Melanoma: Therapeutic Progress and the Improvements Continue
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1 Melanoma: Therapeutic Progress and the Improvements Continue David W. Ollila, MD Professor of Surgery Jesse and James Millis Professor of Melanoma Research May 20, 2016 Disclosures: NONE
2 Outline 2016 Therapeutic options: Stage IV patients» Systemic» Surgical Therapeutic options: Stage III patients» Systemic» Surgical Sentinel Node Update 5/19/2016 2
3 Stages IIIbc IV Metastatic Melanoma 5/19/2016 3
4 US FDA Approved Stage IV Systemic Therapy Options Dacarbazine (1970s)» Complete Response 3-5% Interleukin-2 (1998)» Complete Response 7-8% US FDA Approved Stage III Systemic Therapy Options Interferon alpha-2b (1995)» Disease-free but no overall survival advantage
5 Somatic Mutations in Melanoma COSMIC Database April 2012
6 A. B-RAF Oncogenic Addiction in Melanoma is Bad C. PTEN Loss B. B-RAF N-RAS Long J Clin Oncol 2011 Jacob Cancer 2012 Nathanson ASCO 2011
7 B-Raf Inhibitors (B-RAFi; e.g. vemurafenib, dabrafenib) Prolong Survival in B-RAF V600E/(K) Melanoma Chapman ASCO 2012 Hauschild ASCO 2012
8 MEK inhibitors (MEKi) Have Clinical Benefit in B-RAF V600E/K Melanoma that is Smaller Than That of B-RAFi Flaherty N Engl J Med 2012
9 Checkpoint Blockade -Inhibiting the Inhibitors Tumor? Pardoll Nat Rev Cancer 2012
10 Differences in Checkpoint inhibitors 5/19/2016 Ribas N Engl J Med
11 Ipilimumab Prolongs Survival 10.1 vs. 6.4 months, HR 0.66 Hodi et al NEJM 2010
12 PD-1 Inhibitory Antibodies (BMS936558, MK3475) Topalian N Engl J Med 2012
13 Combination Checkpoint Inhibitors 5/19/2016 Larkin J N Engl J Med Jul 2;373(1):
14 US FDA Approved Stage IV Systemic Therapy Options Ipilimumab (2011)» 10.1 vs. 6.4 months, HR 0.66 Vemurafenib (2011)» 13.6 vs. 9.7 months, HR 0.70 Dabrafenib (2013)» PFS 5.1 vs 2.7 months HR 0.33 Trametinib (2014)» Combination for BRAF mutant
15 US FDA Approved Stage IV Systemic Therapy Options Pembrolizumab (2014)» Response Rate 26% Nivolumab (2014)» RR 40% vs 14% p<0.001» One yr survival 72% vs 42% Combinations..
16 US FDA Approved Stage IV Systemic Therapy Options Nivolumab + Ipilimumab (2015)» Untreated Stage IV melanoma» Nivo + Ipi vs Nivo vs Ipi» RR 57% vs 43% vs 19% p<0.001» Median survival not yet published» Side Effects: colitis, diarrhea, pyrexia, pneumonitis Larkin J N Engl J Med Jul 2;373(1):23-34
17 M1a M1b M1c Surgical Options Complete metastasectomy» Surgical removal of all radiographic and clinical stage IV disease» Curative intent Incomplete metastasectomy» Partial removal of radiographic and clinical stage IV disease» Palliative intent
18 Stage IV AJCC Stage IV Melanoma* M1a: Skin, soft tissue or distant lymph nodes M1b: Pulmonary M1c: All other visceral sites Median Survival Range (mos) 5-Yr OS Range (%) M1a (n=728) M1b (n=698) M1c (n=395) *Complete metastasectomy Non-randomized data
19 A phase 2 trial of complete resection for Stage IV melanoma: Results of SWOG S patients were enrolled from 18 different centers. The primary analysis included 64 completely resected patients. Twenty patients (31%) had visceral disease. Median overall survival was 21 months (95% CI, months). Overall survivals at 3 and 4 years were 36% and 31%, respectively 5/19/2016 Cancer pp , 15 October
20 Metastasectomy for Distant Metastatic Melanoma: Analysis of Data from the First Multicenter Selective Lymphadenectomy Trial 291 patients with stage IV recurrence, 161 (55 %) underwent surgery with/without systemic therapy Median survival: 15.8 vs. 6.9 months 4-year survival: 20.8 vs. 7.0% (p < ; HR 0.406) M1a median > 60 vs months, p = M1b median 17.9 vs. 9.1 months, p = 0.11 M1c median 15.0 vs. 6.3 months p = /19/2016 Ann Surg Oncol Aug;19(8):
21 Holy Grail for Stage IV Melanoma: Surgical Resection + Adjuvant Therapy Randomized, double-blind, placebo-controlled phase 3 trial Accrual Goal Primary endpoint: Overall Survival Note: E1609 addresses NED M1a and M1b disease Surgical Resection Rendering Patient NED Stratification Factors Number of individual lesions: 1, 2-3, 4-5 Site of mets: M1a: softtissue & nodal mets M1b: visceral mets R A N D O M I Z E Novel Agent(s) Placebo? Ipi? BRAF inhibitor?
