 2011
11 More about chemotherapy: CM 037 Larkin JCO in press
12 More about chemotherapy: CM 037 Larkin JCO in press
13 BRIM-3: Progression free survival Median PFS 5.3 vs 1.6 months Chapman NEJM 2011
14 BRAFi + MEKi vs BRAFi vemurafenib + cobimetinib vs vemurafenib Larkin NEJM 2014
15 BRAFi + MEKi vs BRAFi: 3 RCTs Trial Dabrafenib + trametinib vs vemurafenib 1 Dabrafenib + trametinib vs dabrafenib 2 Vemurafenib + cobimetinib vs vemurafenib 3 Progression Free Survival medians 11.4 vs 7.3 mos HR 0.56, p< vs 8.8 mos HR 0.75, p= vs 6.2 mos HR 0.51, p< Robert NEJM 2015 Long NEJM 2014 Larkin NEJM 2014
16 17 year old with advanced melanoma
17 17 year old with advanced melanoma
18 Day 9 BRAF inhibitor therapy
19 Day 9 BRAF inhibitor therapy
20 NRAS RTK e.g. KIT RAF BRAF V600E MEK ERK Abnormal Cellular Cellular Proliferation KIT ~ 2% BRAF ~ 40% NRAS ~ 20% GNAQ ~ 2% Curtin NEJM 2005; Curtin JCO 2006
21 Challenges for Targeted Therapy
22 Challenges for Targeted Therapy RESISTANCE TO TREATMENT
23 Checkpoint Inhibitors
24 Interferon Immune stimulation +++ Interleukin 2
25 Interferon Immune stimulation +++ Interleukin 2 CTLA Immune checkpoint inhibitors PD1
26 Mellman Nature 2012
27 Proportion Alive 5-year OS analysis DTIC +/- ipilimumab DTIC + 10 mg/kg Ipi Censored DTIC + Placebo Censored Months Treatment group Median OS, months Overall survival rate, % 1-year 2-year 3-year 4-year 5-year Ipi + DTIC % 28.9% 21.3% 19.1% 18.2% Plac + DTIC % 17.8% 12.1% 9.7% 8.8% PLATEAU
28 The Guardian February 2016: The closest thing yet to a cure for terminal cancer?
29 CA : Study Design CA : Study Design Randomized, double-blind, phase III study to compare NIVO+IPI or NIVO alone to IPI alone* Stratify by: N=314 NIVO 1 mg/kg + IPI 3 mg/kg Q3W for 4 doses then NIVO 3 mg/kg Q2W Unresectable or Metatastic Melanoma Previously untreated 945 patients Randomize 1:1:1 BRAF mutation status AJCC M stage Tumor PD-L1 expression <5% vs 5%* N=316 NIVO 3 mg/kg Q2W + IPI-matched placebo Treat until progression or unacceptable toxicity Co- Primary endpoints: PFS and OS vs IPI Secondary endpoints: ORR, NIVO vs NIVO+IPI (OS and PFS)*, Safety N=315 IPI 3 mg/kg Q3W for 4 doses + NIVO-matched placebo Database lock: Sept 13, 2016 (median follow-up ~30 months in both NIVO-containing arms) *The study was not powered for a comparison between NIVO and NIVO+IPI Larkin AACR 2017
30 Progression-free Percentage Survival of PFS (%) Updated Progression-Free Survival 100 NIVO+IPI (N=314) NIVO (N=316) IPI (N=315) 90 Median PFS, months (95% CI) 11.7 ( ) 6.9 ( ) 2.9 ( ) 80 HR (95% CI) vs. IPI 0.42 ( ) 0.54 ( ) HR (95% CI) vs. NIVO 0.76 ( ) % 43% 43% 30 37% 20 NIVO+IPI 10 NIVO 18% IPI 12% Months Number of patients at risk: NIVO+ IPI NIVO IPI Database lock: Sept 13, 2016
31 Updated Response To Treatment NIVO+IPI (N=314) NIVO (N=316) IPI (N=315) ORR, % (95% CI)* 58.9 ( ) 44.6 ( ) 19.0 ( ) Best overall response % Complete response Partial response Stable disease Progressive disease Unknown Median duration of response, months (95% CI) NR (NR NR) 31.1 (31.1 NR) 18.2 (8.3 NR)
32 Overall Percentage Survival of PFS (%) Overall Survival NIVO+IPI (N=314) NIVO (N=316) IPI (N=315) Median OS, months (95% CI) NR NR (29.1 NR) 20.0 ( ) % HR (98% CI) vs. IPI 0.55 ( ) 0.63 ( ) -- HR (95% CI) vs. NIVO 0.88 ( ) % 67% 64% 59% 45% NIVO+IPI NIVO IPI Months Number of patients at risk: NIVO+IPI NIVO IPI Database lock: Sept 13, 2016
33 Subsequent Therapies: All Randomized Patients NIVO+IPI (N=314) NIVO (N=316) IPI (N=315) Any subsequent therapy, n (%)* 129 (41) 169 (54) 225 (71) Systemic therapy 100 (32) 140 (44) 196 (62) Anti-PD-1 agents 30 (10) 32 (10) 132 (42) Anti-CTLA-4 19 (6) 83 (26) 12 (4) BRAF inhibitors 40 (13) 57 (18) 68 (22) MEK/NRAS Inhibitors 30 (10) 38 (12) 39 (12) Investigational agents** 8 (3) 6 (2) 15 (5) Median time to subsequent systemic therapy, mo (95% CI) 2 year % of pts free of subsequent therapies NR (NR NR) 26.8 (18.0 NR) 8.5 ( )
