Shots:

• The P-III HERO study involves assessing of Relugolix (360mg loading dose followed by 120mg- qd) vs leuprolide acetate (3mos. depot injection) in men in ratio 2:1 with androgen-sensitive advanced prostate cancer requiring at least 1yr. of continuous androgen deprivation therapy
• The P-III HERO study resulted in meeting its 1EPs & all six key 2EPs i.e- 96.7% patients achieved sustained testosterone suppression to castrate levels & rapid and profound suppression of testosterone @4-15 and 15day- PSA suppression @15day- FSH suppression @24wks.- non-inferior to leuprolide acetate on sustained testosterone suppression @48wks. (96.7% vs 88.8%) respectively
• Relugolix is a GnRH receptor antagonist- acts by reducing testicular testosterone production with its anticipated NDA submission to the US FDA in Q2’20 and future regulatory submissions in Europe and Japan

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