On June 3, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported primary results from the Phase 3 SHINE study (Abstract #7502), which demonstrated that the combination of once-daily oral IMBRUVICA (ibrutinib) plus bendamustine-rituximab (BR) and rituximab maintenance significantly reduced the risk of disease progression or death by 25 percent compared to patients who received placebo plus BR and rituximab maintenance in patients aged 65 years or older with newly diagnosed mantle cell lymphoma (MCL) (Press release, Johnson & Johnson, JUN 3, 2022, View Source [SID1234615548]).1 This study is one of the largest clinical trials ever conducted in first-line MCL and the first for a Bruton’s tyrosine kinase inhibitor (BTKi).1 The data are being presented in an oral session and featured in a press briefing during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and were published in The New England Journal of Medicine today. The data will also be presented as an oral presentation at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

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MCL is a type of aggressive, rare non-Hodgkin lymphoma (NHL) that is incurable and difficult to treat.2 It commonly affects people over the age of 65, who typically cannot tolerate intensive chemoimmunotherapy and stem cell transplantation, resulting in poor clinical outcomes and contributing to the need to develop additional treatment options for these patients.2

"There is an urgent need to improve outcomes for older patients with MCL," said Michael L. Wang, M.D., Professor, Department of Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center and principal study investigator.‡ "Given the median progression-free survival of 6.7 years, the ibrutinib combination demonstrated the potential to be a first-line treatment in this population."

The Phase 3 SHINE (MCL3002) study (NCT01776840) – sponsored by Janssen Biotech, Inc., in collaboration with Pharmacyclics LLC, an AbbVie Company – enrolled 523 patients aged 65 years or older with newly diagnosed MCL.1 All participants were randomly assigned to receive IMBRUVICA (560 mg orally daily until progression or unacceptable toxicities) or placebo plus BR for a maximum of six 28-day cycles; participants with a complete response (CR) or partial response (PR) continued to receive maintenance therapy with rituximab every second cycle for a maximum of 12 additional doses.1 IMBRUVICA or placebo was administered daily until progressive disease or unacceptable toxicity.1

The SHINE study met its primary endpoint of progression-free survival (PFS). Key findings from the Phase 3 SHINE study include:

With a median follow-up of 84.7 months, the IMBRUVICA plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS (6.7 years) vs. BR (4.4 years).1 This is a 50 percent improvement as compared to patients treated with BR and rituximab maintenance (stratified hazard ratio [HR]: 0.75, 95 percent confidence interval [CI], 0.59-0.96; p = 0.011).1
Key secondary endpoints included: CR, time-to-next treatment (TTNT), overall survival (OS), and overall response rate (ORR).1
A CR was achieved in 171 patients (65.5 percent) in the IMBRUVICA plus BR arm and 151 patients (57.6 percent) in the placebo arm (p = 0.057).1 The rates of objective response were similar between the two arms (IMBRUVICA plus BR: 89.7 percent; placebo: 88.5 percent).1
Median TTNT was not reached in the IMBRUVICA plus BR arm, the median TTNT was 92 months in the placebo plus BR arm (p < 0.001).1
OS was similar between treatment arms and median OS was not reached in either treatment arm (p = 0.06).1,3
"More than eight years since its first FDA approval, IMBRUVICA has treated over 250,000 patients globally, fundamentally changing the treatment paradigm for complex B-cell malignancies," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "The Phase 3 SHINE study reinforces our continued commitment to the development of IMBRUVICA to provide meaningful differences and change outcomes for patients with B-cell malignancies where high unmet medical needs still remain."

