Melanoma. Tawnya L. Bowles, MD Surgical Oncologist, Medical Director for Melanoma Services; Intermountain Medical Center

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1 Melanoma Tawnya L. Bowles, MD Surgical Oncologist, Medical Director for Melanoma Services; Intermountain Medical Center Ken Grossmann, MD, PhD Assistant Professor, Department of Medicine, Oncology Division; Huntsman Cancer Institute, University of Utah Objectives: Identify new immunotherapy treatment options for advanced melanoma Identify clinical trial option available to melanoma patients Discuss how genomics and tumor tissue are being used to advance the care of melanoma patients

2 Melanoma Program Update Intermountain Medical Center Huntsman-Intermountain Cancer Care Program August 25, 2016 Tawnya Bowles, MD, FACS Surgical Oncology

3 Utahns are at high risk for melanoma

4 Utah Melanoma Program How can we best combine efforts to tackle this cancer together--bringing together the best from each institution for our patients?

5 Intermountain Melanoma Clinical Trials Review Name Description Stage Notes Polynoma/MAVIS Vaccine Study SWOG 1404 (Dr. Grossmann PI) Amgen MASTERKEY Phase III randomized placebo-controlled trial of a polyvalent melanoma vaccine Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK (Pembrolizumab) in Patients with High-Risk Resected Melanoma Pembrolizumab With or Without Talimogene Laherparepvec or Talimogene Laherparepvec Placebo in Unresected Melanoma IIB/C, III III, IV Unres ectabl e III,IV Ongoing Ongoing Ongoing Biovex extension study (Amgen) An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEXGM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05 III,IV Ongoing

6 Recently closed trials Name Description Stage Notes DERMA (GSK; CLOSED to accrual) Vical (CLOSED to accrual) MSLT-II (John Wayne Cancer Inst.) BioVex Oncolytic Virus (AMGEN) ECOG 1609 (Eastern Cooperative Oncology Group) Phase III trial of RecMAGE-A3 + AS15 ASCI vs. placebo for MAGE-A3 positive resected Stage IIIB/C melanoma Phase III trial of Allovectin-7 immunotherapeutic for metastatic melanoma Randomized trial of US of lymph node basin vs. completion lymphadenectomy in pts with positive SLN biopsy Randomized Phase III trial of OncoVEX GM-CSF vs. GM-CSF alone in unresectable Stage IIIB/C and Stage IV melanoma Phase III randomized trial comparing ipilimumab and interferon for Stage IIIB/C IIIB/C Study did not show benefit IV Study did not show benefit (390 pts) III IIIB/C and IV IIIB/C 2 nd highest accrual in the world; results pending Extension trial open Accrued well

7 Melanoma Clinical Database Database developed in parallel with HCI to allow for collaboration on clinical projects Received grant funding from Intermountain Research Foundation for chart abstraction Goal of 750 charts abstracted for grant project; we are at ~800 charts of invasive melanoma completely abstracted Concurrent goal of developing prospective database

8 Multidisciplinary melanoma treatment planning conference Held bimonthly in collaboration with Huntsman Cancer Institute Videoconferencing allows participation at IMC and HCI (Utah Cancer Specialist participation at IMC site) Offers opportunity for up to date clinical trial eligibility discussion for patients

9 Outreach efforts Free skin cancer screenings at both institutions (separately run) AIM at melanoma Patient Forum (Dr. Grossmann, HCI) Melanoma Research Foundation, Miles for Melanoma 5K (second annual on Sept. 10) Education through media (radio, TV, Twitter)

10 Clinical projects Quality improvement projects for melanoma Unique opportunity for Intermountain to contribute to joint efforts Genentech grant for a prevention project for melanoma Recent published collaborative projects Ray A, Williams MA, Meek SM, Bowen RC, Grossmann KF, Andtbacka RH, Bowles TL, Hyngstrom JR, Leachman SA, Grossman D, Bowen GM, Holmen SL, VanBrocklin MW, Suneja G, Khong HT. A phase I study of intratumoral ipilimumab and interleukin-2 in patients with advanced melanoma. Oncotarget Jul 6 Terakedis BE, Anker CJ, Leachman SA, Andtbacka RH, Bowen GM, Sause WT, Grossmann KF, Bowles TL, Noyes RD, Hitchcock YJ, Boucher KM, Shrieve DC. Patterns of failure and predictors of outcome in cutaneous malignant melanoma of the scalp. J Am Acad Dermatol Mar;70(3): Andtbacka RH, Donaldson MR, Bowles TL, Bowen GM, Grossmann K, Khong H, Grossman D, Anker C, Florell SR, Bowen A, Duffy KL, Leachman SA, Noyes RD. Sentinel lymph node biopsy for melanoma in pregnant women. Ann Surg Oncol Feb;20(2): Ongoing clinical project of surgical treatment/sentinel lymph node biopsy for melanoma of the external ear (joint database project)

11 Challenges Information technology/privacy challenges in doing joint clinical database projects Running joint clinical trials that are sponsored by pharma Joining together as Utah Melanoma Program in research efforts, including prevention Molecular profiling of tumors sharing data/tissue and advancing clinical trials and treatment options from this