34 PFS and OS Subgroup Analyses (All Randomized Patients) Descriptive comparison between NIVO+IPI and NIVO Patients Unstratified Hazard Ratio Unstratified Hazard Ratio (95% CI) Subgroup NIVO+IPI NIVO PFS OS PFS OS Overall <65 years years BRAF Mutant BRAF Wild-type ECOG PS = ECOG PS = M0/M1a/M1b M1c LDH ULN LDH > ULN LDH > 2 x ULN PD-L1 5% PD-L1 <5% NIVO+IPI NIVO NIVO+IPI NIVO 2
35 OS (%) OS (%) OS in Patients with Wild-type BRAF and BRAF Mutations BRAF Wild-type BRAF Mutant NIVO+IPI NIVO IPI NIVO+IPI NIVO IPI 100 Median, mo (95% CI) NR (27.6 NA) NR (25.8 NR) 18.5 ( ) 100 Median, mo (95% CI) NR NR (26.4 NR) 24.6 ( ) HR (95% CI) vs NIVO 0.97 ( ) 61% 57% HR (95% CI) vs NIVO 0.71 ( ) 71% 62% 51% % NIVO+IPI NIVO IPI Months Number of patients at risk: NIVO+IPI NIVO+IPI NIVO IPI Months Number of patients at risk: NIVO+IPI NIVO NIVO IPI IPI
36 OS (%) OS (%) OS by Tumor PD-L1 Expression, 5% Cutoff Tumor PD-L1 Expression Level <5% Tumor PD-L1 Expression Level 5% Median OS, mo (95% CI) HR (95% CI) vs NIVO NIVO+IPI NIVO IPI NR (31.8 NR) 0.84 ( ) NR (23.1 NR) 18.5 ( ) Median OS, mo (95% CI) HR (95% CI) vs NIVO NIVO+IPI NIVO IPI NR 1.05 ( ) NR 28.9 (18.1 NR) % % 55% % 54% 30 41% NIVO+IPI NIVO IPI Months Number of patients at risk: NIVO+IPI NIVO IPI Months Number of patients at risk: NIVO+IPI NIVO IPI
37 Response to Treatment by Tumor PD-L1 Expression NIVO+IPI NIVO IPI PD-L1 ( 5%) PD-L1 (<5%) ORR, % (95% CI) Median Duration of Response (months) ORR, % (95% CI) Median Duration of Response (months) 73.5 ( ) 58.8 ( ) 21.3 ( ) NR NR NR 56.2 ( ) 42.3 ( ) 17.8 ( ) NR NR 18.2
38 Safety Summary Updated safety information, with an additional 19 months of follow-up, was consistent with the initial report (Larkin et al. NEJM 2015;373:23 34) NIVO+IPI (N=313) NIVO (N=313) IPI (N=311) Patients reporting event, % Any Grade Grade 3-4 Any Grade Grade 3-4 Any Grade Grade 3-4 Treatment-related adverse event (AE) Treatment-related AE leading to discontinuation Treatment-related death, n (%) 2 (0.6) a 1 (0.3) b 1 (0.3) b ORR was 70.7% for pts who discontinued NIVO+IPI due to AEs, with median OS not reached a Cardiomyopathy (NIVO+IPI, N=1); Liver necrosis (NIVO+IPI, N=1). Both deaths occurred >100 days after the last treatment. b Neutropenia (NIVO, N=1); colon perforation (IPI, N=1). Most select AEs were managed and resolved within 3-4 weeks (85 100% across organ categories)
39 What information do we need to select patients for targeted and immunotherapies? Therapy schedule Disease tempo Chance of success Patient preference Disease distribution Performance status Need for rapid response Adverse events
40
41 Adjuvant Ipilimumab in Melanoma
42 Summary Advanced melanoma historically regarded as generally untreatable with drugs Targeted therapy a major innovation in cancer therapeutics based on understanding biology Resistance generally inevitable in advanced disease though after less than a year on average Immune checkpoint inhibitors generally well tolerated and active in multiple tumour types Anti-CTLA4 therapy probably curative in a small number of patients with advanced melanoma Lots of work still to do; I hope the last 5 years are just the beginning
43 Acknowledgements Our patients and their families Melanoma Clinical Trials Team, Royal Marsden, led by Sister Kim Edmonds Samra Turajlic and Martin Gore Collaborators in the UK and internationally in industry, academia and advocacy groups
44 Thank you
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