The safety profile of the IMBRUVICA plus BR regimen was consistent with known safety profiles of IMBRUVICA as well as BR.1 Across all treated patients, the most common Grade 3/4 Adverse Events (AEs) ≥5 percent were neutropenia (IMBRUVICA plus BR: 47.1 percent; BR: 48.1 percent), pneumonia (IMBRUVICA plus BR: 20.1 percent; BR:14.2 percent), anemia (IMBRUVICA plus BR: 15.4 percent; BR: 8.8 percent), thrombocytopenia (IMBRUVICA plus BR: 12.7 percent; BR: 13.1 percent), rash (IMBRUVICA plus BR: 12 percent; BR: 1.9 percent), and diarrhea (IMBRUVICA plus BR: 6.9 percent; BR: 3.8 percent).1 Treatment-emergent AEs of clinical interest with BTKis included atrial fibrillation (AF) which was reported in 13.9 percent of patients in the IMBRUVICA plus BR arm and 6.5 percent in the placebo arm; hypertension in 13.5 percent and 11.2 percent; major bleeding in 5.8 percent and 4.2 percent; any bleeding 42.9 percent and 21.5 percent; and arthralgia in 17.4 percent and 16.9 percent, respectively.1

IMBRUVICA is currently approved globally for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.4 Within the U.S., this indication is approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

About IMBRUVICA
IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. IMBRUVICA blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments and inhibits their proliferation.5,6,7

IMBRUVICA is approved in more than 100 countries for at least one indication and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, with over 11 years evaluating the efficacy and safety of IMBRUVICA.

IMB­RUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include indications to treat adults with CLL/SLL with or without 17p deletion (del17p), and adults with Waldenström’s macroglobulinemia (WM), and adult patients with previously treated mantle cell lymphoma (MCL)*, as well as to treat adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy†, and adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.4

†Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

The National Comprehensive Cancer Network (NCCN), recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and has Category 1 treatment status for treatment-naïve patients without deletion 17p/TP53 mutation and as a preferred treatment for treatment-naïve patients with deletion 17p/TP53 mutation. The NCCN Guidelines also recommend IMBRUVICA, with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, as a Category 1 preferred regimen for both untreated and previously treated WM patients, and as a preferred regimen for relapsed/refractory MZL.7

For more information, visit www.IMBRUVICA.com.

IMBRUVICA IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4.2% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA in 27 clinical trials. Bleeding events of any grade including bruising and petechiae occurred in 39%, and excluding bruising and petechiae occurred in 23% of patients who received IMBRUVICA, respectively.

The mechanism for the bleeding events is not well understood.

Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA without antiplatelet or anticoagulant therapy experienced major hemorrhage. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA. Monitor for signs and symptoms of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections. Monitor and evaluate patients for fever and infections and treat appropriately.

Cardiac Arrhythmias, Cardiac Failure and Sudden Death: Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA. Deaths due to cardiac causes or sudden deaths occurred in 1% of 4,896 patients who received IMBRUVICA in clinical trials, including in patients who received IMBRUVICA in unapproved monotherapy or combination regimens. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities. Patients with cardiac comorbidities may be at greater risk of these events.

Grade 3 or greater ventricular tachyarrhythmias were reported in 0.2%, Grade 3 or greater atrial fibrillation and atrial flutter were reported in 3.7%, and Grade 3 or greater cardiac failure was reported in 1.3% of 4,896 patients who received IMBRUVICA in clinical trials, including in patients who received IMBRUVICA in unapproved monotherapy or combination regimens. These events have occurred particularly in patients with cardiac risk factors including hypertension and diabetes mellitus, a previous history of cardiac arrhythmias, and in patients with acute infections.

Evaluate cardiac history and function at baseline, and monitor patients for cardiac arrhythmias and cardiac function. Obtain further evaluation (e.g., ECG, echocardiogram) as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Manage cardiac arrhythmias and cardiac failure appropriately, follow dose modification guidelines, and consider the risks and benefits of continued IMBRUVICA treatment.

Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA in clinical trials. Grade 3 or greater hypertension occurred in 8% of patients. Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months). Monitor blood pressure in patients treated with IMBRUVICA, initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA as appropriate, and follow dosage modification guidelines for Grade 3 or higher hypertension.

