On March 3, 2014 Heat Biologics reported that the first patient has been dosed in its Phase 1/2 bladder cancer clinical study with product candidate, HS-410 (Press release Heat Biologics, MAR 3, 2014, View Source [SID:1234500207]). HS-410 is an investigational biologic designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer. Dosing for the HS-410 Phase 1/2 study was initiated by clinical investigator Lawrence Karsh, M.D., F.A.C.S., at The Urology Center of Colorado in Denver.
The multi-center Phase 1/2 study will enroll approximately 93 patients and is designed to determine whether vaccination with HS-410 after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo. The trial will also test the safety of HS-410 in bladder cancer patients.

On March 3, 2014 Dendreon Corporation reported results for the fourth quarter and full year ended December 31, 2013. Net product revenue for the year ended December 31, 2013 was $283.7 million compared to $325.3 million for the year ended December 31, 2012 (Press release Dendreon, MAR 3, 2014, View Source [SID:1234500204]). Net product revenue for the fourth quarter ended December 31, 2013 was $74.8 million compared to $81.6 million on a pro-forma basis for the fourth quarter ended December 31, 2012, which excludes a $3.8 million favorable adjustment to the Company’s chargebacks reserve due to a change in estimate.
New commercial model in place to improve execution with Silvio Pacheco as Chief Customer Officer and Bill Jenkinson as Chief Marketing Officer. Dendreon is advancing automation efforts in the U.S. which is key to lower COGS in U.S. and also more efficiently make PROVENGE available worldwide. As a first step, Dendreon will make PROVENGE available in Europe through Centers of Excellence using Contract Manufacturing Organization (PharmaCell), beginning with Germany and the United Kingdom.

On March 3, 2014 Roche announced that an independent data monitoring committee has recommended that the Phase III METLung study be stopped due to a lack of clinically meaningful efficacy (Press release Hoffmann-La Roche, MAR 3, 2014, View Source [SID:1234500215]).
The study evaluated if onartuzumab (MetMab) in combination with Tarceva (erlotinib) helped patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors were identified as MET-positive live longer compared to Tarceva alone. Overall adverse event rates were generally similar between the two groups. Data will be submitted for presentation at a forthcoming medical meeting.
Roche is evaluating the implications of the METLung study results across the ongoing onartuzumab clinical programme.