Widening the Net: The Role of Combination Therapy in Cancer
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1 Widening the Net: The Role of Combination Therapy in Cancer Heather DiBenedetto, MS RAC Global Head of Clinical Operations Translational Clinical Oncology, Novartis July 15, 2015
2 Topics for Discussion Why is cancer different? What is combination therapy? Study Design Regulatory submission Sponsor considerations What is next? 2 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
3 Cancer Why is Cancer Different? It is far from one disease Luminal A Different mutations Breast Lung Melanoma Luminal B TNBC/Basal Her2 Different mutations Different mutations Different mutations 3 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
4 New Therapy A Patient A Patient B Patient C Patient D 20 0 Pretreatment 2 cycles 4 cycles 6 cycles 4 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
5 Tumor Volume New Therapy A After 10 cycles Time of Relapse Patient A Patient B Patient C Patient D 0 5 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
6 Combination Therapy When drugs with different effects are combined, each drug can be used at its optimal dose, without intolerable side effects. For some cancers, the best approach is a combination of surgery, radiation therapy, and chemotherapy.* *Definition of Combination Drug Therapy-The Merck Manuals 6 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
7 Promise of Combination Oncology Trials Cancer trial of drug combination yields 'spectacular' results The Guardian, June Clinical trial analysis suggests drug combination may be highly effective in recurrent ovarian cancer NIH, June 2014 Combination Effective in Advanced Melanoma; Cost Questions Raised ASCO Daily News, May Study: Combination Therapy Could Revolutionize Cancer Treatment Voice of America, June 2013 Exploring the Pathway: The RAS/RAF/ME K/ERK Pathway in Cancer: Combination Therapies and Overcoming Feedback ASCO Daily News, May DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
8 Is Cancer smarter than us? No problemeasy escape 8 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
9 Escape Mechanisms 2. Escape mechanism used and function restored ABC pathway 1. Drug blocks downstream effect 9 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
10 Combination Therapy A + B After 12 cycles Patient A Patient B Patient C Patient D 0 10 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
11 Combination Therapy in Melanoma Royal Marsden patient Vicky Brown s CT scan before treatment (left) and 12 weeks after initial treatment. Photograph: Royal Marsden 11 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
12 Study Design in Drug Combination Therapy One size does not fit all-small molecule, biologics, immunotherapy Novel agent + Novel agent Novel agent + Standard of Care Novel agent + approved agent in a new indication 12 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
13 Study Design in Drug Combination Therapy What data already exists for the compounds? Dose escalation Both agents vs. anchor agent Information from single agent Overlapping risks= Low starting dose Dosing Single Agent Signal seeking Combination in same study Multiple arms Crossover Randomization 13 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
14 Sponsor Considerations in Combinations More complexity Clinical documents Consistency across program More frequent updates, amendments Risk document Drug/Drug interactions More conmed exclusions More assessments Increased monitoring Drug Supply and comliance Naming conventions System limitations Protocol ICF Patient Information Drug Diary 14 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
15 Patient Considerations in Combinations Making a complex study work on a patient level Informed consent form Sample collection Safety, PK, biomarker Blood, Skin, Tumor, Hair, Urine Drug administration Dose strength, pill color, patient kits Patient Tools Appointment reminders, drug diary, instructions, calendar Assessment schedule Long days, multiple visits to clinic 15 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
16 Looking to the future Genetic tumor profiling for all patients Combinations earlier in treatment More immunotherapy Understanding resistance mechanisms and adaptive responses Quest to CURE cancer and not just slow it 16 DiBenedetto/ Arena Oncology Conference/Day 2/July 2015
17 Heather DiBenedetto The messages in this presentation represent my own opinion and not necessarily that of Novartis
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