On March 22, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the fourth quarter and full year 2023 (Press release, Hookipa Pharma, MAR 22, 2024, View Source [SID1234641382]).

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"It was a defining year for HOOKIPA as we witnessed the powerful potential of our novel arenaviral immunotherapies in action. Our HB-200 program delivered potentially best-in-class T cell activation and clinical activity, as this program, in combination with pembrolizumab, showed doubled objective response rate compared to historical standard of care treatment alone," said Joern Aldag, Chief Executive Officer of HOOKIPA. "Our progress last year has positioned us to execute in a meaningful way in 2024. Our data enable us to potentially bring a drug to patients who need new treatment options. We are excited for what is ahead for HOOKIPA, and we look forward to sharing more very soon."

Business Highlights and Recent Developments

Oncology

HB-200 in combination with pembrolizumab: positive preliminary Phase 2 data in patients with recurrent/metastatic HPV16+ head and neck cancers in the first line setting. Data was initially presented in May 2023 and additional patient data was provided in October at the European Society for Medical Oncology Congress 2023.
Data from the ongoing study (NCT04180215), showed a 42 percent objective response rate for 19 evaluable checkpoint inhibitor (CPI)-naïve patients treated with HB-200 in combination with pembrolizumab. These data represent a doubling of the historical response rate (19 percent) reported for pembrolizumab alone.
HOOKIPA is preparing to start a randomized Phase 2/3 trial of HB-200 in combination with pembrolizumab in the 1st-line setting for patients with recurrent/metastatic HPV16+ head and neck cancers.

HOOKIPA’s HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers.
On January 25, 2024, the Company received notification from Roche of their decision to terminate the collaboration and licensing agreement for HOOKIPA’s HB-700 program. To date, HOOKIPA has met all go-forward criteria under the agreement and remains eligible for a final milestone payment associated with IND submission. HB-700 is on-track to an expected IND application filing by April 2024.
Effective April 25, 2024, HOOKIPA will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for this program.

HOOKIPA enrolled the dose escalation cohorts in the Phase 1/2 study of HB-300 (NCT05553639) for the treatment of advanced prostate cancer.
The Study Safety Committee deemed that HB-300 was generally safe and well-tolerated in both dose escalation cohorts.
Initial analysis of target antigen-specific T cell responses—using direct ELISPOT without pre-expansion of T cells—in ten patients between dose level 1 (N=5) and dose level 2 (N=5) indicated a 15- to 26-fold increase of target antigen specific T cells in 30 percent of patients (3/10).
In line with its previously announced strategy to prioritize the development of HB-200, the Company has terminated the Phase 1/2 study of HB-300 and will utilize the associated capital and resources for the advancement of its HB-200 program. HOOKIPA will keep the IND open to allow the potential for further development of this program in the future.
HOOKIPA will publish the final data at a scientific conference, once complete.
Infectious Disease

In August, The Journal of Infectious Disease, published peer-reviewed preclinical data on HB-400, an investigational therapeutic vaccine for chronic hepatitis B (HBV). The data show that HB-400 induced robust, HBV-specific T cell and antibody responses in non-human primates and cleared detectable serum HBV antigens in a mouse model for chronic HBV infection, with near elimination of detectable HBV antigen positive hepatocytes in the liver.
HB-400 (NCT05770895) is currently being evaluated in a Phase 1 trial and is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. Gilead is solely responsible for further development and commercialization of the HBV product candidate.
In November, HOOKIPA’s HB-500 program, an investigational therapeutic vaccine for the treatment of human immunodeficiency virus (HIV), also partnered with Gilead, received FDA clearance of its IND application.
Also in November, Nature Partner Journals Vaccines, published peer-reviewed preclinical data for the program. Data show that HB-500 was well tolerated and generated robust, high-quality and durable immune responses (antigen-specific T cells and antibodies) in non-human primates; and the arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.
HOOKIPA expects to initiate a Phase 1 clinical study of HB-500 in people with HIV in the second quarter of 2024. Under the collaboration agreement with Gilead, HOOKIPA is eligible for a milestone payment upon dosing the first patient in this study.
Corporate and Financial Updates

Corporate Highlights

The Company added two new Board Members in 2023: Malte Peters, M.D., in January and Terry Coelho in April.
Mark Winderlich, Ph.D., will join the Company on April 1, 2024, as Chief Development Officer to lead HOOKIPA’s clinical research and development organization.
On January 29, 2024, HOOKIPA provided an update on its business priorities and oncology partnership programs. The Company announced that it will focus its resources in two strategic areas: (1) prioritize the clinical development of a randomized trial for its HB-200 program and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and human immunodeficiency virus. As part of its strategic refocus, HOOKIPA will pause development activities related to HB-300 and most of its preclinical research activities. The Company also announced that it will regain full control of the intellectual property portfolio and will have full collaboration and licensing rights to the HB-700 program for KRAS-mutated cancers from Roche effective April 25, 2024.
Financial Highlights

