On December 3, 2021 Bayer reported The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint (Press release, Bayer, DEC 3, 2021, View Source [SID1234596439]). In the ARASENS trial, NUBEQA in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms. Detailed results of the study are planned to be presented at an upcoming scientific congress. NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

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The ARASENS trial investigating NUBEQA is the only Phase III randomized, multi-center, double-blind trial, which was prospectively designed to evaluate the efficacy and safety of a combination of an ARi with docetaxel and ADT compared to docetaxel and ADT in patients with mHSPC.1

"For patients with mHSPC, there remains a significant need for new therapeutic approaches that improve treatment outcomes. ARASENS was prospectively designed to investigate whether combining NUBEQA with docetaxel and ADT could lead to an increase in overall survival for men with mHSPC," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. "We are especially grateful to the patients and investigators for participating in this important trial and look forward to presenting the full results at an upcoming meeting."

Bayer plans to discuss the data from ARASENS with health authorities worldwide regarding the submission of NUBEQA for marketing authorization in this indication.

About the ARASENS Trial1

The ARASENS trial (NCT02799602) is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial, which was prospectively designed to investigate the safety and efficacy of oral NUBEQA, an androgen receptor inhibitor (ARi), in combination with the chemotherapy docetaxel and androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, in addition to docetaxel and standard ADT.

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

About the ARANOTE Trial

The ARANOTE trial (NCT04736199) is a randomized, double-blind, placebo-controlled Phase III study of NUBEQA in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint of this study is radiological progression-free survival (rPFS), as measured as the time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.

About NUBEQA (darolutamide)2

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.2

On July 30, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or androgen deprivation therapy (ADT) alone. The primary efficacy endpoint was metastasis-free survival (MFS). NUBEQA is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in metastatic hormone-sensitive prostate cancer (mHSPC) (ARANOTE) as well as a Phase III trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP). Information about these trials can be found at www.clinicaltrials.gov.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is currently indicated for the treatment of men with nmCRPC.2 The approvals of NUBEQA in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.2 Filings in other regions are underway or planned.

INDICATION FOR NUBEQA (darolutamide)

NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION FOR NUBEQA (darolutamide)

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

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.3

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.4,5 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. Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.6,7

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On December 3, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has closed its acquisition of Toxikon Corporation, a contract research organization delivering best-in-class nonclinical testing services (Press release, LabCorp, DEC 3, 2021, View Source [SID1234596440]). The addition of Toxikon to Labcorp Drug Development bolsters Labcorp’s strong nonclinical development portfolio, and creates a strategic footprint for the company to partner with pharmaceutical and biotechnology clients in the Boston, Mass., area.

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The definitive agreement for the transaction was announced on Nov. 18. Specific terms were not disclosed.

On December 3, 2021 Henlius Biotech (Fosun) reported that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA) (Press release, Shanghai Henlius Biotech, DEC 3, 2021, View Source [SID1234605560]). It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Hanbeitai is the company’s fourth monoclonal antibody (mAb) approved in China, following rituximab biosimilar Hanlikang, trastuzumab biosimilar Hanquyou (ZercepacⓇ in the EU), and adalimumab biosimilar Handayuan. The pipeline has been further replenished with widened indication coverage including hematological malignancies, solid tumors, auto-immune diseases, etc.

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Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "We are excited to have Hanbeitai get approved as our fourth product. The credit goes to all the healthcare professionals, patients and regulatory authorities that have contributed to the studies of Hanbeitai. While maximizing the value of biosimilar drugs, we will continue advancing the clinical trial process of its combination with in-house immunotherapy products, such as serplulimab, and growing into a more innovative global biopharmaceutical company."

Mr. Jason Zhu, President of Henlius, said, "Lung cancer and colorectal cancer are ranked second and third with high incidence of cancers in the world, respectively. They are also ranked first and second in China, and there is a huge demand for treatment. The similarity studies showed no statistically significant difference in efficacy, and the safety are highly similar to the originator. It is believed that the approval of Hanbeitai will further improve the accessibility of bevacizumab and provide a high-quality option for patients with lung cancer and colorectal cancer."

Study showed Hanbeitai is highly similar to the originator, addressing significant unmet clinical needs

Hanbeitai was developed in accordance with the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative), and has received support from National Science and Technology Major Project in the 12th & 13th Five-Year Plans of China-Major New Drug Research & Development Project. The approval is mainly supported by a series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies, comparative clinical studies. Different from approved bevacizumab biosimilars in China, the Phase 3 study of Hanbeitai was conducted among Chinese patients with metastatic colorectal cancer (CRC), which helps to accumulate more clinical evidence and experience of bevacizumab in this patient population. The relevant Phase 3 clinical studies were published at the 23rd annual conference of Chinese Society of Clinical Oncology (CSCO) for the first time and awarded an "outstanding study paper". And then the Phase 3 results were published on the world-renowned journal BioDrugs. The Phase 1 clinical study results were also published on Cancer Chemotherapy and Pharmacology.

According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally and accounts for 11.4% of the global cancer incidence in 2020. It is estimated that 810,000 people are diagnosed with LC in China, and LC is the first leading cause of cancer incidence and mortality. NSCLC is the most common type of LC, accounting for 80%-85%. The incidence rate of CRC ranks second among all malignant tumours in China, with over 550,000 new cases in 2020. Clinical studies showed that adding bevacizumab to traditional chemotherapies can significantly delay disease progression and prolong survival for patients with mCRC and is one of the standards of care for advanced CRC.

By specific binding with vascular endothelial growth factor (VEGF), Hanbeitai can block the interaction between VEGF and its receptors. This will inhibit tumour angiogenesis, which is essential for the growth and metastases of tumour. The originator has been approved for CRC, LC, glioblastoma, hepatocellular carcinoma (HCC), ovarian cancer, cervical cancer in China. For global the indications also include renal cell carcinoma and breast cancer, and so on. However, there are still significant unmet needs due to drug accessibility in China. Going beyond, Henlius will explore more indications to benefit more patients.

Exploring more therapies

Building upon the advantages in the field of broad-spectrum anti-tumour of bevacizumab, Henlius is actively developing combo therapies of Hanbeitai and its anti-PD-1 mAb serplulimab for the treatment of various solid tumours. Clinical studies of this combo have been conducted in first-line nsNSCLC and first-line CRC. The first-line nsNSCLC study has entered the pivotal Phase 3 stage. The CRC Phase 2 clinical trial is on track. With the continuous exploration, Henlius aims to benefit patients with immuno-oncology mAbs combination therapies as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC.

According to the requirements of ophthalmic drugs, Henlius is also developing a new ophthalmic preparation product, HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection), based on Hanbeitai, through optimizing the prescription, specifications and production processes of Hanbeitai, with active ingredients remaining unchanged. It is intended to be used for the treatment of wet age-related macular degeneration (wAMD). In the first half of 2021, HLX04-O has been approved to carry out Phase 3 clinical trials in Australia, the United States, Singapore, and EU countries such as Latvia, Hungary and Spain. In addition, the first patient was dosed in a HLX04-O Phase 3 clinical trial in China for the treatment of wAMD.

Looking forward, with its core values of "Affordable Innovation, Reliable Quality", Henlius is actively accelerating the R&D and commercialisation of more biologics and enriching innovative target layouts. What’s more, the company will continue developing a forward-looking presence in bispecific antibodies and antibody-drug conjugates (ADC), and bringing more high-quality and affordable therapies to patients worldwide.

On December 3, 2021 AstraZeneca reported that it will underscore its ambition to redefine care with new data from across its portfolio of innovative medicines at the 2021 San Antonio Breast Cancer Symposium (SABCS) 7-10 December 2021 (Press release, AstraZeneca, DEC 3, 2021, View Source [SID1234596424]).

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Fourteen AstraZeneca medicines and potential new medicines from the pipeline will be featured across 33 abstracts showcasing the Company’s leadership across different types and stages of breast cancer, including three oral presentations.

Breast cancer is now the most diagnosed cancer worldwide with an estimated 2.3 million people diagnosed in 2020.1

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Continuing our year of breakthroughs in breast cancer, our data at SABCS will reinforce the practice-changing potential of Enhertu with new analyses from the DESTINY-Breast03 trial. Early data from the BEGONIA and TROPION-PanTumor01 trials demonstrate great promise in treating patients who have limited treatment options. These data build on our decades of experience in pioneering medicines to redefine care for patients."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Progress in breast cancer increasingly involves more personalised approaches to treating patients across subtypes and stages of disease, which is a key focus of our data at this year’s SABCS. Our extensive knowledge of breast cancer disease biology and the patient experience fuel our ambition to deliver medicines that can truly revolutionise and reshape treatment for every type of breast cancer patient."

Transforming the treatment of advanced breast cancers with antibody drug conjugates (ADCs)
An oral presentation will share further results from a range of patient subgroups from the DESTINY-Breast03 Phase III trial, including those with stable brain metastases and patients characterised by hormone receptor status, number of prior lines of therapy or status of visceral metastasis.

Results from DESTINY-Breast03 demonstrated superior progression-free survival (PFS) for Enhertu (trastuzumab deruxtecan) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer previously treated with trastuzumab and a taxane.

In another oral presentation, updated results from the TROPION-PanTumor01 Phase I trial will continue to build promising evidence of the anti-tumour activity of datopotamab deruxtecan in patients with triple-negative breast cancer (TNBC).

Treating breast cancer early where there is more opportunity for cure
New data on patient quality of life from the OlympiA Phase III trial of Lynparza (olaparib) will be presented as an oral presentation.

These patient-reported outcomes data will provide compelling evidence that further supports Lynparza as a potential treatment option for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk HER2-negative early breast cancer.

The supplemental New Drug Application of Lynparza for this indication was recently granted Priority Review by the US Food and Drug Administration.

Changing the treatment landscape with next-generation medicines and novel combinations
A poster and spotlight poster discussion will share results from the BEGONIA Phase Ib/II trial testing Imfinzi (durvalumab) combinations in advanced/metastatic TNBC with data from arm 1 (Imfinzi plus paclitaxel), arm 2 (Imfinzi, paclitaxel and capivasertib) and arm 5 (Imfinzi, paclitaxel and oleclumab), which will further demonstrate the benefits of combining immune checkpoint inhibitors with other novel molecules.

Additionally, ongoing trials posters will share information about the ongoing SERENA-4 Phase III trial which evaluates our next-generation oral selective oestrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with CDK4/6 inhibitors in the 1st-line treatment of patients with oestrogen receptor (ER)-positive, HER2-negative advanced breast cancer, and the SERENA-6 Phase III trial of camizestrant with CDK4/6 inhibitors in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer with an ESR1 mutation.

A further ongoing trial poster will share information on the CAPItello-292 Phase III trial, evaluating the benefit of adding capivasertib (an AKT inhibitor) to the treatment regimen of Faslodex (fulvestrant) and palbociclib in patients with HR-positive, HER2-negative locally advanced, unresectable or metastatic breast cancer.

Enhertu and datopotamab deruxtecan are developed and commercialised in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada).

Key AstraZeneca presentations during SABCS 2021

Lead author

Abstract title

Presentation details

Enhertu (trastuzumab deruxtecan)

Hurvitz S

Trastuzumab deruxtecan (T-DXd; DS-8201a) vs. trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer (mBC): results of the randomized phase 3 study DESTINY-Breast03

Presentation GS3-01

Oral – General Session 3

9 December, 2021

08:45 – 11:30 CT

14:45 – 17:30 GMT

Vaz Batista M

Trastuzumab deruxtecan in patients with HER2[+] or HER2-low–expressing advanced breast cancer and central nervous system involvement: Preliminary results from the DEBBRAH phase 2 study [IIS]

Publication PD4-06

Spotlight Poster Discussion 4

8 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Datopotamab deruxtecan (Dato-DXd)

Krop I

Datopotamab deruxtecan (Dato-DXd) in Advanced/Metastatic Human Epidermal Growth Factor Receptor 2 Negative (HER2−) Breast Cancer: Results From the Phase 1 TROPION-PanTumor01 Study [J101 TNBC prelim results]

Presentation GS1-05

Oral presentation – General Session 1

7 December, 2021

08:00 – 10:45 CT

14:00 – 16:45 GMT

Lynparza (olaparib)

Ganz PA

Quality of life results from OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)-adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER-2 negative early breast cancer

Presentation GS4-09

Oral – General Session 4

10 December, 2021

08:45 – 11:15 CT

14:45 – 17:15 GMT

Imfinzi (durvalumab)

Schmid P

BEGONIA: Phase 1b/2 study of durvalumab (d) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC): Results from arm 1 d + paclitaxel (p), arm 2 d + p + capivasertib (c), and arm 5 d + p + oleclumab (o)

Publication PD10-03

Spotlight Poster Discussion 10

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Camizestrant (AZD9833)

André F

SERENA-4: A Phase III comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive/HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease

Publication OT2-11-06

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Bidard FC

SERENA-6: A Phase III study to assess the efficacy and safety of AZD9833 (camizestrant) compared with aromatase inhibitors when given in combination with palbociclib or abemaciclib in patients with HR+/HER2- metastatic breast cancer with detectable ESR1m who have not experienced disease progression on first-line therapy

Publication OT2-11-05

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Faslodex (fulvestrant) and capivasertib

Rugo HS

CAPItello-292: A phase Ib/III study of capivasertib, palbociclib and fulvestrant, versus placebo, palbociclib and fulvestrant, for endocrine therapy-resistant HR+/HER2− advanced breast cancer

Publication OT2-14-01

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Notes

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex and Zoladex and the next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On December 3, 2021 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.94 per share dividend for the first quarter of 2022 (Press release, Amgen, DEC 3, 2021, View Source [SID1234596441]). The dividend will be paid on March 8, 2022, to all stockholders of record as of the close of business on February 15, 2022. This represents a 10% increase from that paid in each of the previous four quarters.

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