Cytopenias: In 645 patients with B-cell malignancies who received IMBRUVICA as a single agent, grade 3 or 4 neutropenia occurred in 23% of patients, grade 3 or 4 thrombocytopenia in 8% and grade 3 or 4 anemia in 2.8%, based on laboratory measurements. Monitor complete blood counts monthly.

Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (3.9%), occurred among the 1,476 patients who received IMBRUVICA in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥30%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal pain (38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%).

The most common Grade ≥ 3 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia (8.2%), and hypertension (8.0%).

Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Co-administration of IMBRUVICA with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Increased ibrutinib concentrations may increase the risk of drug-related toxicity. Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if strong inhibitors are used short-term (e.g., for ≤ 7 days). Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain strong or moderate inhibitors of CYP3A. See dose modification guidelines in USPI sections 2.3 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe hepatic impairment. In patients with mild or moderate impairment, reduce recommended IMBRUVICA dose and monitor more frequently for adverse reactions of IMBRUVICA.

On June 3, 2022 Taiho Oncology, Inc. reorted updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis (Press release, Taiho, JUN 3, 2022, View Source [SID1234615547]). The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions . These data were presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"Updated data from the pivotal FOENIX-CCA2 Phase 2 trial reinforce the durable efficacy and continued tolerability of futibatinib in previously treated patients with locally advanced or metastatic iCCA harboring FGFR2 gene rearrangements including fusions," said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center in Boston, and lead investigator on the study. "These data add to the body of evidence supporting futibatinib as a potential treatment option for patients living with this rare cancer that traditionally has had limited treatment options."

Each year, approximately 8,000 individuals in the U.S. are diagnosed with cholangiocarcinoma (CCA),1 a cancer of the bile ducts of the liver. Worldwide, approximately 0.3-6 people per 100,000 individuals live with CCA.2 CCA is mainly seen in people 65 years of age or older,3 and treatment options are limited. FGFR2 gene rearrangements, including gene fusions, which can form a hybrid gene and promote tumor proliferation, are observed more frequently in the iCCA patient population, with approximately 10-16% of patients having tumors with these rearrangements.4,5,6,7,8

The Phase 2 FOENIX-CCA2 trial included 103 patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy. Patients received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR) as assessed by independent central review.

At the time of the data cutoff for this updated analysis, with a median follow-up of 25.0 months, the ORR was 41.7%. Responses were durable, with a median duration of response (DoR) of 9.5 months (74% of responses lasted greater than six months). In addition, the disease control rate was 82.5%, median progression-free survival was 8.9 months and median overall survival was 20.0 months.

The most common treatment-related adverse events (TRAEs) were hyperphosphatemia (85%), alopecia (33%), dry mouth (30%), diarrhea (28%), dry skin (27%) and fatigue (25%). Most TRAEs were of mild or moderate intensity and manageable. There were two patients with grade 4 TRAEs and four patients discontinued treatment due to TRAEs. No treatment-related deaths occurred.

"Taiho Oncology remains committed to addressing unmet treatment needs in patients living with a broad range of cancers, and these data from the FOENIX-CCA2 trial demonstrate the clinical activity of futibatinib," said Volker Wacheck, Vice President, Clinical Development, Taiho Oncology, Inc. "We are looking forward to continued discussions with regulatory authorities around this important investigational therapy."

In March 2022, the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic CCA harboring FGFR2 gene rearrangements, including gene fusions. The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022. The FDA previously granted Breakthrough Therapy Designation (BTD) for futibatinib in CCA in February 2021.

About Futibatinib
Futibatinib (TAS-120) is an investigational, oral, potent, selective and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. This irreversible binding to the ATP binding pocket of FGFR1-4 results in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased cell death in tumors with FGFR1-4 genetic aberrations. Futibatinib is being studied alone as a potential treatment for patients with advanced solid tumors with FGFR1-4 genomic aberrations, including cholangiocarcinoma, or in combination with chemotherapy or other therapies.

