Galena Biopharma Inc (NASDAQ:GALE) a biopharmaceutical firm committed to the commercialization and development of oncology and hematology therapeutics released interim safety results from the NeuVax™ Phase 2b trial. It was a combination study with trastuzumab, while the data was released at the ESMO 2016 in Denmark. The clinical study is a randomized, investigator-sponsored, multicenter, 300 patient Phase IIb trial. It is presently registering HER2 2+ and 1+ node positive, and also high-risk lump negative subjects to assess NeuVax together with trastuzumab for preventing breast cancer reappearance.
Galena data showed that this combination of NeuVax and trastuzumab in HER2 low-expressing patients is well-taken and the cardiac impacts of trastuzumab are not influenced by NeuVax addition. Earlier in March, the 150th subject was randomized into the study, leading this pre-specified safety assessment. There were no considerable differences in treatment elements, but a noteworthy deviation in node positivity valued between the groups.
Galena added that the sponsor projects this randomization imbalance to level over the course of the study. Cardiac EF was evaluated at baseline and successively throughout cure. The big part of toxicities were Grade 2 and 1, and there exists no difference among treatment arms. Also, no difference was found in EF over time. During assessment period, there was 1 CG subject who witnessed a grade III cardiac adverse occurrence, however, their EF reverted to baseline after suspension of trastuzumab.
The experts speak
Bijan Nejadnik, the Chief Medical Officer of Galena, said that this pre-planned, interim safety assessment is crucial to this study. It confirms that the combination of trastuzumab and NeuVax is well-tolerated in subjects, and notably that it does not intensify the cardio-toxicity impacts known to be linked with trastuzumab.
There is a rising agreement that combination therapies yield the utmost clinical benefit. This Phase IIb study remains ongoing with registration projected to close by the year end. As a result, the company project to release first interim immunologic and efficacy results after one-year of follow-up, currently anticipated at the close of 2017. The management is thankful to Dr. George Peoples and his expert team who works on this groundbreaking project.