Formidable Option: Orgovyx

Myovant Sciences ushered in the new year of 2021 the very best way the company knew how: its first drug launch. Receiving FDA approval on Dec. 18, 2020, following priority review, Orgovyx® (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer.

Orgovyx works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, which reduces the amount of testosterone the testicles can make.

“The approval and availability of Orgovyx is a meaningful step as Myovant works to bring about a new standard of care for men with advanced prostate cancer,” Dave Marek, CEO of Myovant Sciences, told Pharm Exec. “Orgovyx was shown to be able to rapidly reduce testosterone levels without an initial hormonal surge. Additionally, the Phase III HERO study showed that when therapy is stopped, more than half of patients in the exploratory subgroup had testosterone levels return to normal over the course of a couple of months. The Orgovyx efficacy and safety profile* offers an option that may fit the needs of patients and physicians, providing control of testosterone, which is important in the treatment of advanced prostate cancer.”

Prior to Orgovyx being available through authorized specialty distributors on Jan. 5, 2021, adult patients with advanced prostate cancer could only receive treatment through injections or small implants under the skin. One such therapy, androgen deprivation, uses drugs to lower levels of the hormones that help prostate cancer cells grow. Now, with the approval of Orgovyx, men with advanced prostate cancer can have the efficacy and safety profile of a GnRH antagonist in a daily one-pill treatment option that potentially reduces the need for clinic visits and injections. “In this way, we believe that Orgovyx has the potential to be a new standard of care in androgen deprivation therapy,” says Marek.

In addition to its first approval, the Swiss company also welcomed 2021 by agreeing to a new partnership with Pfizer, which paid $650 million-plus to co-market Orgovyx. According to Marek, the efficacy and safety data from the Phase III HERO study of Orgovyx in men with advanced prostate cancer, published in the New England Journal of Medicine, generated excitement from several potential partners.

“While we were fully prepared to launch without a collaboration, after thoughtful review, we chose Pfizer as an ideal partner based on their robust capabilities and significant experience in prostate cancer and women’s health,” says Marek. “Pfizer has been an outstanding partner and an important contributor to our early launch success.”

In the randomized, open-label trial, patients received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone by day 29 through the end of treatment. The 622 patients who received Orgovyx had a castration rate of 96.7%. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea.

Looking forward

Following launch, Myovant reported Q4 FY20 Orgovyx product revenue of $3.6 million in its first launch quarter in addition to having greater than 2,000 prescribed patients through April. The momentum from launch has continued to accelerate with net product revenues of $10.5 million for first quarter 2021, which exceeds analyst expectations for a consecutive quarter.

“This performance reflects the consistent positive feedback we’ve received from clinicians on the differentiated clinical profile of Orgovyx,” says Marek. “Despite this early success, we know we have much more road in front of us to enable more patients to have the opportunity to benefit from Orgovyx.”

Immediately following launch, Myovant and Pfizer were targeting healthcare providers while building out payer coverage for Orgovyx. Now, the companies are expanding their engagement to reach out more directly to men with prostate cancer. “We’re pleased with the payers’ recognition of the efficacy, safety, and administration profile of Orgovyx that has contributed to our early coverage success,” says Marek.

As of July 1, 2021, Myovant and Pfizer have achieved commercial (over 60%) and Medicare Part D (over 70%) coverage for Orgovyx. The companies are continuing to engage in negotiations with payers to make 2021 coverage decisions and expect to achieve broad coverage before their original calendar year-end 2021 goal. Marek adds, “We have formed the beginnings of a foundation that we believe can support our long-term vision: to establish Orgovyx as the standard of care for androgen deprivation therapy for men with advanced prostate cancer.”

Even while looking forward to the continued success of Orgovyx, there is still much to be said about the efforts put forward by those who contributed during one of the peaks of the COVID-19 pandemic in late 2020. The initial phase of commercial planning was led by board member Adele Gulfo, and later assumed by newly appointed Chief Commercial Officer Lauren Merendino. Through the relationship of majority shareholder Sumitovant Biopharma, Myovant leveraged the capabilities of Sunovion as its market access partner to expedite contracting and distribution execution. In addition, Pfizer’s team of experienced sales reps was on board just four weeks after launch to further expedite outreach. Marek concludes, “I’m proud of what our team and partners accomplished as they truly exemplified our culture of collaboration where we are all unified and devoted to improving the lives of patients with advanced prostate cancer.”

*For full efficacy and safety information about ORGOVYX, please see the full prescribing information here.

Read the profiles of all 2021 product launch selections here.

Andy Studna is an Assistant Editor for Pharm Exec. He can be reached at astudna@mjhlifesciences.com.