On June 3, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with relapsed or refractory multiple myeloma (Press release, Arcellx, JUN 3, 2022, View Source [SID1234615549]). The clinical results are being presented during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Evaluable for efficacy and safety analysis were 31 patients, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 million CAR+ T cells, n=6), the second dose level (300 million CAR+T cells, n=6), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 100 million CAR+T cells (n=19). All patients enrolled in the study have poor prognostic factors with 21 of 31 (68%) patients penta-refractory, 12 of 31 (39%) extramedullary disease (EMD), and all 31 patients having had at least three prior treatments.

The interim CART-ddBCMA clinical results (May 3, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

Of the 31 evaluable patients with median follow-up of 12.1 months
100% overall response rate (ORR) achieved in all patients per International Myeloma Working Group criteria
22 of 31 (71%) evaluable patients achieved complete response (CR) or a stringent complete response (sCR)
29 of 31 (94%) patients achieved > very good partial response (VGPR)
2 of 31 (6%) patients achieved a partial response (PR)
12 of 31 (39%) with extramedullary disease
13 of 16 patients (81%) dosed more than 12 months ago reached CR/sCR; 8 (50%) with EMD; 9 (56%) remain in ongoing response with a median follow up of 17.7 months
Conversions to sCR have occurred as early as 1 month and also at ≥12 months
CART-ddBCMA dosed at RP2D (100 million CAR+T cells) continues to be well-tolerated
Toxicities including CRS and ICANS have been manageable, and all resolved with standard management at both dose levels
No cases of delayed neurotoxicity events or parkinsonian symptoms
No cases of grade 3 (or greater) CRS and only one case (4%) of grade 3 ICANS event with no additional cases from previously reported.
Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "The demand for clinically meaningful and safe CAR-T therapies outweighs what’s currently available to multiple myeloma patients. It is encouraging to see these data continue to demonstrate deep responses and provide a benefit to patients. I look forward to enrolling patients in the Phase 2 pivotal study."

"We’re excited by these long-term results, particularly given the challenging patient demographics, and believe these promising results reflect the potential for our lead program, CART-ddBCMA, to be a best-in-class treatment for patients with multiple myeloma," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "We believe there’s a significant unmet need for cell therapies and we’re committed to providing physicians with a safe and effective treatment option for multiple myeloma patients. We’re honored to have our data presented at ASCO (Free ASCO Whitepaper) by Dr. Frigault and look forward to beginning enrollment in our Phase 2 pivotal study by the end of this year as the next step in the path towards regulatory approval."

The presentation can be accessed on the company’s corporate website here.

Oral Presentation Details:
Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Mass General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003

Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Sunday, June 5, 2022, at 7:00 p.m. CDT. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

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.