On June 3, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its comprehensive genomic profiling offerings with xF+, a new non-invasive, liquid biopsy panel of 523 genes, focused on pathogenic mutations in cell-free DNA (cfDNA) (Press release, Tempus, JUN 3, 2022, View Source [SID1234615546]). The test will originally be available on a limited basis alongside xF, Tempus’ 105-gene liquid biopsy assay, with a broader launch slated for later this year.

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Tempus expects that the xF+ panel will be the largest clinically available liquid biopsy panel on the market, covering more genes with single nucleotide variants and indels reported in all genes, plus expanded coverage of translocations/gene rearrangements, and copy number variants. It can also measure blood-based tumor mutational burden (bTMB) and microsatellite instability (MSI), predictive biomarkers for response to various cancer immunotherapies. Liquid biopsies can be useful for parallel testing with tumor tissue to provide a more comprehensive detection of actionable alterations than tissue or liquid biopsy testing alone. Additionally, follow-up liquid biopsy testing can uncover new gene alterations and resistance mechanisms (clonal evolution), sample tumor DNA shed from metastatic sites, and can be used to longitudinally monitor disease burden and response to treatment.

"xF+ further strengthens Tempus’ range of genomic profiling capabilities, offering physicians a broad-panel liquid biopsy option for patients in which a comprehensive, non-invasive test is appropriate," said Nike Beaubier, MD, Vice President of Translational Medicine at Tempus. "We are excited to introduce what we believe is the largest clinically available liquid biopsy panel to provide even more insights on pathogenic mutations in cfDNA."

xF+ is the latest addition to Tempus’ library of assays, which includes xF; xT, an assay that analyzes 648 genes in solid tumor and hematologic malignancies; xG, a 52-gene panel that specifically identifies genetic variants associated with hereditary cancer syndromes and inherited risk of cancer; xG+, a 88-gene multi-cancer panel that covers genes associated with both common and rare hereditary cancer syndromes; and xE, an assay that analyzes the whole exome. All panels are run in Tempus’ CAP-accredited, CLIA-certified robotic sequencing labs.

On June 3, 2022 GE Healthcare’s innovative suite of diagnostic and treatment technologies reported that are designed to help improve detection, clinical efficiency, operational efficiency, and outcomes for cancer patients (Press release, GE Healthcare, JUN 3, 2022, View Source [SID1234615545]).

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"GE Healthcare is collaborating with health systems to bring innovation in oncology to deliver better and more effective patient care and outcomes," said Catherine Estrampes, President & CEO, U.S. and Canada at GE Healthcare. "Oncology treatments are rapidly evolving, making it difficult for clinical teams to adapt. Whether it’s the thousands of active clinical trials or the accelerating number of approved immunotherapies, clinical care providers need solutions that combine patient data from EMRs, imaging, biomarkers and other diagnostics with molecular profiling to enable the most informed care decisions."

Precision imaging is fundamental to determining the size, shape and characteristics of tumors and differentiating between healthy tissues. As a global leader in medical imaging solutions, GE Healthcare continues to demonstrate its commitment to advancing precision medicine through collaborations with technology partners around the world.

At this year’s ASCO (Free ASCO Whitepaper) 2022 annual meeting, GE Healthcare will demonstrate how a collection of strategic partnerships and collaborations announced over the past year will help advance cancer care and offer medical practitioners the solutions, imaging tools and support they need to improve patient-centered care and advance the practice of precision medicine.

"GE Healthcare’s innovative suite of predictive, prescriptive and precision oncology solutions helps support the delivery of more efficient, precise and personalized care across the cancer care continuum. Through our collaboration with other technology leaders, we can continue to elevate oncology innovation and help improve clinical, operational, and patient outcomes at every state and at every step of the care pathway," said Ben Newton, MD, General Manager for GE Healthcare Oncology Solutions.

