The HERO study was designed to test the safety and efficacy of Myovant's lead compound, relugolix, as a hopeful treatment for men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. The trial pitted relugolix against the current standard-of-care treatment leuprolide acetate.
Here are the key takeaways from the study:
- Relugolix met its efficacy endpoint. Specifically, 96.7% of men who received relugolix achieved sustained testosterone suppression to castrate levels.
- All six secondary endpoints were met as well.
- The incidence rate of adverse events was similar for both groups of patients. Those who received relugolix had an adverse event rate of 92.9%, which is similar to the 93.5% observed in the leuprolide acetate group.
- Only 3.5% of men discontinued the study early due to adverse events from relugolix. That was also comparable to the 2.6% of men who discontinued early in the leuprolide acetate group.
Management plans on submitting relugolix for FDA approval in the second quarter of 2020. Regulatory submissions are also being planned in Europe and Japan.
Given the strong clinical results, it's easy to understand why shares of Myovant Sciences are soaring today.
Dr. Lynn Seely, Myovant Sciences' CEO, said in a statement: "With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA. We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer."
This data should go a long way toward convincing investors that relugolix is the real deal. If the current peak sales estimates in the high nine figures prove anywhere near correct, then Myovant's rally could easily continue from here.