Plexxikon Announces European Approval of Zelboraf® for the Treatment of Patients with BRAF Mutation-Positive Metastatic Melanoma
Berkeley, CA, February 19, 2012 – Plexxikon Inc., a member of Daiichi Sankyo Group, today announced that the European Commission has approved Zelboraf® (vemurafenib) for the monotherapy treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma. The cobas 4800 BRAF V600 Mutation Test, a companion diagnostic used to identify patients with the BRAF mutation, is CE marked and commercially available in Europe. Zelboraf is designed to selectively inhibit the BRAF mutation that occurs in about half of all cases of melanoma.
BRIM3, a global, randomized, open-label, controlled, multicenter, Phase 3 study, compared Zelboraf to dacarbazine (chemotherapy), in 675 patients with previously untreated BRAFV600E mutation-positive, unresectable (inoperable) or metastatic melanoma. The endpoints for BRIM3 were overall survival (OS) and investigator-assessed progression-free survival (PFS). Other endpoints included confirmed investigator-assessed overall response rate.
- The pre-specified interim analysis of BRIM3 showed the risk of death was reduced by 63 percent for patients who received Zelboraf compared to those who received standard first-line treatment (hazard ratio [HR]=0.37, p<0.0001).
- In a post-hoc analysis of BRIM3 data with a longer follow up compared to previous analyses, including cross-over of patients from the chemotherapy treatment arm to the Zelboraf treatment arm, Zelboraf significantly improved survival by providing a median overall survival of 13.2 months compared to 9.6 months for those who received chemotherapy. Historically, patients with metastatic melanoma have had a median survival of six to 10 months. This analysis showed the risk of death was reduced by 38 percent for patients who received Zelboraf compared to those who received chemotherapy (hazard ratio [HR]=0.62, p<0.0001).
- At 12 months, 55% of patients who received Zelboraf were alive, as compared to 43% of patients who received chemotherapy.
Important Safety Information about Zelboraf (vemurafenib)
This information does not take the place of the patient talking to his or her doctor about their medical condition or their treatment with Zelboraf.
Vemurafenib is a novel, oral small molecule, which was approved by the FDA in August 2011 and is being marketed in the U.S. as Zelboraf for the treatment of patients with BRAFV600E mutation-positive inoperable or metastatic melanoma as detected by an FDA-approved test. Zelboraf also has been approved by the European Commission, and in Switzerland, Israel, Brazil, New Zealand and Canada. Zelboraf is not recommended for use in melanoma patients who lack the BRAFV600 mutation. Plexxikon utilized its structure-guided chemistry platform to discover vemurafenib, and initiated clinical development in 2006. Shortly thereafter, Plexxikon and Roche signed a collaboration agreement to co-develop vemurafenib.
The cobas 4800 BRAF V600 Mutation Test, a DNA-based companion diagnostic used to identify patients whose tumors carry the BRAF mutation, was simultaneously approved in the U.S., and is CE marked and commercially available in Europe. Roche Molecular Diagnostics developed the cobas 4800 BRAF V600 Mutation Test following a 2005 agreement with Plexxikon.
Studies of vemurafenib in combination with other approved and investigational medicines as well as in other tumor types are being conducted. More information about ongoing vemurafenib studies is available at www.clinicaltrials.gov (in the U.S.) or www.clinicaltrialregister.eu or on the Roche Clinical Trials Registry at www.roche-trials.com (in the EU). Genentech can also be contacted by calling the company’s clinical trial call center at 1-888-662-6728 or emailing Genentech@druginfo.com.
About Melanoma and BRAF mutation
Melanoma is the most serious type of skin cancer and is growing at a rate of about five to six percent annually. More than 75,000 people in the U.S. and 160,000 people worldwide are diagnosed with melanoma each year. It is one of the deadliest cancers, with a five-year survival rate of 15 to 20 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.
Plexxikon, a member of Daiichi Sankyo Group, is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s lead drug Zelboraf (vemurafenib/PLX4032) was approved by the FDA in August 2011, and is being co-promoted in the U.S. by Daiichi Sankyo Inc. and Genentech. The company is developing a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in oncology, as well as in several other therapeutic indications. Plexxikon’s Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches.