Myovant Sciences Announces Results of Additional Secondary Endpoint of Castration Resistance-Free Survival from Phase 3 HERO Study of Relugolix in Advanced Prostate Cancer
GlobeNewswire
Myovant Sciences, Inc.
,GlobeNewswire•September 29, 2020
Relugolix had a similar rate of castration resistance-free survival in the subgroup of men with metastatic disease compared to leuprolide acetate (74% vs. 75%, respectively) and did not achieve statistical superiority (p = 0.84)
Relugolix is under Priority Review with an FDA target action date of December 20, 2020, supported by positive Phase 3 HERO study results including a 97% responder rate and six positive key secondary endpoints
BASEL, Switzerland, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.
“These new data from the Phase 3 HERO study show that three out of four men with metastatic prostate cancer remained castration resistance-free through 48 weeks while on oral relugolix, in-line with leuprolide acetate injections, the current standard of care,” said Dan George, M.D., a professor of medicine and surgery at the Duke University School of Medicine and HERO program steering committee member. “I continue to be excited by relugolix as a potential new and differentiated treatment option for men with prostate cancer given its robust clinical and safety data, including the lower risk of major adverse cardiovascular events compared to leuprolide acetate.”
Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels (< 50 ng/dL). In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% men treated with leuprolide acetate (HR = 1.03 [95% CI: 0.68-1.57]; p = 0.84). In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen (PSA) progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause. PSA progression was defined as a PSA increase ≥ 25% and ≥ 2 ng/mL above the nadir, and confirmed by a second PSA value ≥ 3 weeks later.
“We believe the totality of data – including previously reported data from the Phase 3 HERO program, published in the New England Journal of Medicine – presents compelling evidence for the potential use of relugolix in men with advanced prostate cancer,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences. “With our New Drug Application under Priority Review by the FDA, we look forward to our target action date in December 2020 and hope to advance our commitment to redefining care by bringing once-daily, oral relugolix to men with prostate cancer.”
The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed.
Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. In the Phase 3 HERO study, relugolix met the primary efficacy endpoint, with 96.7% of men treated with relugolix achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks versus 88.8% of men treated with leuprolide acetate. Relugolix also met six key secondary endpoints, demonstrating rapid and profound suppression of testosterone and PSA response, in addition to improved testosterone recovery after discontinuation of treatment. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events (MACE) compared to men in the leuprolide acetate group (2.9% vs. 6.2%, respectively). In men with a reported history of MACE, the relugolix group had 80% fewer MACE events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively).
About the Phase 3 HERO Program in Advanced Prostate Cancer
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.