In January 2023, HOOKIPA achieved a $5.0 million milestone payment under its HB-400 collaboration agreement with Gilead. The success-based milestone payment reflected the Company’s completion and delivery of a regulatory support package for Gilead’s Phase 1 clinical trial.
In February 2023, HOOKIPA achieved a $10.0 million milestone payment under its HB-700 collaboration agreement with Roche. The success-based milestone payment reflected the start of the HB-700 manufacturing process to support a Phase 1 clinical trial.
In June 2023, the Company completed a $50.0 million public offering of common stock and non-voting convertible preferred stock. The financing was completed in parallel with the initial Phase 2 data release for HB-200.
In December 2023, the Company issued 15 million shares of common stock for approximately $21.25 million, at a price of $1.4167 per share, to Gilead under an amended stock purchase agreement between the companies. HOOKIPA has the right, subject to certain terms and conditions, to sell an additional approximately $8.75 million of common stock to Gilead as pro-rata participation in potential future equity raises.
Anticipated Catalysts & Milestones

Program Indication Upcoming Anticipated Catalysts
Oncology Programs
HB-200 HPV16+ HNSCC
Additional Phase 2 first-line data for HB-200 in combination with pembrolizumab (2Q 2024)
Announcement of pivotal trial design post FDA-feedback (2Q 2024)
Pivotal study start 2024
HB-700 KRAS
IND submission, milestone payment (April 2024)
Publication of preclinical data (2Q 2024)

Infectious Disease Programs: Gilead-Partnered
HB-400 HBV
Gilead-led: Phase 1b actively enrolling
Next milestone: Initiation of Phase 2 (timing determined by Gilead)
HB-500 HIV
Initiation of Phase 1 trial; first patient dosed and associated milestone payment (2Q 2024)

Fourth Quarter and Full Year 2023 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of December 31, 2023 was $117.5 million compared to $113.4 million as of December 31, 2022. The increase was primarily attributable to funds resulting from the follow-on financing in June 2023 and the Gilead stock purchase in December 2023, partly offset by cash used in operating activities.

Revenue: Revenue was $7.4 million and $20.1 million for the three and twelve months ended December 31, 2023, respectively, compared to $7.8 million and $14.2 million for the same periods in 2022. The increase for the twelve months ended December 31, 2023 was primarily due to higher partial recognition of the upfront and milestone payments under the Gilead and Roche collaborations and cost reimbursements for activities related to the preparation of a first human trial under the Roche collaboration, partially offset by lower cost reimbursements received under the Restated Gilead collaboration agreement. The decrease for the three months ended December 31, 2023 was primarily due to a $5.0 million research milestone that was recognized upon achievement related to the Gilead collaboration agreement, partially offset by higher partial recognition of the upfront and milestone payments under the Gilead and Roche collaborations.

Research and Development Expenses: HOOKIPA’s research and development expenses were $21.2 million and $86.4 million for the three and twelve months ended December 31, 2023, respectively, compared to $17.6 million and $68.6 million for the same periods in 2022. The primary drivers of the increase in research and development expenses were higher clinical study expenses for the HB-200 program and increased spending for the HB-700 program.

General and Administrative Expenses: General and administrative expenses amounted to $4.4 million and $18.6 million for the three and twelve months ended December 31, 2023, respectively, compared to $3.8 million and $18.8 million for the same periods in 2022.

Impairment Expenses: Impairment expenses amounted to $12.8 million for the three and twelve months ended December 31, 2023, respectively, and resulted from asset write-offs related to the Company’s GMP manufacturing facility project, that was discontinued as part of the Company’s strategic refocus and rebalance of its cost structure.

Net Loss: HOOKIPA’s net loss was $24.8 million and $81.6 million for the three and twelve months ended December 31, 2023, respectively, compared to $12.3 million and $64.9 million for the same periods in 2022. This increase was primarily due to an increase in research and development expenses and the impairment of the GMP manufacturing facility project.

On March 22, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value (Filing, 8-K, Gilead Sciences, MAR 22, 2024, View Source [SID1234641381]). The addition of CymaBay’s investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio and aligns with its long-standing commitment to bringing transformational medicines to patients.

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"The acquisition of CymaBay brings us a potential best in disease therapy that could transform the treatment landscape for people with primary biliary cholangitis," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "I want to thank the CymaBay team for their efforts and commitment to addressing this high unmet need. We look forward to advancing seladelpar and building on Gilead’s more than 20-year legacy of treating and curing liver disease on a global scale."

