Metastatic Malignant Melanoma: finally some treatments that work?

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1 Metastatic Malignant Melanoma: finally some treatments that work? Karl D. Lewis, MD Associate Professor of Medicine Division of Medical Oncology Cutaneous Oncology Program University of Colorado Denver Objectives Incidence Standard therapies Emerging therapies for metastatic disease 1

2 Ten Leading Cancer Types From Jemal, A. et al. CA Cancer J Clin 2010;60: Copyright 2010 American Cancer Society Annual Age-Adjusted Cancer Incidence Rates* for Selected Cancers by Sex, United States, 1975 to 2006 From Jemal, A. et al. CA Cancer J Clin 2010;60: Copyright 2010 American Cancer Society 2

3 Melanoma Incidence - American Cancer Society United States, 2010: Greater than 68,000 new cases Accounts for ~4% of skin cancer cases Approximately 8,700 deaths Accounts for vast majority of skin cancer deaths Melanoma Incidence Since 1960s, increased 3-8% per year in people of European background. Incidence: 1935: 1: : 1:75 Review of SEER data shows increase in all stages from 1988 to 1997, however, largest increase in localized and in situ lesions. 3

4 Melanoma Incidence - con t In the US, women have a slightly higher risk than men before the age of 40 years. By the age of 85 years, the risk in men is 2x that of women. Therefore, the highest rates are seen in: Caucasians Elderly Men Trends in Cancer Incidence: (whites) Melanoma Liver Lung Multiple Myeloma Prostate NHL Thyroid Kidney Testis CNS Bladder Breast All Sites Larynx Pancreas Leukemia Hodgkin's Disease Colorectal Uterus Esophagus Ovary Oral Stomach Cervix % Change SEER Data, , Table I 3 4

5 Trends in Cancer Mortality: (whites) Lung Multiple Myeloma Melanoma NHL CNS Kidney Liver Esophagus Pancreas Leukemia Ovary All Sites Stomach Prostate Breast Larynx Bladder Colorectal Thyroid Oral Uterus Testis Hodgkin's Disease Cervix % Change SEER Data, , Table I 3 Average Years of Life Lost per Malignancy Prostate Colorectal Lung/Bronchus All Cancers NHL Ovary Breast Melanoma Testis Childhood Years Data Source: National Centers for Health Statistics 5

6 Melanoma survival is related to stage of disease 1.0 Proportion Surviving Stage I (n=9175) Stage II (n=5739) Stage III (n=1528) Stage IV (n=1158) Localized to skin Lymph nodes Distant spread Survival, years Balch CM, Buzaid AC, Soong S-J, et al. J Clin Oncol. 2001;19: The Problem Metastatic melanoma is a bad disease Melanoma is the tumor that gives cancer a bad name. George Canellos, Dana-Farber Cancer Institute 6

7 Overall Survival for Metastatic Melanoma N Median mo mo mo % Survival Months From Diagnosis There has been no significant improvement in overall survival for metastatic melanoma in the past 30 years Barth. J Am Coll Surg 1995;181:193. FDA Approved Drugs in Use for Stage IV Melanoma Dacarbazine (DTIC) Response rate: <10% in unselected stage IV melanoma patients No proven impact on survival High-dose IL-2 Response rate: 16% in highly selected stage IV melanoma patients Durable responses: ~5% Objective responses to current therapies occur very infrequently, and mostly in skin, soft tissue and lung metastases October 13,

8 Regression of Primary Vitiligo 8

9 Overview of Tumor Immunology Overview: The Antitumor Immune Response Tumor Step 4: Lymphocytes kill tumor cells Tumor cells Step 1: Antigen processing CTL DC Step 3: Lymphocyte activation T-cell receptor Antigen- MHC DC Step 2: Antigen presentation T cell Lymph node 9

10 Dendritic Cells Are Required for T-Cell Activation Self-MHC Antigen T-cell receptor (TCR) Signal 1 Mature dendritic cell T cell B7 CD28 Signal 2 B7 provides a cri cal cos mulatory signal necessary for T- cell ac va on High-dose IL-2 in Metastatic Melanoma J Clin Oncol 17: , 1999 Analysis of 270 patients entered onto eight clinical trials between 1985 and 1993 IL-2: 600,000 or 720,000 IU/kg IV every 8 hrs for up to 14 doses Second treatment after 6 to 9 days of rest Courses repeated every 6 to 12 weeks in stable or responding patients 10

11 Survival for the whole study population (270 patients) Median survival 11.4 months Atkins, M. B. et al. J Clin Oncol; 17: Copyright American Society of Clinical Oncology Complete response to IL-2 11

