could be tomorrow morning
Precision Medicine; Targeted Therapeutics, Novel Therapeutic Modalities
Recent Developments in the treatment of Melanoma
Adil Daud, MD, Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco School of Medicine
He's the real deal.
Monday, September 16, 2013
The FDA has granted Priority Review designation to dabrafenib (Tafinlar) and trametinib (Mekinist) as a combination treatment for patients with unresectable or metastatic melanoma with a BRAFV600E/K mutation.
According to a statement from the drugs’ manufacturer, GlaxoSmithKline, the FDA has set target dates in early January 2014 to review the trametinib and dabrafenib supplements. The drugs were approved simultaneously as single-agents earlier this year.
Each drug treats melanoma through a different mechanism of action. Dabrafenib is a BRAF inhibitor approved to treat patients who express the BRAFV600E mutation, while trametinib, a MEK 1/2 inhibitor is approved to treat patients with either the BRAFV600E or BRAFV600K mutation. Both drugs act on the RAS kinase pathway, dabrafenib at an earlier point than trametinib. A patient will typically develop resistance to dabrafenib monotherapy after about 5 to 7 months. The addition of trametinib helps overcome the tumor’s resistance mechanism, allowing for a more durable response to treatment
The Priority Review was granted based on the results of a randomized phase I/II study that compared combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAFV600E/K mutation-positive metastatic melanoma.
According to the study that was published in the New England Journal of Medicine, progression-free survival (PFS), response rate, and duration of response favored the combination of dabrafenib and trametinib compared to single-agent dabrafenib for patients with BRAFV600E/K –positive metastatic melanoma.
The phase II study randomized 162 patients with BRAFV600E/K –positive metastatic melanoma to one of three treatment arms: monotherapy with dabrafenib at 150 mg/BID; combination of dabrafenib at 150 mg/BID plus 1 mg of once-daily trametinib; or concurrent full doses of both drugs (dabrafenib at 150 mg/BID; once-daily trametinib at 2 mg). The median PFS for patients who received the full dose combination was 9.4 months, as compared with 5.8 months with dabrafenib monotherapy (hazard ratio for progression or death, 0.39; 95% confidence interval, 0.25 to 0.62; P
Updated Oct 3rd 2013 6:20AM
OncoSec Medical to Present at the 12 th Annual BIO Investor Forum
SAN DIEGO--(BUSINESS WIRE)-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the 12th Annual BIO Investor Forum.
Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.
The presentation will take place on Tuesday, October 8 at 2:30 p.m. PT in the Presidio room at the Palace Hotel in San Francisco, California. The presentation will also be webcast and can be viewed at this link:
A webcast replay will be available one hour after the conclusion of the live event and will expire on January 7, 2014.