Darolutamide plus androgen deprivation therapy and docetaxel significantly increases overall survival in patients with metastatic hormone-sensitive prostate cancer

On February 17, 2022 Orion Biotechnology reported that Results from the Phase III ARASENS trial have shown that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001) (Press release, Orion Biotechnology, FEB 17, 2022, View Source [SID1234608321]). At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months). Darolutamide plus ADT and docetaxel also showed consistent benefits for secondary endpoints and pre-specified subgroups. Adverse event (AE) rates were not increased by the addition of darolutamide. These results were presented at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

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"Metastatic prostate cancer is a uniformly fatal disease and despite progress in recent years, only 30% of these men will survive beyond five years. ARASENS demonstrated that the addition of darolutamide, an androgen receptor inhibitor, significantly increased overall survival for patients receiving standard androgen deprivation therapy and docetaxel as initial treatment for metastatic hormone-sensitive prostate cancer. Darolutamide also improved time to castration-resistant prostate cancer and other key secondary endpoints," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. "These results are an important step forward for the treatment of patients with metastatic hormone-sensitive prostate cancer."

"At Orion, we are excited about the ARASENS trial results showing that darolutamide adds to the benefits of chemotherapy plus ADT for the patients with mHSPC. These results encourage us to further discover and develop new treatments for patients with prostate cancer", said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.

ARASENS is the only randomized, double-blind pivotal study prospectively designed to compare the use of a second-generation ARi plus ADT and docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in mHSPC.

Darolutamide is approved in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa, for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease. The product is developed jointly by Orion and Bayer. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

Detailed results from ARASENS

The significant improvement in OS was observed despite substantially higher use of subsequent systemic antineoplastic therapies (such as abiraterone, enzalutamide, cabazitaxel, docetaxel, radium-223 dichloride, sipuleucel-T, lutetium-177 PSMA, or apalutamide) among patients receiving ADT plus docetaxel who entered follow-up (75.6%) compared with the group who received darolutamide plus ADT and docetaxel (56.8%). The ARASENS data also showed consistent improvements in key secondary endpoints including delaying the time to CRPC compared to the placebo arm (HR=0.36, 95% CI 0.30-0.42; P<0.001). Darolutamide plus ADT and docetaxel also significantly delayed time to pain progression versus ADT plus docetaxel (HR=0.79, 95% CI 0.66-0.95; P=0.01), time to first symptomatic skeletal event (SSE) (HR=0.71, 95% CI 0.54-0.94; P=0.02) and time to initiation of subsequent systemic antineoplastic therapy (HR=0.39, 95% CI 0.33-0.46; P<0.001).

Treatment-emergent adverse events (TEAEs) were similar between treatment arms. The most common TEAEs (≥10%) were highest during the overlapping docetaxel treatment period for both arms and decreased progressively thereafter. The most frequently reported AEs in the treatment arms (darolutamide plus ADT and docetaxel versus ADT plus docetaxel) were alopecia (40.5% and 40.6%, respectively), neutropenia (39.3% and 38.8, respectively), fatigue (33.1% and 32.9%, respectively) and anemia (27.8% and 25.1%, respectively). Grade 3 or 4 AEs reported in 66.1% versus 63.5% of patients were mainly due to neutropenia (33.7% versus 34.2%, respectively), which is a well-known effect of docetaxel treatment. Serious AEs occurred in 44.8% versus 42.3% of patients, and TEAEs leading to treatment discontinuation occurred in 13.5% versus 10.6% of patients.

AEs of special interest in patients treated with AR pathway inhibitors for prostate cancer such as fatigue, falls, fractures, mental impairment, and cardiovascular events were similar between study arms.

About the ARASENS trial

The ARASENS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety of oral darolutamide, an androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite these treatments, most men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited survival.

About darolutamide

Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial. The product is approved under the brand name Nubeqa in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

NexImmune Appoints Kristi Jones as Chief Executive Officer and Member of the Board of Directors

On February 17, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Kristi Jones has been appointed as the Company’s Chief Executive Officer and a member of its Board of Directors (Press release, NexImmune, FEB 17, 2022, View Source [SID1234608320]). Her appointment follows the departure of Scott Carmer, who submitted his letter of resignation this week.

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"The Board is pleased to appoint Kristi Jones as our new Chief Executive Officer and member of the Board of Directors," said Sol J. Barer, Chairman of NexImmune’s Board of Directors. "Kristi’s decades of experience in the biotechnology and pharmaceutical industries, which includes her playing a pivotal role in NexImmune’s strategic vision as Chief Business Officer and, most recently, Chief Operating Officer, make her the ideal candidate to lead the Company going forward. As we begin this transition, we are fortunate to have such a talented, innovative, and experienced leader to take us into the next phase of growth for the Company. We would also like to thank Scott Carmer for his contributions."

"It has been my privilege to be a part of NexImmune’s leadership team for the past six years, and I am honored to take on these new responsibilities," said Kristi Jones, NexImmune’s Chief Executive Officer. "I want to thank the Board of Directors for an extraordinary opportunity, and I look forward to building upon our groundbreaking efforts to unlock the potential of immunotherapies and revolutionize treatments for patients with high unmet medical need."

Prior to her roles as Chief Business Officer and Chief Operating Officer at NexImmune, Ms. Jones spent more than 25 years in various strategic and operational leadership roles at AstraZeneca (and its biologics R&D subsidiary, MedImmune), Genentech and Eli Lilly. At AstraZeneca, she was Vice President of Portfolio Strategy and Management, where she played an instrumental role in building a scientifically innovative, diverse portfolio creating new value for the Company. Prior to that role, she served as Vice President of Global Strategic Marketing to shape product plans and prepare MedImmune for multiple launches. Previously, Ms. Jones held multiple leadership roles with increasing responsibility at Genentech/Roche, where she worked for 16 years, including Head of Immunology and Ophthalmology in Global Portfolio and Product Strategy at Roche, Head of the Endocrine and Pulmonary franchise at Genentech, and Head of Immunology Business Unit Operations and Pipeline Planning at Genentech. Ms. Jones also served in a consulting role for various companies and organizations and serves on the Life Science Panel for Springboard Enterprises focused on start-up companies led by women. She is also an elected member to the Cell Therapy Committee of the Alliance for Regenerative Medicine. Ms. Jones received her RPh from the University of Texas and a BS in Biology from Texas Tech University.

e-Meet VECT-HORUS at the digital BIO Europe Spring from March 28 to 31, 2022

On February 17, 2022 Emmanuelle BETTENDORF reported that it will participate in BioEurope Spring from March 28 to 31, 2022 and will be available to meet with you on partnership opportunities (Press release, Vect-Horus, FEB 17, 2022, View Source [SID1234608261]).

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Sorrento Announces That It Has Acquired a Majority Ownership in Diagnostic Manufacturer Zhengzhou Fortune Bioscience in Response to Increasing Worldwide Demand For COVISTIX™

On February 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the acquisition of a majority ownership of Zhengzhou Fortune Bioscience Co., Ltd. ("FortuneBio") (Press release, Sorrento Therapeutics, FEB 17, 2022, View Source [SID1234608260]). This acquisition is in response to dramatically increasing demands worldwide and planned product build-up in anticipation of potential additional approvals for Sorrento’s COVISTIXTM COVID-19 VIRUS Rapid Antigen Detection Test.

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FortuneBio specializes in the manufacture of lateral flow diagnostic tests with numerous approved products marketed in over 20 countries for pregnancy tests, fecal occult blood test, and drug abuse test kits. FortuneBio has an ISO 13885 facility and is capable of producing tens of millions of lateral flow tests per month. FortuneBio is currently expanding production capabilities to meet COVISTIX demand worldwide.

COVISTIX is a sensitive and rapid antigen diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients. "While most rapid antigen tests are negatively impacted with a reduced LoD sensitivity to the Omicron variant1, in a laboratory setting with live Omicron viruses, COVISTIX demonstrated the ability to detect the Omicron variant at an even lower LoD as compared to that of the original SARS-CoV-2 strain. Our lateral flow antigen test uses a platinum colloid coupled with a pair of specific antibodies to give a clear black line if virus is present, in contrast to many tests which use a gold colloid which results in a pink or red line. This proprietary platinum colloid technology is what contributes to our improved Omicron LoD sensitivity," said Brian Cooley, Sorrento’s SVP for Drug Delivery and Diagnostics.

"COVISTIX demand is increasing rapidly worldwide due to its high sensitivity as compared with other EUA-approved tests. By acquiring a majority stake in FortuneBio, Sorrento is in a better position to rapidly respond to the ever-changing demand of rapid COVID testing and broaden our diagnostic product offering to other areas such as early cancer diagnostics," stated Dr. Henry Ji, Chairman and CEO of Sorrento. "In addition to providing product revenue from an established portfolio of approved diagnostic tests, FortuneBio gives Sorrento an experienced diagnostic research, development and manufacturing team and an ISO-certified facility to rapidly advance and commercialize our antibody-enabled diagnostic products in synergy with our antibody therapeutics."

1SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests

Regeneron Announces Investor Conference Presentations

On February 17, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, FEB 17, 2022, View Source [SID1234608259]):

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Cowen 42nd Annual Health Care Conference at 1:30 p.m. ET on Tuesday, March 8, 2022
Oppenheimer 32nd Annual Healthcare Conference at 10:00 a.m. ET on Tuesday, March 15, 2022
Barclays Global Healthcare Conference at 8:00 a.m. ET on Wednesday, March 16, 2022
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.