Megan Epperson from Kantar closed out our initial day at ASCO 2019 with the first look at interim data from the Phase 3 TITAN trial.
In this study, investigators are evaluating third-generation AR inhibitor ERLEADA vs placebo as first line therapy for metastatic castration-sensitive prostate cancer patients undergoing androgen deprivation therapy.
In the TITAN trial, patients receiving Erleada showed a 52% reduction in the risk of radiographic progression free survival over placebo with a hazard ratio of 0.48. This benefit was also fairly consistent across subgroups, even for those with high disease volume or the roughly 10% of patients who had received prior therapy with docetaxel.
Additionally, patients receiving ERLEADA showed a significant reduction in the risk of death with a 24 month OS rate of 82% vs 74% for placebo. And these benefits came with a manageable safety profile.
Overall the initial data from the TITAN trial shows the addition of erleada to androgen deprivation therapy in metastatic castration sensitive patients provides significant benefit in an all-comer population.
However, while Erleada is likely to see an approval based on this trial, it will need to differentiate itself from additional competitors looking to enter this space, as well as from in-house competitor Zytiga, which may shortly lose patent protection in the US, and is already approved for use in this group of patients.
Looking ahead in this landscape that is focused on increasing treatment intensity for metastatic castration sensitive patients, the hurdle of differentiating between the agents and choosing the right therapy for the right patient remains.