12 Conclusions Overall survival for metastatic melanoma remains dismal No proven survival benefit for chemotherapy Immunotherapy valid treatment option Long-term (durable) complete responses in small percentage of patients receiving HD IL-2 CTLA4 Blockade 12

13 CTLA4 Is a Fundamental Regulator of T-Cell Activation CTLA4 is expressed on T cells Expression increases after activation of T cells Binds B7 with ~20-fold greater affinity than does CD28 Down-modulates or down-regulates T-cell activation Melero I, et al. Nat Rev Cancer. 2007;7: Leach DR, et al. Science. 1996;271: CTLA4 Receptors Are Up-Regulated Following T-Cell Activation MHC Antigen TCR Dendritic cell CD28 T cell B7 CTLA4 13

14 CTLA4 Negatively Modulates T-Cell Activation MHC TCR Antigen Dendritic cell CD28 T cell CTLA4 B7 CTLA4 binds B7 with greater affinity than does CD28 and sends an inhibitory signal to the T cell. Rationale for CTLA4 Blockade: Releasing a Brake for T-Cell Activation MHC TCR Antigen Dendritic cell CD28 T cell B7 CTLA4 Antibody to CTLA4 prevents interaction with B7. 14

15 Rationale for CTLA4 Blockade: Releasing a Brake for T-Cell Activation MHC TCR Antigen Dendritic cell B7 CD28 T cell CTLA4 Antibody to CTLA4 prevents interaction with B7 and blocks the inhibitory signal. CTLA-4: The Brake on T-Cell Activation T- cell receptor: An gen/mhc CD28:B7 CTLA- 4:B7 Vaccine? Sarniak et al,

16 Original Article Improved Survival with Ipilimumab in Patients with Metastatic Melanoma F. Stephen Hodi, M.D., Steven J. O'Day, M.D., David F. McDermott, M.D., Robert W. Weber, M.D., Jeffrey A. Sosman, M.D., John B. Haanen, M.D., Rene Gonzalez, M.D., Caroline Robert, M.D., Ph.D., Dirk Schadendorf, M.D., Jessica C. Hassel, M.D., Wallace Akerley, M.D., Alfons J.M. van den Eertwegh, M.D., Ph.D., Jose Lutzky, M.D., Paul Lorigan, M.D., Julia M. Vaubel, M.D., Gerald P. Linette, M.D., Ph.D., David Hogg, M.D., Christian H. Ottensmeier, M.D., Ph.D., Celeste Lebbé, M.D., Christian Peschel, M.D., Ian Quirt, M.D., Joseph I. Clark, M.D., Jedd D. Wolchok, M.D., Ph.D., Jeffrey S. Weber, M.D., Ph.D., Jason Tian, Ph.D., Michael J. Yellin, M.D., Geoffrey M. Nichol, M.B., Ch.B., Axel Hoos, M.D., Ph.D., and Walter J. Urba, M.D., Ph.D. N Engl J Med Volume 363(8): August 19, 2010 MDX Phase III randomized second line study: study design Pre-treated metastatic melanoma (N = 676) R A N D O M I Z E Ipilimumab + gp100 (n = 403) Ipilimumab + placebo (n = 137) gp100 + placebo (n = 136) O Day et al, 2010; Hodi et al,

17 MDX010-20: Study Design Details Patients accrued from September 2004 to July centers in 13 countries Stratified for M stage and prior IL-2 Induction regimen Ipilimumab: 3 mg/kg/wk, q3wks x 4 doses gp100: 1 mg q3wks x 4 doses Reinduction regimen Same as induction, in eligible patients O Day et al, 2010; Hodi et al, Baseline Characteristics of the Patients. 3:1:1 randomization Hodi FS et al. N Engl J Med 2010;363:

18 Baseline Characteristics of the Patients. 3:1:1 randomization All had received previous treatment. Hodi FS et al. N Engl J Med 2010;363: Overall Survival and Progression-free Survival Overall survival: Time from study enrollment until time of death Progression-free survival: Time from study enrollment until time of disease progression Hodi FS et al. N Engl J Med 2010;363:

19 Overall Survival and Progression-free Survival Overall survival: Time from study enrollment unitl time of death Median Survival: gp100: 6.4 months Ipi: 10.1 months Ipi + gp100: 10 months HR 0.66; p=0.003 Progression-free survival: Time from study enrollment until time of disease progression Median time to progression: 3.8 months for all groups Hodi FS et al. N Engl J Med 2010;363: Kaplan-Meier Analysis of Survival Proportion Alive (%) lpi + gp100 (arm A) lpi alone (arm B) gp100 alone (arm C) Comparison H R p Value Arms A vs. C Arms B vs. C Time (years) O Day et al, 2010; Hodi et al,