Below are highlights from oncology announcements over the past year:

RaySearch: GE Healthcare has announced its agreement with RaySearch Laboratories AB (publ), a leading radiation oncology software provider, to develop a new radiation therapy simulation and treatment planning workflow solution, designed to simplify how radiation will be targeted to shrink a tumor. Together the companies aim to combine Stockholm-based RaySearch’s advanced treatment planning systems with GE Healthcare’s leading multi-modality (CT/MR/molecular imaging) simulator systems to make cancer treatment faster and more precise. RaySearch’s software is used by over 800 clinics in more than 40 countries.1

Elekta: GE Healthcare and Elekta (EKTA-B.ST) have signed a global commercial collaboration agreement in the field of radiation oncology that enables the two companies to provide hospitals a comprehensive offering across imaging and treatment for cancer patients requiring radiation therapy. As many as 50–60 percent of all cancer patients require radiation therapy2 which requires high quality imaging and sophisticated delivery equipment and software to precisely target tumors while sparing healthy tissue. Combining GE Healthcare’s imaging solutions with Elekta’s radiation therapy solutions will result in an even more compelling offering for hospitals, and ultimately their patients across both developed and developing markets.

Minerva: GE Healthcare and Minerva Imaging have signed a strategic partnership to accelerate precision medicine and targeted radionuclide therapy (Theranostics). Radionuclide therapy is a form of precision medicine where a radioactive substance is administered through the bloodstream to specifically target cancer cells and irradiate them with the aim of helping to reduce potential side effects compared to traditional cancer therapies. The partnership is designed to facilitate the success of Minerva Imaging’s growth plans by establishing capabilities for in-house production of isotopes and CDMO services for radiopharmaceuticals. Minerva Imaging will be using cutting-edge technology from GE Healthcare to optimize new radiopharmaceuticals, including a cyclotron – a type of particle accelerator used to produce isotopes.

University of Cambridge: The University of Cambridge, Cambridge University Hospitals – including Addenbrooke’s Hospital, and GE Healthcare have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that will integrate cancer patient data from multiple sources into a single interface. The collaboration also supports the further development and integration of AI/Machine Learning pipelines that are already in development at the University of Cambridge. Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

Optellum: GE Healthcare and Optellum are working together to address one of the largest challenges in the diagnosis of lung cancer – helping providers determine the malignancy of a lung nodule, a suspicious lesion that may be benign or cancerous. Optellum is a leader in AI decision support for the early diagnosis and optimal treatment of lung cancer, and their Virtual Nodule Clinic can help clinicians identify at-risk patients and assess the likelihood of malignancy in a lung nodule through a radiomics score – which is key to determining whether biopsy is necessary and accelerating overall diagnosis. Virtual Nodule Clinic is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer3 – enabling clinicians to make optimal management decisions for patients with lung nodules.

Vysioneer VBrain: GE Healthcare is collaborating with Vysioneer to utilize artificial intelligence (AI) towards cancer care. Vysioneer’s FDA-cleared VBrain solution is an auto-contouring system that applies auto-contouring to the three most common types of brain tumors: brain metastasis, meningioma and acoustic neuroma. VBrain allows for greater precision for radiotherapy treatment planning and is vendor-neutral – integrating with different treatment planning systems by supporting data routing to and from DICOM nodes within a hospital network.

