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The Changing Direction of Cancer Care. Patricia Mucci LoRusso, D.O. Director Phase I Clinical Trials Program Karmanos Cancer Institute Detroit, MI. Cancer Statistics. Approximately 3400 people are diagnosed each day of cancer in the United States Approximately 142 cases in Michigan each day

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The changing direction of cancer care l.jpg

The Changing Direction of Cancer Care

Patricia Mucci LoRusso, D.O.

Director Phase I Clinical Trials Program

Karmanos Cancer Institute

Detroit, MI


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Cancer Statistics

Approximately 3400 people are diagnosed each day of cancer in the United States

  • Approximately 142 cases in Michigan each day

    Approximately 1500 people die each day of cancer in the United States

    - Approximately 55 cases in Michigan each day


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Hanahan D, Weinberg RA. Cell. 2000;100:57-70.


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FDA's Critical Path: Innovation or Stagnation?

--Challenge and Opportunity on the Critical Path to New Medical Products, FDA, March 2004


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Challenge

  • Over 860 new drugs currently in clinical development for Oncology

  • Over 43% of all NDAs to the FDA are Oncology Products

  • Resources are limited:

    • Patients, Time & Finances

      • Numbers are monumental

      • Clinical “scientific” answers

  • The task before us is to maximize resource utilization and minimize hardship to patients while expediting delivery of better therapies to the patient



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Goal

It is imperative to understand cancer biology to develop more effective treatments while sparing the patient unnecessary toxicity

Paradigm shift in clinical drug development

Personalizing treatment, which means using our scientific knowledge to help identify which patient will have the greatest treatment benefit with the least amount of toxicity, is crucial for the FUTURE of Cancer Care


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What is Personalized Medicine?

  • Testing patients before prescribing a therapy to best predict response

  • Allows clinicians to prescribe treatments that are safer & more effective

    • For the right disease

    • To the right patient

    • The right therapeutic agent the first time

    • At the right dose and schedule

  • It may involve profiling a patient’s genetics


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“Safe Responders”

Poor Responders

Side Effects

What is Personalized Medicine?

In a general population, there will be patients who are poor responders or who suffer drug side effects


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“Safe Responders”

Poor Responders

Adverse events

What is Personalized Medicine?

Personalized Medicine selects those patients prior to treatment that will be most likely to respond and have the least side effects


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Physicians Need More AccurateClinical Predictors

For Example: Early Stage Breast Cancer

  • For women diagnosed with node negative, ER+ breast cancer

  • ~83% will survive 12 years with surgery and hormonal therapy alone

  • But >90% will be classified as high risk

    • Most will be recommended for chemotherapy

Only 4 % will benefit from chemotherapy


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Patients Need Individualized Treatment Information

  • Will my cancer spread?

  • Do I need chemotherapy after surgery for my cancer type?

  • Are there any new drugs targeted for my type of cancer?


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Cancer Healthcare Consumers are a Rapidly Emerging Force in Personalized Medicine

Problem: funding tissue acquisition for biomarker evaluation


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Can WE Do This? Personalized MedicineIs it Possible?

The Oncology Community is Ready

Clinical Practice MUST catch up to the Science!!


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Melanoma Personalized Medicine

  • 68,720 estimated new cases in the U.S. annually

  • 8,650 estimated deaths in the U.S. annually

  • For advanced disease, objective response rate to standard therapy is approximately 5-20% and only lasts 3-6 months


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??? Personalized Medicine

?????


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PLX4032 Personalized MedicineNovel, small molecule inhibitor

Selected patient population

Unselected patient population


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Lung Cancer Personalized Medicine

  • 219,440 estimated new cases in the U.S. annually

  • 159,390 estimated deaths in the U.S. annually

  • For advanced disease, objective response rate to standard therapy is approximately 24-30%


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PF-02341066 Personalized Medicine

An oral inhibitor of MET and ALK gene targets in tumors

This gene target is selective for a sub-population of patients with lung cancer


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Overall Response Rate = Personalized Medicine65%

Typical Response Rate = <10%

Disease Control Rate = 84%

Clinical Activity of PF-02341066 in Lung Cancer with the ALK Gene Target


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How can we expedite the development and implementation of Personalized Medicine?

What are some of the barriers currently identified?


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Lack of Participation in Studies Personalized Medicine?

Encourage recruitment to clinical trials for the right reasons

Cultural change – clinical practice; academic collaboration


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Michigan Panel on Medical Personalized Medicine?

Education and Research, 2007

  • “Lack of collaboration” recognized as the fundamental weakness of the region’s health care sector

  • Major barrier to the region’s growth of medical education and research

  • Too many regional health care institutions are taking actions that reflect their own self-interest rather than optimizing investments that would maximize service to the community


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“…Michigan's medical, research, and educational institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."

--Richard E. Blouse, Jr., president and CEO of the Detroit Regional Chamber


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Governor Granholm - October 15, 2007 institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."

“Southeast Michigan represents an untapped life sciences economic development bonanza for the entire state of Michigan. When we all collaborate to leverage the region's considerable life sciences assets, our shared vision will make Southeast Michigan a world-class development zone for biosciences, biotechnologies, the health care industry, and pharmaceutical manufacturing."


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Lack of collaboration… institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."

Limits economic development as the region’s assets are diluted and not fully leveraged, leading to unnecessary duplication of services and increasing costs among health care organizations.


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Major Oncology Research Centers institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."

A Collaborative Research Network

will attract:

Patients

Business

Talent


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Research Collaboration is Critical in the institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."Age of Personalized Medicine

  • Share Resources to Create Research Synergies

  • The Best Science from Collaborative Effort

  • Patient Access Expanded to Increase Enrollment

  • The Best Trial for the Particular Patient

  • Most Promising Agents Studied in the State of Michigan

  • The Best Therapies Developed for the Patient


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Thank You!!! institutions play a critical role in restructuring our state's life sciences economy, but we also know that they cannot accomplish their work alone - cooperation among all of the players in the health care industry and units of government in the region are vital to our long-term, collective success."