20 Adverse Events Hodi FS et al. N Engl J Med 2010;363: Adverse Events iraes: 60% - ipi 32% - vaccine Grade 3/4: 10-15% - ipi 3% - vaccine 14 deaths related to drug 7 deaths due to iraes Hodi FS et al. N Engl J Med 2010;363:

21 Molecularly targeted therapies Molecularly targeted therapies Proof of concept from drugs such as imatinib: Approved for treatment of CML 9;22 translocation (BCR/ABL) High rates of response and remission Would this work in melanoma? 21

22 Raf Inhibitors J. Clin. Invest. 115(4): (2005) 22

23 Phase I Efficacy Data BRiM -1 Plexxikon/Roche/Genentech PLX4032/RO /RG7204 VEMURAFENIB 23

24 Antitumor Response in Each of the 32 Patients in the Extension Cohort Flaherty KT et al. N Engl J Med 2010;363: BRIM 1: Survival OS, % Median OS, Months Dose escalation/extension (n=48)* NC WT or subtherapeutic exposure (n=33) 5.13 HR=0.136 (95% Cl, ) P< Time Since First Dose, Months *Interim 8/27/10. These patients are still being followed. NC=no change. Data on file. Genentech, Inc. 24

25 Representative PET Scans Day 1 Day 15 Day 1 Day 15 G Bollag et al. Nature 467: , Sept 2010 Phase I Drug-Related Grade 2 and 3 AEs (>5% Patients) Toxicities were monitored and managed with dose interruption and/or modification No discontinuations for AEs Toxicity at 960 mg BID dose (n=32) Arthralgia 34% cuscc 31% Rash 25% Nausea 16% Fatigue 13% Photosensitivity 16% Palmar-plantar dysesthesia 13% Pruritis 13% Lymphopenia 6% 25

26 BRIM-2 Study Design Metastatic Melanoma Prior Treatment V600E+ (n=132) RG7204 (960 mg BID) Endpoints: Primary: BORR (IRC) Secondary: duration of response, PFS, OS, and safety Screened Population Total Screened (n=344) Total Enrolled (n=132) Screen Failures (n=212) Wild-type BRAF 145 CNS metastases 23 No previous standard Tx 7 PD/deterioration 5 QT C exclusion 5 Abnormal labs 4 No tumor block available 4 ECOG >1 4 Other

27 BRIM-2 Study Status Enrollment between October 2009 and March 2010 Data cut-off date - September 27, 2010 Median follow-up is ~ 7 months ( months) Treated (n=132) n (%) Still On Treatment 50 (38) Discontinued 82 (62) Disease Progression 74 (56) Adverse Event 4 (3) Death 1 (1) Consent Withdrawal 1 (1) Other 2 (2) EFFICACY 54 27

28 Tumor Responses Assessed by IRC BORR 52% by IRC* BORR 55% by investigator assessments (INV) RR, including unconfirmed, 68% (INV) *6 patients were unevaluable RG7204 DAY 1 DAY 15 28

29 PLX4032 Day 1 Day 21 PLX4032 February 2010 May

30 RG7204 Day 1 6 Weeks Before BRIM 2: Survival Survival Rate Vemurafenib (n=132) Number at risk: Duration of Survival, Months Vemurafenib n=132 Alive (ie, censored), n (%) 91 (69) Death, n (%) 41 (31) Median OS, mos (95% CI) NR OS at 6 months was ~80% in phase 2; in phase 1, 6-month OS was ~87% NR=not reached. Sosman J, et al. Presented at: Society of Melanoma Research 7th Melanoma Research Congress; November 5, 2010; Sydney, Australia

31 BRIM-2 Summary & Conclusions Efficacy BORR=52%; median response duration of nearly 7 months Median PFS=6.2 mo Median OS has not been reached Safety Common AEs include skin-related toxicities (including cuscc), arthralgia, fatigue, LFT abnormalities AEs are generally reversible with dose modification or interruption Conclusion BRIM-2 has met its primary endpoint. RG7204 is an effective agent in BRAF mutation-positive melanoma patients. 61 BRIM -3 RG7204 vs Dacarbazine Jan Crossover allowed by DSMB 31

32 Potential Mechanism of Resistance to BRAF Inhibition RAS NRAS BRAF V600E CRAF PLX4032/RG7204 GSK AZD6244 GSK GDC0973/(RG7420) MEK 1/2 ERK 1/2 Cell Proliferation 32

33 The Problem Metastatic melanoma is a bad disease Melanoma is the tumor that gives cancer a bad name. George Canellos, Dana-Farber Cancer Institute The Problem Metastatic melanoma is a bad disease Melanoma is the tumor that gives cancer a bad name. George Canellos, Dana-Farber Cancer Institute 33

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