On May 29, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported additional positive efficacy and favorable safety data were featured in a virtual oral poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference (Press release, Cardiff Oncology, MAY 29, 2020, View Source [SID1234558760]).

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The new data from Cardiff Oncology’s ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) continues to demonstrate that primary efficacy endpoint of overall objective response (ORR), as measured by tumor regression, is ten-fold greater than current standard-of-care of 4%. To-date, 89% of evaluable patients in the onvansertib trial have achieved a clinical response and the response appears durable with patients having progression-free survival (PFS) of at least 6 months. Onvansertib has also shown its effectiveness in targeting the most prevalent KRAS mutation subtypes associated with colorectal cancer, which until recently have been considered to be undruggable.

"We are pleased to be participating in this clinical trial and importantly, our patients are not only tolerating the combination of onvansertib plus standard-of-care FOLFIRI and bevacizumab, but we are very encouraged by the efficacy we are seeing," said Dr. Daniel Ahn, lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona. "Being able to effectively treat patients with KRAS-mutated mCRC has been a challenge and their prognosis is poor. Onvansertib is showing great potential as a new second-line treatment option, in combination with standard-of-care, for these patients."

"Our trial is achieving critical milestones and gaining momentum," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "We continue to see safety and efficacy demonstrated and this, coupled with the FDA granting of Fast Track Designation, is further validation of the potential value of onvansertib to tackle the once undruggable KRAS-mutations that drive aggressive growth of CRC tumors."

Highlights of the ASCO (Free ASCO Whitepaper) Presentation – Onvansertib in KRAS-Mutated mCRC Phase 1b/2 Trial

In the Phase 1b dose escalation, the 1st two dose levels (onvansertib 12 mg/m2 and 15 mg/m2) have been cleared for safety; the 3rd dose level (onvansertib 18 mg/m2) is enrolling; the maximum tolerated dose has not been reached to-date
As of the data cutoff date, clinical response was observed in 8 (89%) of the 9 evaluable patients and post the data cutoff 1 additional patient achieved an objective response:
As of the ASCO (Free ASCO Whitepaper) cutoff date, 4 patients had experienced an objective response, and another 4 patients had stable disease
One patient proceeded to have successful curative surgery; an unprecedented event in this patient population
Progression-free survival (PFS) is >6 months, with 6 patients remaining on treatment
Decreases in plasma KRAS mutation level during the first cycle of treatment are highly predictive of tumor regression and subsequent therapeutic response:
Onvansertib effectively targets all prevalent KRAS mutation subtypes associated with CRC
8 of the 9 patients had a KRAS mutation detected by ctDNA analysis at baseline (ddPCR and NGS)
Changes in KRAS mutant during cycle 1 of treatment were highly predictive of tumor regression:
5 patients had a decrease in KRAS mutant to non-detectable level in cycle 1 (28 days) and subsequent tumor regression at 8 weeks
The Phase 2 continuation trial will further assess the safety and efficacy of onvansertib at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI + bevacizumab, as well as the value of KRAS liquid biopsy to predict treatment response
About the Phase 1b/2 Clinical Trial of Onvansertib in KRAS-Mutated mCRC

The ongoing trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation (NCT03829410) is evaluating the safety and efficacy of onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab). Up to 44 patients, with a confirmed KRAS mutation, metastatic and unresectable disease, who have failed or are intolerant of treatment with FOLFOX (fluoropyrimidine and oxaliplatin) with or without Avastin (bevacizumab), will be enrolled. The trial is being conducted at two prestigious cancer centers: USC Norris Comprehensive Cancer Center and the Mayo Clinic Cancer Center.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Cardiff Oncology believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).

Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On May 29, 2020 Eisai reported updated results from ENHANCE 1, a Phase 1b/2 study exploring the investigational combination of eribulin plus pembrolizumab in patients with metastatic triple-negative breast cancer (mTNBC) from a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program from May 29-31 (Abstract# 1015 / Poster# 100) (Press release, Eisai, MAY 29, 2020, View Source [SID1234558759]).

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Eisai logo. (PRNewsFoto/Eisai Inc.) (PRNewsfoto/Eisai Inc.)
Eisai logo. (PRNewsFoto/Eisai Inc.) (PRNewsfoto/Eisai Inc.)
This open-label, single-arm, multicenter, Phase 1b/2 study enrolled patients with mTNBC who had previously received zero to two systemic therapies for metastatic disease and were stratified by prior number of therapy (Stratum 1 = 0 prior therapies; Stratum 2 = 1-2 prior therapies). As there were no dose-limiting toxicities observed in Phase 1, patients received the recommended Phase 2 dose of eribulin (1.4 mg/m2 intravenously on Day 1 and Day 8) and pembrolizumab (200 mg intravenously on Day 1) of a 21-day cycle. At the time of data cutoff (July 31, 2019), 167 patients were enrolled (of which 149 patients had confirmed PD-L1 status). The primary objectives were safety and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent imaging review. Secondary objectives included progression free survival (PFS), overall survival (OS), duration of response (DOR) and clinical benefit rate (CBR) overall and by PD-L1 status. Previous findings from ENHANCE 1 were presented during a Spotlight Session at the San Antonio Breast Cancer Symposium (SABCS) in 2017.

Updated findings presented during ASCO (Free ASCO Whitepaper)20 showed:

In the study, no dose-limiting toxicities were observed. Safety information is consistent with previous reports.
Of the total patients enrolled (N=167), the combination of eribulin plus pembrolizumab resulted in an overall ORR of 23.4% (95% CI: 17.2-30.5), the primary efficacy endpoint of the study. The ORR in Stratum 1 (n=66) was 25.8% (95% CI: 15.8-38.0), and the ORR in Stratum 2 (n=101) was 21.8% (95% CI: 14.2-31.1). The overall median PFS was 4.1 months (95% CI: 3.5-4.2 months), and the overall median OS was 16.1 months (95% CI: 13.3-18.5 months), which were secondary endpoints of the study.
In Stratum 1 of patients with confirmed PD-L1 status who received the combination of eribulin plus pembrolizumab in the first line (n=60):
ORR was 34.5% (95% CI: 17.9-54.3) in patients with PD-L1+ tumors (n=29) and 16.1% (95% CI: 5.5-33.7) in patients with PD-L1- tumors (n=31)
The median PFS was 6.1 months (95% CI: 4.1-10.2 months) for patients with PD-L1+ tumors and 3.5 months (95% CI: 2.0-4.2 months) for patients with PD-L1- tumors
The median OS was 21 months (95% CI: 8.3-29.0 months) for patients with PD-L1+ tumors and 15.2 months (95% CI: 12.8-19.4 months) for patients with PD-L1- tumors
The median DOR was 8.3 months (95% CI: 3.2 months-NE) for patients with PD-L1+ tumors and 15.2 months (95% CI: 6.5-22.2 months) for patients with PD-L1- tumors
In Stratum 2 of patients with confirmed PD-L1 status who received the combination of eribulin plus pembrolizumab in the second line or later (n=89):
ORR was 24.4% (95% CI: 12.9-39.5) in patients with PD-L1+ tumors (n=45) and 18.2% (95% CI: 8.2-32.7) in patients with PD-L1- tumors (n=44)
The median PFS was 4.1 months (95% CI: 2.1-4.8 months) for patients with PD-L1+ tumors and 3.9 months (95% CI: 2.3-6.3 months) for patients with PD-L1- tumors
The median OS was 14 months (95% CI: 11.0-19.4 months) in patients with PD-L1+ tumors and 15.5 months (95% CI: 12.4-18.7 months) in patients with PD-L1- tumors
The median DOR was 8.2 months (95% CI: 5.1-25.1 months) for patients with PD-L1+ tumors and 8.6 months (95% CI: 3.5-13.2 months) for patients with PD-L1- tumors
The most common treatment-emergent adverse events were fatigue (66%), nausea (57%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). No deaths were considered treatment related. The most common possibly immune-related TEAEs for pembrolizumab (occurring in >3% of patients) were hypothyroidism (18%), pneumonitis (11%), hyperthyroidism (8%) and infusion-related reaction (3%).

