Zelboraf: A Major Focal Point at CHI’s 2nd Annual Oncology Clinical Trials Conference

Nov. 10, 2011 - PRLog -- Cambridge Healthtech Institute today announces three case studies to be presented on Roche’s Zelboraf  (vismodegib ), a drug treating melanoma, the deadliest form of skin cancer, at the Second Annual Oncology Clinical Trials: Bringing Targeted & Tailored Cancer Therapy to Patient conference to be held on March 21-23, 2012 at the Moscone North Convention Center in San Francisco, CA. The FDA approved Zelboraf two months ahead of schedule.

“This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug,” as mentioned in an FDA news release dated August 17, 2011.

Case studies to be discussed CHI’s conference:

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.

Zelboraf/Cobas Lessons Learned: Prospective Co-development of a Companion Diagnostic in Cancer Medicine
Jeffrey Lawrence, M.D., Director, Oncology, 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.

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.

Early registration discounts are available until November 18, 2011. To view the entire conference agenda and to register, please visit http://www.TriConference.com/cct.

To inquire about sponsoring and/or exhibiting, contact Jon Stroup, 781-972-5483, jstroup@healthtech.com.

Writers and editors are encouraged to attend. To request a press pass, contact Tracey Fielding at tfielding@healthtech.com.

About Cambridge Healthtech Institute (www.chicorporate.com)

Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Barnett International, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.

Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.

Contact:
James Prudhomme
Cambridge Healthtech Institute
781-972-5400
jprudhomme@healthtech.com