Spectronic Medical Synthetic CT, MR[4] auto-segmentation: GE Healthcare announced plans to integrate Spectronic Medical AB’s AI-based software to support more precise cancer treatment planning, providing an alternative to standard CT images in radiotherapy treatment planning. This AI solution and GE Healthcare’s advanced AIR Recon DL technology both offer deep learning solutions for the radiation therapy workflow. GE Healthcare’s AIR Recon DL is a deep learning image reconstruction technology that leverages raw data from the MR scanner to reduce image noise, enhance image quality and resolution, and shorten scan times, to provide high quality diagnostic images. Spectronic Medical’s AI-based solution is designed to convert standard MR images acquired by the GE scanner into synthetic CT images, providing clinicians with the CT images required for treatment planning, while also having the MR soft tissue details to accurately target lesions and help improve patient outcomes.[5]

Mirada RTx: As a part of their strategic collaboration to improve outcomes for patients, GE Healthcare and Mirada Medical are focusing on advancing automation and Artificial Intelligence (AI) technologies to enable faster, more consistent and more precise cancer radiotherapy treatment. To do so, the Mirada Medical RTx product has been integrated into the GE Healthcare AW Workstation and AW Server to enable enhanced cancer visualization and diagnostic capabilities. These integrations can result in increased automation to deliver improvements in care workflows and help drive efficiency and time savings.

SOPHiA GENETICS: GE Healthcare and SOPHiA GENETICS will be collaborating on opportunities in the healthcare market, including various initiatives and projects in the fields of digital oncology and radiogenomic analysis. The companies will initially work together on the creation of infrastructure to integrate data between GE’s Edison platform and the SOPHiA DDM platform, as well as co-marketing and pilot site recruitment across oncology and radiogenomics.

One-Stop Breast Clinic: Momentum continues around this rapid diagnostic breast cancer center model – with the first site in the United States now underway at St. Luke’s University Health Network in Pennsylvania, as well as new sites extending across the world in Colombia, Egypt, and France. GE’s One-Stop Clinic breast care model, originated from the pioneering Gustave Roussy Cancer Center in France, has been shown to improve clinical outcomes and dramatically speed up breast cancer diagnosis and treatment planning. This value-based, multi-modality care approach is designed to provide patients with a tightly coordinated journey from the initial appointment through diagnosis and treatment plan in one location and with one team – all in a significantly shorter timeframe. Since piloting the workflow in 2021, St. Luke’s has implemented the model and been able to reduce the time from screening to diagnosis and treatment to 36 hours or fewer.[6] In Colombia, One-Stop Clinic has dramatically transformed breast cancer care for women by reducing time to treatment by roughly 93%.[7]

Through these and a variety of additional solutions, GE Healthcare aims to further reinforce its role as a core partner in multidisciplinary cancer care and provide increasingly accessible, more precise, and high-value radiation therapy.

GE Healthcare will be exhibiting at ASCO (Free ASCO Whitepaper) 2022 Innovation Hubs – IH14 & IH16 from June 3 – June 7.

Registration for the GE Healthcare – SOPHiA GENETICS Innovation Symposium ‘Unlocking the Promise of Data-Driven Medicine in Cancer Care, Together’ with speakers from Vanderbilt-Ingram Cancer, GE Healthcare and SOPHiA GENETICS can be found here. GE Healthcare and Vanderbilt University Medical Center announced their partnership to enable safer and more precise cancer immunotherapies in 2019 and the symposium will share early progress and findings achieved to date. SOPHiA GENETICS will present the latest developments in their DEEP-Lung-IV Multimodal Clinical Study.

On June 3, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported findings from a safety and efficacy retrospective analysis by race and ethnicity from the ongoing post-authorization study of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) (Press release, Kite Pharma, JUN 3, 2022, View Source [SID1234615544]). In the largest real-world analysis of its kind evaluating data from the CIBMTR (Center for International Blood and Marrow Transplant Research), overall outcomes including overall survival (OS) and progression-free survival (PFS) rates were consistent with Yescarta in the real-world setting, regardless of race and ethnicity. The findings were presented today in an oral session during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #7571).

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The incidence of diffuse LBCL in the U.S. is 4.8 per 100,000 per year in non-Hispanic Black or African Americans and 7.1 per 100,000 per year in non-Hispanic Whites. Clinical trials of Yescarta in the U.S. have enrolled an average of 6% Black or African American patients, consistent with the roughly 5% of patients in the real-world CIBMTR registry.* Further research is ongoing to investigate whether or not there is under-representation by race and ethnicity in both clinical trials and the real-world usage of CAR T-cell therapy.