On February 12, 2024, Gilead and CymaBay announced that CymaBay, Gilead and Pacific Merger Sub, Inc., a wholly owned subsidiary of Gilead ("Purchaser"), had signed a definitive merger agreement pursuant to which a tender offer would be made. Pursuant to the merger agreement, Gilead and Purchaser commenced a tender offer on February 23, 2024, to acquire all outstanding shares of CymaBay at a price of $32.50 per share. On March 22, 2024, Gilead successfully completed the tender offer for all outstanding shares of common stock of CymaBay and accepted for payment all shares validly tendered and not withdrawn as of the expiration time of the tender offer, and Gilead will promptly pay for such shares, which shares represented approximately 77.3% of CymaBay’s outstanding shares (not including 5,095,996 shares delivered through Notices of Guaranteed Delivery, representing approximately 4.2% of the shares outstanding). Pursuant to the terms of the merger agreement, Purchaser merged with and into CymaBay on March 22, 2024. All outstanding shares of common stock of CymaBay, other than (i) shares owned by Gilead, Purchaser or any of Gilead’s direct or indirect wholly owned subsidiaries, (ii) shares owned by CymaBay, (iii) shares irrevocably accepted by Purchaser for purchase pursuant to the tender offer and (iv) shares held by CymaBay stockholders who properly demand appraisal for their shares under Delaware law, were cancelled and converted into the right to receive cash equal to the $32.50 price per share.

As a result of the completion of the merger, CymaBay has become a wholly owned subsidiary of Gilead and the common stock of CymaBay will no longer be listed for trading on the Nasdaq Global Select Market, which is expected to take effect as of the close of market on March 22, 2024.

This transaction is expected to be accounted for as an asset acquisition and reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $3.10 – $3.20. Reflecting acquisition costs, associated operating expenses and lower interest income, we expect this transaction to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $3.35 – $3.45 relative to the full year 2024 guidance shared on February 6, 2024.

Seladelpar is an investigational product that has not been approved for use anywhere globally, and its safety and efficacy have not been established.

On March 22, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the full-year ended December 31, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAR 22, 2024, View Source [SID1234641380]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete response letter ("CRL") we received last December, and are targeting a Biologics License Application ("BLA") resubmission for cosibelimab by mid-year to potentially obtain marketing approval before the end of 2024. Simultaneously, we continue to execute on a select number of key long lead time commercial launch preparation activities to shorten our launch timeline in anticipation of a potential approval. We remain highly confident in the clinical data and safety package in support of cosibelimab. We look forward to providing additional updates in the second quarter."

2023 and Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023 and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint intends to address the feedback in a BLA resubmission to potentially enable marketing approval in 2024.
In December 2023, Checkpoint announced that the U.S. Patent and Trademark Office ("USPTO") issued a new patent (U.S. Patent No. 11,834,505) covering a method of treating various cancers, including cutaneous squamous cell carcinoma ("cSCC"), through the administration of cosibelimab. Checkpoint secured U.S. patent protection for cosibelimab through at least May 2038.
In October 2023, Checkpoint announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab in patients with metastatic cSCC in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma", describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC). Furthermore, responses continue to remain durable over time.
In June 2023, Checkpoint announced that new pharmacokinetic ("PK") modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach Group Europe 2023 Annual Meeting. Results support comparability of the cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens.
Throughout 2023 and in January 2024, Checkpoint completed multiple registered direct offerings priced At-the-Market under Nasdaq rules and concurrent private placements of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $47.6 million. Additionally, in October 2023, Checkpoint announced entry into a definitive agreement for the immediate exercise of warrants for $11.1 million in gross proceeds.
In March 2024, Checkpoint announced the appointment of accomplished life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors.
Financial Results:

Cash Position: As of December 31, 2023, Checkpoint’s cash and cash equivalents totaled $4.9 million, compared to $12.1 million at December 31, 2022, a decrease of $7.2 million. This cash position is not reflective of the registered direct offering that closed in January 2024 for total gross proceeds of approximately $14.0 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2023, were $43.6 million, compared to $49.8 million for the year ended December 31, 2022, a decrease of $6.2 million. Research and development expenses for the year ended December 31, 2023 included $4.6 million of non-cash stock expenses, compared to $2.8 million in non-cash stock expenses for the year ended December 31, 2022.
G&A Expenses: General and administrative expenses for both the years ended December 31, 2023 and December 31, 2022, were $8.7 million. General and administrative expenses for the year ended December 31, 2023 included $2.7 million of non-cash stock expenses, compared to $2.5 million in non-cash stock expenses for the year ended December 31, 2022.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2023, was $51.8 million, or $3.17 per share, compared to a net loss of $62.6 million, or $7.09 per share, for the year ended December 31, 2022.

