Innovations in Immunotherapy - Melanoma. Systemic Therapies October 27, 2018 Charles L. Bane, MD

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1 Innovations in Immunotherapy - Melanoma Systemic Therapies October 27, 2018 Charles L. Bane, MD

2 Melanoma Prognosis Survival at 10 years Stage I: 90% Stage II: 60% Stage III: 40% Stage IV: 10% 2

3 Indications for Systemic Therapy Adjuvant Administered after primary therapy (surgery) Curative intent/prevent disease recurrence Increase disease-free/overall survival Metastatic Administered as primary therapy Palliative intent Increase duration and quality of life 3

4 Classes of Systemic Therapy for Malignancy Hormonal Cytotoxic chemotherapy Molecular Targeted agents Immunotherapy 4

5 Chemotherapy for Melanoma Dacarbazine Approved for stage IV disease 1975 Response rate 15%, Duration ~4 months Temozolomide Oral form of Dacarbazine Response in brain metastasis 7% Bio-chemotherapy Multi-agent therapy (toxic) Response 30%, short duration 5

6 Targeted Therapy for Melanoma BRAF inhibition Mutation present ~50% melanoma V600E most common Important driver of proliferation MEK inhibition Escape mechanism for resistance 6

7 Normal cell Melanoma cell 7

8 Targeted Therapy for Melanoma Response Rate Progression free 6 month Survival Vemurafenib 48.6% 5.3 months 84% Dacarbazine 5.5% 1.6 months 64% Chapman,NEJM,

9 9

10 Targeted Therapy for Melanoma Response Rate Progression Free PFS at 12 months Dabrafenib 54% 5.6 months 9% Dabrafenib + Trametanib 76% 10.5 months 41% Flaherty, NEJM,

11 Immunotherapy for Melanoma Rationale High mutational burden in Melanoma Clinical Observations Spontaneous regressions Late relapses (>10 years) Immunotherapy mechanisms Activate anti-tumor response Dis-inhibit anti-tumor response Clinical efficacy Relatively low response rate Durable responses/possible cures 11

12 12

13 Immunotherapy for Melanoma High Dose Interleukin-2 Approved for stage IV melanoma 1998 RR~15%, Complete response ~6% Duration of response for CR >5 years Extremely toxic Interferon-alpha Approved for stage III 1996 (adjuvant) Toxic Benefit controversial 13

14 14

15 Immunotherapy for Melanoma Ipilimumab Antibody against CTLA4 Dis-inhibits anti-tumor response Low response rate Some responses durable (cure?) Autoimmune toxicity Common, unpredictable, potentially severe 15

16 16

17 17

18 Immunotherapy for Melanoma Pembrolizumab and Nivolumab Anti-PD L1 antibodies Dis-inhibits anti-tumor response Relatively higher response rates Durable responses Autoimmune toxicity Uncommon, manageable 18

19 Immunotherapy for Melanoma Response Rate Complete Response Nivolumab 40% 8% 45% Dacarbazine 14% 1% 10% One Year survival Robert, NEJM,

20 20

21 Immunotherapy for Melanoma Nivolumab plus Ipilimumab Response Rate Median Duration of Response 60% Not Reached 55% Nivolumab 45% 31 months 16% Ipilimumab 19% 18 months 27% Grade 3-4 toxicity Larkin, NEJM,

22 22

23 Adjuvant Therapy for Melanoma Stage III disease/stage IV completely resected Interferon-a Questionable benefit Ipilimumab (high dose) Severe toxicity Nivolumab Greater efficacy, lower toxicity Dabrafenib plus Trametinib (BRAF positive only) Durability of response? 23

24 Systemic Therapy for Metastatic Melanoma Ipilimumab plus Nivolumab High response, potentially durable High toxicity Nivolumab or Pembrolizumab (alone) High response, potentially durable Well tolerated Dabrafenib/Trimetinib or vem/cob Rapid response, CNS response, well tolerated Not durable 24

25 Current State of Systemic Therapy for Malignant Melanoma Era of significant progress in development of systemic therapies Expanding options for prevention and treatment of systemic disease Enhanced efficacy Manageable toxicity 25

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