"The investigation of CAR T-cell therapy outcomes by race and ethnicity is important to the continued understanding of the impact of these innovative therapies, and an area in which there is a significant deficit in clinical trials and real-world studies published to date," said Frederick L. Locke, MD, lead author and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. "The results of this analysis are encouraging in that axi-cel was safe and effective regardless of race or ethnicity, and also warrant further investigation to understand the lower rate of response among Black or African American patients and the potential role of factors such as higher disease burden, disease biology and, importantly, differential access to care."

A total of 1,389 adult patients with LBCL treated with Yescarta in the commercial setting in the U.S. from October 2017 to August 2020 were included in the analysis. Race and ethnicity (Hispanic or Latino vs. not Hispanic or Latino) were self-reported and included: White (81%); Black or African American (5%); Asian (6%); American Indian or Alaska Native <1%; Native Hawaiian or other Pacific Islander <1%; More than one race <1%; Race not reported (7%). Eleven percent of patients evaluated self-identified as Hispanic or Latino.

At a median follow-up of 12.7 months, outcomes for objective response rate (ORR), complete response (CR), duration of response (DOR) at 6 months, PFS at 12 months, and OS were as follows:

Black or
African American

Asian

White

Hispanic
or Latino

Objective response rate (ORR)

57%

67%

74%

73%

Complete response (CR)

45%

53%

57%

55%

Duration of response (DOR; 6-month)

66%

81%

70%

71%

PFS at 12 months

36%

55%

48%

50%

OS at 12 months

62%

65%

63%

65%

Multivariable analyses found no statistical differences in OS and PFS across races. Efficacy outcomes across patients who were Hispanic or Latino and not Hispanic or Latino were also consistent. Among Black or African American patients, ORR and CR were lower compared to White patients [(Odds Ratio (OR) 0.40; 95% Confidence Interval [CI], 0.24–0.69) and (OR 0.55; 95% CI 0.32–0.93), respectively]. Black or African American patients, compared to White patients, were more likely to have moderate to severe pulmonary impairment (41% vs. 28%) and tended to have a longer time from diagnosis to infusion of Yescarta (≥12 months: 71% vs. 59%). DOR rates among Asian patients were more favorable compared to both White patients (Hazard Ratio (HR) 0.46; 95% CI 0.24–0.87) and Black or African American patients (HR 0.39; 95% CI 0.17–0.88). No differences in cytokine release syndrome (CRS; any grade) and Grade ≥3 CRS by race and ethnicity were observed. Asian patients (OR 0.52; 95% CI 0.29–0.96 vs. White) and Hispanic or Latino patients (OR 0.51; 95% CI 0.31–0.85 vs. not Hispanic or Latino) experienced a lower risk of Grade ≥3 ICANS (ASTCT consensus grade).

"As the global leader in CAR T-cell therapy, it is important to Kite that we support research to help better understand outcomes of CAR T-cell therapy across different races and ethnicities," said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. "Through ongoing data generation, increasing diversity in Kite’s clinical trials, and partnerships with patient advocacy organizations and community partners to reduce barriers to care, we are actively working to increase our understanding of CAR T-cell therapy in diverse populations and treatment settings."

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy. Yescarta was also approved by the FDA in April 2022 as the first CAR T-cell therapy for adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

*Average is based on combined enrollment in ZUMA-1 and ZUMA-7 trials. Terminology for self-reporting of race has changed during the time period of these trials.

About LBCL

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. The incidence of diffuse LBCL per 100,000 people per year in the U.S. is 4.8 in non-Hispanic Black or African American, 7.1 in non-Hispanic White, 6.8 in Hispanic or Latino, and 5.9 in Asian/Pacific Islander populations, respectively.

About Yescarta

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).
U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.