"Treatment options for metastatic triple-negative breast cancer remain limited, despite advances in the field," said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "As a human health care company, we are committed to addressing cancers that remain difficult to treat, and this is evident in our ongoing investigation in triple-negative disease. As long as unmet needs exist, Eisai will persist in our efforts to innovate for patients."

This release discusses an investigational use for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Previously, data from ENHANCE 1 was reported at the San Antonio Breast Cancer Symposium in 2016 and 2017.

The study is being conducted under an existing clinical trial collaboration agreement between Eisai and Merck.

About HALAVEN (eribulin mesylate) Injection
HALAVEN (eribulin mesylate) injection is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.

Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN, click here for the full Prescribing Information.

HALAVEN is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

On May 29, 2020 Amphivena Therapeutics, a clinical-stage immuno-oncology company focused on developing immunotherapeutics that restore anti-cancer immunity to the patient, reported data from a Phase 1 study of its lead clinical candidate AMV564 in a poster presentation at the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Amphivena Therapeutics, MAY 29, 2020, View Source [SID1234558758]).

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The Phase 1 dose escalation study (NCT04128423) has enrolled 18 advanced solid tumor patients at the time of data cut off. AMV564 was administered once daily via subcutaneous injection, either alone or in combination with pembrolizumab for 2 weeks out of every 3-week cycle.

AMV564 was well tolerated with no dose-limiting toxicities reported in monotherapy or combination therapy cohorts. Assessment of the pharmacodynamic effects of AMV564 using patient blood samples at various timepoints demonstrated depletion of myeloid derived suppressor cells (MDSC) and increases in CD8:Treg ratio with AMV564 treatment.

AMV564 demonstrated single-agent activity including one complete response in a patient with heavily pre-treated (including prior checkpoint inhibitor therapy) ovarian cancer, who remains on study after 10 cycles of treatment. The disease control rates for the monotherapy and combination arms were 45 percent and 29 percent, respectively.

Details of the Presentation:

Title: A Phase 1 Study to Evaluate the T-cell Engager AMV564 Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Authors: Starodub, A. et al.
Abstract Number: 3101 (Poster: 165)

The full abstract and poster will be available on ASCO (Free ASCO Whitepaper) conference and Amphivena websites as of 8:00AM ET on Friday, May 29th.

About AMV564

AMV564 relieves immune suppression via targeted depletion of MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 80 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).

On May 29, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it has completed the secondary offering of 13,014,646 shares of its common stock held by Sanofi, which includes the exercise in full of the underwriters’ option to purchase additional shares from Sanofi, at a public offering price of $515.00 per share (Press release, Regeneron, MAY 29, 2020, View Source [SID1234558757]). The Company also announced the completion of its repurchase of 9,806,805 shares directly from Sanofi at a price of $509.85 per share (representing the price paid by the underwriters in the offering), for an aggregate purchase amount of $5 billion. Pursuant to the offering and repurchase, Sanofi has disposed of all of its shares of common stock in Regeneron, other than 400,000 shares that it is retaining.

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Regeneron did not receive any of the proceeds from the sale of shares of its common stock by Sanofi. The public offering occurred simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs & Co. LLC, together with Barclays, BNP Paribas, Citigroup, J.P. Morgan, Morgan Stanley as joint book-running managers.

Regeneron has filed a registration statement (including a prospectus) with the SEC for the offering. Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed and will file with the SEC, including the final prospectus supplement dated May 26, 2020, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement, if you request them by contacting BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected]; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected].

On May 29, 2020 Sumitovant Biopharma Ltd. announced that Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, and one of five healthcare companies in the Sumitovant family of companies, reported that additional results from its Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer presented orally at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and simultaneously published in the New England Journal of Medicine (NEJM) (Press release, Sumitovant Biopharma, MAY 29, 2020, View Source [SID1234558755]). The data expand on earlier findings from the HERO study, demonstrating the superiority of relugolix to leuprolide acetate across multiple endpoints, and further show that treatment with relugolix was associated with a lower risk of major adverse cardiovascular events compared to leuprolide acetate.

