On May 2, 2022 Fresenius Kabi reported it has introduced Bortezomib for Injection, a new generic equivalent to Velcade in the U.S. and the newest addition to the most comprehensive injectable oncology portfolio in the industry (Press release, Fresenius Kabi Oncology, MAY 2, 2022, View Source [SID1234613323]).

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Fresenius Kabi Bortezomib for Injection is available in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use.

Fresenius Kabi Bortezomib for Injection is an affordable treatment option for adult patients with multiple myeloma and mantle cell lymphoma. Multiple myeloma represents nearly 2 percent of all new cancer cases in the U.S. and is expected to double in 20 years.1 Mantle cell lymphoma represents approximately 5 percent of all non-Hodgkin’s lymphoma diagnoses annually, and there are approximately 4,000 new cases each year.2,3

"Adding a generic equivalent Bortezomib for Injection to our expansive oncology portfolio reflects our continued plan of expanding access to affordable cancer therapies," said John Ducker, president and CEO of Fresenius Kabi USA. "We’re pleased to be able to provide an affordable option to patients and we are especially pleased that Fresenius Kabi Bortezomib for Injection is produced at one of our U.S. facilities."

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. Bortezomib for Injection is the newest example of the company’s commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

Bortezomib for Injection, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information
INDICATIONS AND USAGE

Bortezomib for Injection is a proteasome inhibitor indicated for:

treatment of adult patients with multiple myeloma
treatment of adult patients with mantle cell lymphoma
IMPORTANT SAFETY INFORMATION

Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. Bortezomib for Injection is contraindicated for intrathecal administration.

For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.

Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment.

Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration.

Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.

Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy.

Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected.

Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment.

Tumor Lysis Syndrome: Closely monitor patients with high tumor burden.

Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility.

Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected.

Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Most commonly reported adverse reactions (incidence ≥ 20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

On May 2, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows (Press release, Regeneron, MAY 2, 2022, View Source [SID1234613339]):

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BofA Securities Healthcare Conference at 1:20 p.m. PT (4:20 p.m. ET) on Tuesday, May 10, 2022
Goldman Sachs 43rd Annual Global Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Tuesday, June 14, 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.

On May 2, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that two abstracts have been accepted for poster presentations at the 25th Annual Meeting of the American Society of Gene & Cell Therapy, scheduled for May 16 – May 19, 2022, in Washington, DC (Press release, Lyell Immunopharma, MAY 2, 2022, View Source [SID1234613292]).

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The presentations will highlight preclinical data characterizing two investigational products in Phase 1 clinical development that incorporate Lyell technologies designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.

The first abstract presents preclinical data for LYL797 demonstrating that Gen-R and Epi-R can enhance and prolong anti-tumor functions of ROR1-targeting CAR T-cell therapy in solid tumor model systems. The second abstract presents preclinical data for LYL132 demonstrating that Epi-R creates populations of stemlike NY-ESO-1-targeting TCR T cells that lead to products with increased proliferative capacity and prolonged functional activity in the presence of persistent antigen exposure.

Details on the presentations are below:

Preclinical Development of LYL797, a ROR1-Targeted CAR T-Cell Therapy Enhanced with Genetic and Epigenetic Reprogramming for Solid Tumors

Session: Cancer – Immunotherapy, Cancer Vaccines II
Presentation Date, Time & Location: May 17, 5:30 – 6:30 PM, Hall D, Tu-166
Abstract number: 661
Epigenetic Reprogramming (Epi-R) Yields T-Cell Receptor Products with Improved Stemness, Metabolic Fitness, and Functional Activity in the Presence of Persistent Antigen Exposure

Session: Cancer – Targeted Gene and Cell Therapy II
Presentation Date, Time & Location: May 18, 5:30 – 6:30 PM, Hall D, W-241
Abstract: 1115
About LYL797 and LYL132

LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors. LYL797 incorporates Lyell’s novel Gen-R and Epi-R reprogramming technologies. The Phase 1 trial will assess LYL797 in patients with relapsed/refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). More information can be found on ClinicalTrials.gov by searching NCT05274451.

LYL132 (GSK4427296) is an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) being developed in collaboration with GSK. LYL132 incorporates Epi-R reprogramming technology and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development. The Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS). Lyell will manufacture LYL132 in its LyFE Manufacturing Center and GSK will conduct the Phase 1 trial. More information can be found on ClinicalTrials.gov by searching NCT04526509.

On May 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022 (Press release, Oncolytics Biotech, MAY 2, 2022, View Source [SID1234613308]).

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The accepted abstract (#364) is available on the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.

Results of this exploratory study described in the abstract show pelareorep’s potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep’s immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting’s embargo policies.

Details on the abstract and upcoming poster presentation are shown below.

Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – results from AWARE-1 study

Category: Biomarkers and translational research and precision medicine

Abstract Number: 364

Presentation Date: May 4, 2022

Presentation Time: 12:15 p.m. CET

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On May 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the availability of Shield, the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC) (Press release, Guardant Health, MAY 2, 2022, View Source [SID1234613324]). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC.

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Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.1 Today, one in three adults have not completed the recommended CRC screening even though colorectal cancer is curable if caught early. Barriers associated with currently available methods, such as a colonoscopy or a stool-based test, can make the process unpleasant, time-consuming and difficult to complete.2 With a simple blood draw, the Shield test overcomes these barriers because it requires no special preparation, no sedation, no dietary changes, no extra time away from family or work, and it can be completed as part of any patient office visit.3

The clinical performance of the Shield assay was validated using a set of 309 patient samples, including 92 with CRC, 51 with advanced adenomas and 166 normal cases. CRC patient samples were accrued across six unique cohorts collected in the U.S., Canada and the EU, and samples with advanced adenoma and normal cases were collected in the U.S. Subjects were balanced by age (a mean of 64 years old) and gender. The Shield assay demonstrated 91% sensitivity (detection rate) for CRC (95% confidence interval [CI]: 84% – 95%), including 90% for Stage I, 97% for Stage II, and 86% for Stage III CRC. The assay also demonstrated 20% sensitivity for advanced adenomas (95% CI; 11% – 32%) and 92% specificity (true negative rate) in normal cases.

"The availability of the Shield test represents a major milestone in our commitment to transform cancer screening. We have developed highly sensitive technology to detect early-stage cancers with a simple blood draw," said AmirAli Talasaz, Guardant Health co-CEO. "Colorectal cancer screening is the start of this journey. We will soon expand into multi-cancer screening, including lung, pancreas and others, where we believe cancer screening can save lives."

Why CRC screening compliance matters

More than 75% of people who die from CRC today are not up to date with recommended screening.4 Cancer underscreening is an important factor contributing to the high cancer mortality rate in underserved populations. For example, in the area of CRC, only 59% of individuals age 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings, compared to 68% of individuals who are white.5

"The value of colorectal cancer screening is well-established for individuals at average risk, age 45 and older," said J. Leonard Lichtenfeld, MD, MACP, Chief Medical Officer, Jasper Health. "But the benefits of screening have been limited due to the suboptimal completion rates of stool tests and colonoscopy. A high-sensitivity test that can be completed with a convenient blood draw during any healthcare provider visit can help patients overcome the barriers to adherence and help healthcare professionals identify more cancers at their earliest stages, when they are most treatable."

"Colorectal cancer is largely preventable if caught early, yet barriers to screening tests remain. It can be especially challenging for underserved populations to get screened. These barriers include lack of healthcare access, limited capacity in healthcare systems, transportation challenges, childcare, and lack of paid leave from work," said Anjee Davis, MPPA, president of Fight Colorectal Cancer. "As the research continues to progress for blood-based tests, the availability of a test like this is a welcomed addition to the tools we can use to prevent cancer. This has the potential to improve access to screening for underserved populations and dramatically improve overall screening rates."

How the Shield assay was developed

The Shield test detects early signs of CRC signals in the bloodstream. The assay was developed using multiple cohorts comprising 2,089 subjects with CRC, 357 with advanced adenoma and 3,757 normal subjects. The samples were collected within both prospective screening collections designed to capture the intended use population and retrospective case-control cohorts designed to enrich for subjects with CRC.

Where the Shield test is available currently

Shield is now available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.

What’s next for the Shield test

This year Guardant Health plans to share results of the ECLIPSE clinical study (NCT04136002) to demonstrate the performance of the Shield test to detect early signs of CRC in individuals ages 45-84 who are at average risk. The prospective, multi-site registrational study is one of the largest cancer screening studies of its kind, with enrollment of more than 12,750 patients from across the U.S. Subject to positive results, the study will support a premarket approval (PMA) submission to the U.S. Food and Drug Administration.