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Oncology Clinical Trials 

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Wednesday, February 22

 

CASE STUDIES OF LED-TO-APPROVAL CLINICAL TRIALS

Xalkori Case Study

7:55 am Chairperson's RemarksKeith Wilner, Ph.D., Senior Director, Oncology Clinical Development, Pfizer, Inc. 

8:00 Integrating Companion Diagnostics into Clinical Drug Development: Crizotinib Case Study

Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide Research & Development, Clinical Research and Precision Medicine, Pfizer, Inc.

Fully integrating a diagnostic test into crizotinib pivotal trials, leading to a simultaneous submission of a drug-diagnostics combination, presented many challenges as well as opportunities in the development of crizotinib for treatment of NSCLC patients.

8:30 Speed of Drug Development by Incorporation of a Companion Test: Crizotinib Case Study

Keith Wilner, Ph.D., Senior Director, Oncology Clinical Development, Pfizer, Inc.

The use of a diagnostic test to appropriately identify a patient population expected to benefit from crizotinib treatment led to smaller clinical trials in NSCLC to meet the primary statistical endpoints as well as a greater chance of successful trials.

9:00 Simultaneous Approval of a Therapeutic & Companion Diagnostic: Crizotinib Case Study

Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.

The simultaneous submission and approval of Pfizer's crizotinib and Abbott Molecular's anaplastic lymphoma kinase (ALK) break-apart FISH companion diagnostic presented unique clinical and regulatory challenges, requiring novel approaches as well as close collaboration between Pfizer, Abbott, CDER, and CDRH.

9:30 Transforming Clinical Development with Adaptive Trials Oncology – A Case Study of an Oncology Registration TrialCyrus Mehta, Ph.D., President and Co-Founder, Cytel Inc.Why are adaptive approaches on the rise in late phase oncology studies? Over 50% of confirmatory studies end in failure - a distressing reality for cancer treatment developers and the medical community. In response, adaptive design strategies are helping reverse thisdiscouraging trend.
 
Using examples of ongoing adaptive trials – including the VALOR trial - a pivotal study to treat Acute Myeloid Leukemia, you'll learn:
 - the adaptations the FDA and EMA allow in both earlier and confirmatory stages
 - harnessing Conditional Power to effectively "de-risk" oncology development
 - to make the most of interim analysis with the validated "Promising Zone" design strategy
 - ethical considerations: what do participating patients gain in an adaptive study?
 
10:00 Transition to Plenary Keynote 

 

Plenary Keynote 

10:10 Plenary Keynote Presentation  

Sponsored by
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11:00 Refreshment Break in the Exhibit Hall with Poster Viewing

Adcetris Case Study 

12:00 pm Clinical Development of Brentuximab Vedotin: Five Remarkable Years from First Patient Treated to Accelerated Approval

Eric Sievers, M.D., Vice President, Clinical Affairs, Seattle Genetics

Observation of multiple complete remissions among advanced lymphoma patients treated in a phase one setting led Seattle Genetics to pursue paired, single-arm, registrational trials. We will review the overall strategy that led to marketing registration in 2011.

12:30 Accelerated Approval of a Targeted Antibody-Drug Conjugate (ADC): Brentuximab Vedotin Case Study

Elaine S. Waller, Pharm.D., M.B.A., Senior Vice President, Regulatory Affairs, Seattle Genetics, Inc.

FDA review of the brentuximab vedotin BLAs was complex due to inclusion of two indications, the ADC technology, and an ODAC environment influenced by recent hearings on accelerated approval of oncology drugs.

1:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

2:00 Ice Cream Refreshment Break in the Exhibit Hall with Poster Viewing

 

Plenary Keynote Panel 

2:30 Plenary Keynote Panel  

3:50 Refreshment Break & Poster Awards in the Exhibit Hall

Zelboraf Case Study

4:25 Chairperson's RemarksElaine S. Waller, Pharm.D., M.B.A., Senior Vice President, Regulatory Affairs, Seattle Genetics, Inc. 

4:30 Zelboraf in Metastatic Melanoma: Interim Analysis Considerations in a Phase III Trial

Chris Bowden, M.D., Vice President, Oncology Clinical Development, Genentech, Inc.

BRIM-3, a randomized Phase III trial in patients with V600+ metastatic melanoma, compared Zelboraf to dacarbazine treatment. The rationale for changing the primary endpoint from overall survival to the co-primary endpoints of overall survival and progression-free survival will be discussed.

5:00 Zelboraf/Cobas Lessons Learned: Prospective
Co-development of a Companion Diagnostic in Cancer Medicine

Lara Hashimoto, Ph.D., Lifecycle Leader, Genomics and Oncology, Vice President, Roche Molecular Systems, Inc.

The cobas 4800 BRAF V600 Mutation Test was the companion diagnostic assay used to screen >2,300 melanoma patients for Phase II and Phase III trials of Zelboraf. Clinical validation of the cobas BRAF test vs. Sanger sequencing will be discussed.

5:30 Zelboraf Regulatory Perspectives: Lessons Learned and Future Implications

Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.

Approval of the BRAF-targeted therapy ZELBORAF with the cobas BRAF diagnostic test exemplifies the process encouraged in FDA's 2011 In Vitro Diagnostic Companion Guidance. Lessons learned highlight considerations for navigating co-development approvals and next steps for CDER/CDRH guidance.

6:00 Panel DISCUSSION: Lessons Learned from Case Studies  
Moderator: Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide Research & Development, Clinical Research and Precision Medicine, Pfizer, Inc.
Panelists:
Keith Wilner, Ph.D., Senior Director, Oncology Clinical Development, Pfizer, Inc.
Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.
Eric Sievers, M.D., Vice President, Clinical Affairs, Seattle Genetics
Elaine S. Waller, Pharm.D., M.B.A., Senior Vice President, Regulatory Affairs, Seattle Genetics, Inc.
Chris Bowden, M.D., Vice President, Oncology Clinical Development, Genentech, Inc.
Lara Hashimoto, Ph.D., Lifecycle Leader, Genomics and Oncology, Vice President, Roche Molecular Systems, Inc.
Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.

 

6:30 Close of Day



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