Honestly, I don't think this is terrible or great news.I am...

Honestly, I don't think this is terrible or great news.

I am concerned about the lack of statistical significance at that alpha level of 0.10. However, this is possibly due to the under-powered study due to the smaller sample size (n=36). I don't agree that the PFS HR is completely comparable to the ToGA study (Bang et al., 2010). Theirs was a large Phase III study (n=584 patients randomised into control/treatment arms) and with a PFS HR p value was statistically significant reporting 0.0003 (compared to Her-Vaxx p value of 0.266).

I would have expected a lower PFS HR for Her-Vaxx given its ability to elicit a polyclonal antibody response compared to Herception's monoclonal antibody response. Again, there's probably a clinical benefit in Her-Vaxx as an adjunct to chemotherapy but the small sample size might be the shortcoming.

I'm not convinced that this PFS result alone shows any competitive and/or clinical advantage over Herceptin but will hold on to see if the overall survival (OS) is statistically significant and is better than the ToGA study's results. They reported an OS of 0.74 with a p value of 0.0046. Time will tell.


References

Bang, Y. J., Van Cutsem, E., Feyereislova, A., Chung, H. C., Shen, L., Sawaki, A., ... & ToGA Trial Investigators. (2010). Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. The Lancet, 376(9742), 687-697.