22 Holy Grail for Stage IV Melanoma: Neoadjuvant Therapy + Surgical Resection Randomized, double-blind, placebo-controlled phase 3 trial Accrual Goal: Small numbers Primary endpoint: Pathologic Complete Response Note: Neoadjuvant trials address NED IIIc M1ab disease Stratification Factors Number of individual lesions: 1, 2-3, 4-5 Site of mets: M1a: softtissue & nodal mets M1b: visceral mets R A N D O M I Z E Novel Agent(s) Checkpoint inhibitors? Targeted inhibitors? Surgical Resection Rendering Patient NED
23 Outline 2015 Therapeutic options: Stage IV patients» Systemic» Surgical Therapeutic options: Stage III patients» Systemic» Surgical Sentinel Node Update 5/19/
24 Stage IIIc IV M1a Metastatic Melanoma 5/19/
25
26 Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. Eligible: Unresectable IIIb, IIIc, M1a, M1b, M1c R A N D O M I Z E TVEC GMC-SF Primary outcome: Durable response rate Secondary outcome: Overall survival Andtbacka RH, Kaufman HL, Collichio F, et al., J Clin Oncol Sep 1;33(25): /19/
27 Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. Andtbacka RH, Kaufman HL, Collichio F, et al., J Clin Oncol Sep 1;33(25): /19/
28 Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. Andtbacka RH, Kaufman HL, Collichio F, et al., J Clin Oncol Sep 1;33(25): /19/
29 After 3 Injections..
30 US FDA Approved Stage IIIb,c M1a,b,c Systemic Therapy Options Andtbacka RH, Kaufman HL, Collichio F, et al., J Clin Oncol Sep 1;33(25): /19/
31 Outline 2015 Therapeutic options: Stage IV patients» Systemic» Surgical Therapeutic options: Stage III patients» Systemic» Surgical Sentinel Node Update 5/19/
32 (MSLT-I) Compares Immediate vs. Delayed CLND for Nodal Metastases Melanoma mm SN(-) WEX + SNB 60% Observation Randomized SN(+) Immediate CLND WEX + Watch & Wait Observ. 40% Nodal Recurrence Delayed CLND Melanoma-specific Survival p=ns Morton, NEJM 2006
33 (MSLT-I) Compares Immediate vs. Delayed CLND for Nodal Metastases Melanoma mm 5 year Melanoma Survival: SN(-) WEX + SNB 60% Observation Randomized SN(+) Immediate CLND WEX + Watch & Wait Observ. 40% Nodal Recurrence Delayed CLND Mean # Nodes % 72.3% 52.4% HR 2.48; p<0.001 HR 0.51; p<0.001 Morton, NEJM 2006
34 Morton, NEJM 2006 To come Patients with T2/T3 melanomas and nodal metastases derive a 20% absolute survival advantage with a SN procedure and CLND as compared to watchful waiting CAVEAT: DSMB advised release of data to physicians and public because multiple endpoints had been reached, but not overall survival
35 No survival advantage 1/2008 Standard of care for patients with T2 or T3 melanoma 24% False-positivity 1/2008
36 Demonstrating Biology Metastatic melanoma cells, regardless of the size of the cluster, have biologic relevance Ollila et al., JACS 2009 Society of Surgical Oncology Position Statement Annals of Surgical Oncology 2012
37 Recurrence and Death events for each tumor burden group (n=578) Tumor Burden Node negative N (% ) Recurrence n(%) Distance Recurrence n(%) Death n(%) 488 (84%) 56 (11%) 35 (7%) 52 (11%) <0.1mm 33 (6%) 8 (24%) 5 (15%) 5 (15%) mm 27 (5%) 10 (37%) 6 (22%) 6 (22%) >1.0mm 30 (5%) 21 (70%) 14 (47%) 12 (40%) Ollila et al., JACS 2009
38 (MSLT-I) Compares Immediate vs. Delayed CLND for Nodal Metastases Melanoma mm SN(-) WEX + SNB 60% Observation Randomized SN(+) Immediate CLND WEX + Watch & Wait Observ. 40% Nodal Recurrence Delayed CLND Melanoma-specific Survival p=ns Morton, NEJM 2014
39 (MSLT-I) Compares Immediate vs. Delayed CLND for Nodal Metastases Melanoma mm 10 year Melanoma Survival: SN(-) WEX + SNB 60% Observation Randomized SN(+) Immediate CLND WEX + Watch & Wait Observ. 40% Nodal Recurrence Delayed CLND Mean # Nodes % 62.1% 33.5% HR 3.09; p<0.001 HR 0.51; p<0.001 Morton, NEJM 2014
40 Recommendations for Stage III SN+ Patients Patients with any disease, including submicroscopic (<0.1mm) deposits of metastatic melanoma have biologically relevant, potentially life-threatening disease. CLND is recommended unless enrolled on a clinical trial Systemic adjuvant therapy options: observation, ipilimumab or clinical trial
41 Recommendations for Palpable Stage III Patients Staging with PET/CT CLND is recommended unless enrolled on a clinical trial Systemic adjuvant therapy options: observation, TVEC, ipilimumab or clinical trial
42 UNC Dermatology & Skin Cancer Center Thank you NC Cancer Hospital 42
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