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Relugolix met the primary endpoint and demonstrated superiority to leuprolide acetate across six key secondary endpoints, all with p-values < 0.0001. In the primary endpoint responder analysis, 96.7% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks, compared to 88.8% of men treated with leuprolide acetate.

Detailed secondary endpoint data, presented and published today, showed notable differences in the rapid and profound suppression of testosterone, PSA response, and testosterone recovery after discontinuation of treatment. In the relugolix group, testosterone suppression to less than 50 ng/dL was achieved in 56.0% of men by Day 4 and 98.7% by Day 15, compared to 0.0% by Day 4 and 12.1% by Day 15 for men in the leuprolide acetate group. Additionally, in the relugolix group, profound testosterone suppression to less than 20 ng/dL was achieved in 78.4% of men at Day 15, compared to 1.0% at Day 15 for men in the leuprolide acetate group. A higher proportion of men in the relugolix group achieved a 50% reduction in PSA by Day 15 and confirmed at Day 29 compared to those in the leuprolide acetate group (79.4% vs. 19.8%, respectively). Within 90 days of treatment discontinuation, 54% of men in the relugolix group achieved normal testosterone levels (≥ 280 ng/dL) with a mean testosterone level of 288.4 ng/dL, compared to 3% of men in the leuprolide acetate group with a mean testosterone level of 58.6 ng/dL.

"A faster effect in lowering testosterone for prostate cancer patients can be clinically significant – likewise, a more rapid testosterone recovery after stopping treatment, could potentially improve a patient’s quality of life," said Neal Shore, M.D., medical director of the Carolina Urologic Research Center, HERO program steering committee member, presenter of the ASCO (Free ASCO Whitepaper) data, and lead author on the NEJM paper. "Both of these findings could make a meaningful difference in the treatment journey for men with advanced prostate cancer."

Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events compared to men in the leuprolide acetate group (2.9% vs. 6.2%, respectively). Additionally, in men with a history of these events, the relugolix group had 80% fewer major adverse cardiovascular events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). More than 90% of men in the HERO study had at least one cardiovascular risk factor, including lifestyle risk factors such as tobacco use and obesity, comorbidities such as diabetes and hypertension, and prior history of a major adverse cardiovascular event.

"Cardiovascular disease is the leading cause of death in men with prostate cancer," said Dr. Shore. "An oral therapeutic option with strong efficacy that also reduces cardiovascular risk compared to that of conventional GnRH agonist therapy would be a critical achievement for men with advanced prostate cancer."

As previously reported, the incidence of adverse events in the HERO study was comparable for relugolix and leuprolide acetate groups (92.9% vs. 93.5%, respectively). The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, mild to moderate diarrhea, and arthralgia.

"Relugolix has the potential to be an important new treatment option for men with prostate cancer and would represent significant progress in our company’s commitment to redefine care for men," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "We are grateful to have the opportunity to share these additional data through presentation and publication in such highly-respected venues as the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the New England Journal of Medicine. We have already submitted our New Drug Application to the FDA with the goal of bringing this oral, once-daily potential treatment to men with prostate cancer as expeditiously as possible, especially given the current environment with the COVID-19 pandemic and the difficulties and risks men face traveling to hospitals and clinics to receive injections."

Myovant submitted a New Drug Application (NDA) to the FDA for relugolix in April 2020, which, if approved, would be the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist treatment for men with advanced prostate cancer.

The ASCO (Free ASCO Whitepaper) presentation (#5602), "HERO phase III trial: Results comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer," is available for on-demand viewing.

Conference Call
Myovant will hold a conference call to discuss these data on Monday, June 1, 2020 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. Myovant management will be joined by Neal Shore, M.D. To participate in the live conference call, please dial 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.

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 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men enrolled in the study 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.

Data from an additional key secondary endpoint, castration resistance-free survival, are expected in the third quarter of 2020.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Treatment for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, or slow-release injections are the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial rise in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 200,000 men are treated with androgen deprivation therapy with a GnRH agonist or antagonist each year.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing relugolix as a monotherapy tablet (120 mg once daily) for men with advanced prostate cancer. Myovant is also developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis.