ENHERTU® ▼ (TRASTUZUMAB DERUXTECAN) NOW AVAILABLE VIA THE CANCER DRUGS FUND FOR THE TREATMENT OF HER2 POSITIVE METASTATIC BREAST CANCER

On April 20, 2021 Daiichi Sankyo UK, Limited (hereafter, Daiichi Sankyo) and AstraZeneca UK reported the news that the National Institute for Health and Care Excellence (NICE) has recommended Enhertu (trastuzumab deruxtecan) for use within the Cancer Drugs Fund (CDF) as an option for treating HER2 positive unresectable or metastatic breast cancer in adults who have received two or more prior anti-HER2 based therapies (Press release, Daiichi Sankyo, APR 20, 2021, View Source [SID1234578262]).

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In the UK, almost 54,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.1,2,3 The impact of the disease is significant, with breast cancer responsible for approximately 12,000 deaths per year.1 There are an estimated 35,000 people living with metastatic breast cancer in the UK, and in around 5% of women the breast cancer has already spread by the time it is diagnosed.4

"HER2 positive disease impacts one in five women with breast cancer, yet there is still no clear standard of care for patients with HER2 positive disease who have progressed following first-and second-line therapy," said Professor Peter Schmid, Barts Cancer Institute. "The availability of trastuzumab deruxtecan through NHS England’s Cancer Drugs Fund is good news for patients and brings an important new treatment option to those whose disease has continued to progress despite previous treatment."

"This authorisation is a significant step forward for the many thousands of people in England living with HER2 positive metastatic breast cancer," said Jo Taylor, founder of METUP UK, an advocacy group for people living with metastatic breast cancer. "Disease progression in metastatic breast cancer patients is an unmet need beyond second line treatment and new medicines are essential in the challenge to suppress this incurable disease."

This recommendation from NICE is based on the results of the single arm, multicentre, open label, phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan (5.4 mg/kg) in 184 patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2-based therapies. Results from the data cut-off in June 2020 demonstrated a confirmed objective response rate (ORR) of 61.4% (95% CI: 54.0-68.5), including a 6.5% complete response rate and a 54.9% partial response rate. After a median follow-up of 20.5 months, the median duration of response (DoR) was 20.8 months (95% CI: 15.0-NR).5 Trastuzumab deruxtecan showed a generally tolerable safety profile with 34 (18.5%) treatment discontinuations due to treatment-emergent adverse events.6

"We are very proud to have worked with NICE, NHS England and the breast cancer community to make trastuzumab deruxtecan available, through the Cancer Drugs Fund, to eligible patients in England with HER2 positive metastatic breast cancer whose disease has progressed following treatment with two anti-HER2 directed therapies," said Haran Maheson, Commercial Director for Oncology, Daiichi Sankyo U.K.

"Though many treatment advances have been made in HER2 positive metastatic breast cancer, there has been no clear standard of care for patients following progression after second line treatment and many patients do not have a durable response to other available later-line options. To know that patients in England now have access to a new treatment option is welcome news indeed," said Arun Krishna, Head of Oncology, AstraZeneca U.K.

Daiichi Sankyo and AstraZeneca UK will continue working in close partnership with NICE as additional data are collected throughout the managed access period. During this time, eligible patients will be able to access trastuzumab deruxtecan in advance of a decision from NICE on routine funding on the NHS.

The CDF recommendation is applicable to patients in England. Discussions with Welsh and Northern Irish health authorities are ongoing and the submission for the appraisal of trastuzumab deruxtecan to the Scottish Medicines Consortium is currently in development, with a decision expected later in 2021.

The safety of trastuzumab deruxtecan has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2 positive breast cancer who received at least one dose of trastuzumab deruxtecan 5.4 mg/kg in clinical studies. The median duration of exposure to trastuzumab deruxtecan was 9.8 months (range: 0.7 to 37.1 months). The most common adverse reactions were nausea (79.9%), fatigue (60.3%), vomiting (48.7%), alopecia (46.2%), constipation (35.9%), decreased appetite (34.6%), anaemia (33.8%), neutropenia (32.5%), diarrhoea (30.8%), thrombocytopenia (23.1%), cough (21.4%), leukopenia (20.5%), and headache (20.1%).5

Cases of interstitial lung disease (ILD) or pneumonitis were reported in 15% of the 234 patients. Fatal outcomes were observed in 3% of patients. Patients should be advised to immediately report cough, dyspnoea, fever, and/or any new or worsening respiratory symptoms. Patients should be monitored for signs and symptoms of ILD or pneumonitis and those with suspected ILD or pneumonitis should be evaluated by radiographic imaging, preferably a computed tomography (CT) scan. Patients with a history of ILD or pneumonitis may be at increased risk.5

For further information about trastuzumab deruxtecan, such as the licensed indication and safety profile, please refer to the summary of product characteristics.

About HER2 positive breast cancer

HER2 is an epidermal growth factor receptor expressed on the surface of many types of tumours, including breast cancer. HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer.7

There remain significant unmet clinical needs for patients with HER2 positive metastatic breast cancer. The disease remains incurable, with patients eventually progressing after currently available treatment options.8,9

About DESTINY-Breast01

DESTINY-Breast01 was a phase 2, single-arm, open-label, global, multicentre, two-part trial evaluating the safety and efficacy of trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2-based regimens, including trastuzumab emtansine (100%), trastuzumab (100%), and pertuzumab (65.8%). The primary endpoint of the trial was confirmed ORR, as determined by independent central review. Key secondary objectives were disease control rate, clinical-benefit rate, duration of response, progression-free survival, and safety.

About trastuzumab deruxtecan

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Trastuzumab deruxtecan is comprised of a humanised anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.

About the collaboration between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan in March 2019, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of trastuzumab deruxtecan.

Autolus Therapeutics Receives Innovation Passport and entry into ILAP for AUTO4 for the treatment of T cell receptor constant region beta chain 1 (TRBC1) positive T cell lymphomas

On April 20, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO4 being studied in a Phase 1 study in TRBC1 positive Peripheral T Cell Lymphoma (PTCL) (Press release, Autolus, APR 20, 2021, View Source [SID1234578261]).

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"The granting of the Innovation Passport and entry into ILAP comes soon after we received PRIority MEdicines (PRIME) designation from the European Medicines Agency for AUTO1, with both designations accelerating the review of promising therapies targeting unmet medical needs," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "We look forward to working with the MHRA as we progress AUTO4 through the clinic and to providing an interim update on the Phase 1 program later this year."

About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile (TDP) document to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.

Immunomic Therapeutics Announces License Agreement With Lineage Cell Therapeutics for Cancer Immunotherapy

On April 20, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported a worldwide license and development collaboration agreement with Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions (Press release, Immunomic Therapeutics, APR 20, 2021, View Source [SID1234578260]). The collaboration will generate a novel product candidate derived from Lineage’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to an upfront payment of $2 million paid in the first year and development and commercial milestones totaling $67 million across multiple indications. Lineage also will be eligible to receive royalties up to 10% on future product sales.

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"We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM," commented Dr. William Hearl, CEO of ITI. "Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs."

"The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer," stated Brian Culley, Lineage CEO. "This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC."

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain "de novo" or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

Cerus Corporation to Release First Quarter 2021 Financial Results on May 4, 2021

On April 20, 2021 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2021 financial results will be released on Tuesday, May 4, 2021, after the close of the stock market (Press release, Cerus, APR 20, 2021, View Source [SID1234578259]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8668508. The replay will be available approximately three hours after the call through May 18, 2021.

JOHNSON & JOHNSON REPORTS 2021 FIRST-QUARTER RESULTS

On April 20, 2021 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2021 (Press release, Johnson & Johnson, APR 20, 2021, View Source [SID1234578257]).. "Johnson & Johnson delivered a strong first quarter performance led by the above market growth of our Pharmaceutical business and continued recovery in Medical Devices," said Alex Gorsky, Chairman and Chief Executive Officer "The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business and the dedication of the 135,000 employees of Johnson & Johnson who strive every day to profoundly change the trajectory of health for humanity and make healthier communities for everyone, everywhere."

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FIRST-QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined 2.9%* primarily driven by negative prior year comparisons related to the COVID-19 pantry loading in Q1 2020, mainly in over-the counter products. Partially offsetting the decline is growth in LISTERINE in oral care products, JOHNSON’S BABY in baby care products, international skin health/beauty products and NICORETTE in international over-the-counter products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.4%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. This growth was partially offset by biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 8.8%*, and reflects the benefit of market recovery from COVID-19 impacts in the prior year. Contributors to growth were electrophysiology products in the Interventional Solutions business, worldwide biosurgery and energy products, and international endocutters in Advanced Surgery, wound closure products in General Surgery, contact lenses and surgery in the Vision business and trauma products in Orthopaedics; partially offset by knee products in Orthopaedics.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

FULL-YEAR 2021 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.