On March 22, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Asuragen, part of Bio-Techne’s Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR (Press release, Bio-Techne, MAR 22, 2024, View Source [SID1234641379]).

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The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients. The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy. CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer. The QuantideX kit allows for direct reporting on the International Scale and further streamlines the workflow with easy-to-use analysis software. Clinical lab scientists can run up to 49 samples per plate for a scalable solution.

"Bio-Techne is dedicated to quality and compliance, and we applaud this new IVDR for strengthening the safety and performance requirements for diagnostic products," said Matt McManus, President of Bio-Techne’s Diagnostics & Genomics Segment. "We are proud to achieve this new certification and will continue to provide the molecular diagnostic and liquid biopsy solutions that deliver world-class performance, scalability, and reliable results for the laboratory scientists, physicians, and patients who count on us."

On March 22, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (Press release, Astellas, MAR 22, 2024, View Source [SID1234641378]).

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Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas
"Men with nmHSPC with high-risk biochemical recurrence are very likely to experience disease progression. With approximately 9 out of 10 of these men developing metastatic disease, the need for new and effective treatment options is critical. Today’s positive opinion from the Committee is an important step forward for providing an additional treatment option for these patients and complements the existing efficacy and safety data supporting the use of XTANDI across the prostate cancer disease continuum. We look forward to XTANDI being potentially the first and only androgen receptor signaling inhibitor approved for this patient population in the European Union."

The positive CHMP opinion is based on the results from the Phase 3 EMBARK trial, which were presented as a plenary session during the 2023 American Urological Association Annual Meeting and subsequently published in the New England Journal of Medicine.

The positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 European Union (EU) member states as well as Iceland, Liechtenstein and Norway.2

XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as nmHSPC) with BCR at high risk for metastasis in November 2023. Astellas is also discussing the EMBARK data with other regulatory authorities to support additional license applications for XTANDI in this indication in 2024 and beyond.

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2024.

For more information, please see the press release "European Medicines Agency Validates Type II Variation for Astellas’ XTANDI (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence" issued on September 12, 2023.

About EMBARK
The Astellas- and Pfizer-led Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with nonmetastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk BCR at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered to experience high-risk BCR had a prostate-specific antigen doubling time (PSA-DT) ≤ 9 months; serum testosterone ≥ 150 ng/dL (5.2 nmol/L); and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer, or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide (n=355), enzalutamide 160 mg as a single agent (n=355), or placebo plus leuprolide (n=358). Leuprolide 22.5 mg was administered every 12 weeks.

EMBARK met its primary endpoint of metastasis-free survival (MFS) for the XTANDI plus leuprolide arm, demonstrating a statistically significant reduction in the risk of metastasis or death over placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death due to any cause, whichever occurred first.

The study also met a key secondary endpoint, by demonstrating that patients treated with XTANDI (single agent) had a statistically significant reduction in the risk of metastasis or death versus placebo plus leuprolide, meeting its MFS endpoint.

In EMBARK, Grade 3 or higher adverse events (AEs) were reported in 46% of XTANDI plus leuprolide patients, 50% of patients treated with XTANDI (single agent), and 43% of patients receiving placebo plus leuprolide. Permanent discontinuation due to AEs as the primary reason was reported in 21% of XTANDI plus leuprolide patients, 18% in XTANDI (single agent) patients, and 10% in placebo plus leuprolide patients.

For more information on the EMBARK trial (NCT02319837) go to www.clinicaltrials.gov.

About High Risk Biochemical Recurrent Non-Metastatic Hormone Sensitive Prostate Cancer
In non-metastatic hormone (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC), no evidence of the cancer spreading to distant parts of the body (metastases) is detectable with conventional radiological methods (CT/MRI), and the cancer still responds to medical or surgical treatment designed to lower testosterone levels.3,4 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a BCR within 10 years.5 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer.3 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC and high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA-DT ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death.6

About XTANDI (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the United States, European Union and Japan. Over one million patients have been treated with XTANDI globally.7

About XTANDI (enzalutamide) in the E.U.
Enzalutamide is an androgen receptor signaling inhibitor indicated in the E.U. for the treatment of adult men with:

Metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC) in combination with androgen deprivation therapy (ADT).
High-risk non-metastatic castration-resistant prostate cancer (CRPC).
Metastatic CRPC who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated. It is also indicated in adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Important Safety Information
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

Important Safety Information
For Important Safety Information for enzalutamide please see the Package Insert.