According to hematologists/oncologists, the current referral processes at tertiary sites have made it challenging to refer patients for chimeric antigen receptor (CAR) T-cell therapy. Other challenges identified with the referral process may also limit future outpatient CAR T-cell administration, according to the physicians surveyed.

The community physicians were a part of a cross-sectional survey conducted by Cardinal Health Specialty Solutions with the overarching goal of understanding how physicians perceive barriers to in-office CAR T-cell infusion and the factors that physicians consider when deciding to refer patients to undergo CAR T-cell therapy at a tertiary site.

CAR T-cell therapy is a new and innovative treatment approach that has been FDA approved in multiple hematologic malignancies, and because of its importance in treatment for hematologic malignancies, the surveyors though it important to gather data from the physician population. Further, there is a known disparity around the availability of CAR T-cell therapy in rural vs suburban settings that has not been well described in prior research.

This is observational research, which Cardinal has had more than a decade experience conducting. Some of that research actually does require physicians abstracting charts of patients. In some cases, it's combining that charge abstraction with understanding physician perceptions and physicians experiences. And so, we're able to not only know and look at the sequence of events, but we're also able to address the why behind those choices and those sequence of events. So, the work that we do is often trying to get physicians to give us that firsthand account. What was the patient experience? What led you to make this choice in treatment? What were the potential barriers to exercising that choice of treatment? What were the patient outcomes from that choice? explained Bruce Feinberg, DO, vice president, chief medical officer Cardinal Health Specialty Solutions, in an interview with Targeted Oncology. Often, we don't get that full story because when we're looking at only the clinical trials, we really see just that episode of care around the treatment itself, we see what happened at that institution when the CAR T cells were administered, not the story that led up to it or the story that follows when those patients returned to the community.

Characteristics of the physician population showed that 22.1% were from large, privately owned community practices, 13.2% were from small, privately owned community practices a, 5.9% were from medium, privately owned, community practices, and 1.5% were from solo, privately owned, community practices.The population also included physicians from academic centers or affiliated teaching hospitals (32.4%), community-based hospitals (7.4%), and medical centers or cancer centers (2.9%).

In terms of primary medical specialty, the majority of the physicians who responded to the survey were hematologists (64.7%), with the rest being either medical oncologists (33.8%), or other (1.5%). The mean years in practice among the survey responders was 9.7 years (range 2-43).

According to the survey results, most physicians (39%) referred 2 to 5 patients to a certified CAR T-cell treatment center to receive commercially available and FDA-approved CAR T cells in the past 3 years. Notably, 27% of physicians did not refer any patients to received CAR T-cell therapy, 20% referred 1 patient, 4% referred 6 to 10 patients, another 4% referred 11 to 15 patients, and 6% referred greater than 15 patients.

Physicians have 9 options for which type of CAR T-cell treatment center they are most likely to refer patients to and why. The top 4 responses showed that center reputation and location were the key factors.

Other factors, such as quick responses from the referral center, a CAR T-cell therapy supported by more published research, recommendations from colleagues, knowledge of CAR T-cell therapy, and patient eligibility, were less impactful on the physicians decision making.

In terms of the second survey goal, physicians have 5 options of CAR T-cell administration setting they utilize. Forty-seven percent of responders said their practice does not administer CAR T-cell therapy, 25% administer them at the hospital and have no intention on performing in-office infusions, 20% administer in the hospital but are considered in-office infusion, 6% perform in-office CAR T-cell therapy infusions, and 2% do both hospital and in-office infusions.

The top barriers to performing in-office CAR T-cell therapy administration were the ability to manage acute/immediate complications of treatment (78%), concerns around in-patient hospitalization within 2 hours after CAR T-cell infusion (66%), as well as lack of knowledge of the infusion process or CAR T cells, challenges with billing and reimbursement, and prior authorization/payer approval (38% each).

The barriers that we have witnessed are those barriers we've seen before. [The barriers are] having an educated community workforce of healthcare providers who are knowledgeable about these treatments, an academic, tertiary care environment, where they remove all the barriers to those patient referrals, and hopefully patients who understand to some degree that complexity of the program, so that they will be willing to undergo consent for those procedures. Each of those barriers exist, but each of those barriers has been seen before, and we can really rely on past experiences to help guide us forward, said Feinberg.

Because few practices are performing in-office CAR T-cell administration and there is a growing interest in doing so, Feinberg et al recommend stakeholder alignment to address the concerns of the oncology population.

REFERENCE:

Pink S, Deune-Smith Y, Klink AJ, et al. Community hematologist/oncologist (CH/O) barriers to CAR T referral and concerns with possible in-office car-t administration. Presented at: 2022 International Society for Pharmacoeconomics and Outcomes Research; May 15-18, 2022. Washington, DC. Abstract HSD44.

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Community Providers Face Hurdles With CAR T-Cell Therapy Referrals and In-Office Infusion - Targeted Oncology

-- Largest Analysis Examining Use of CAR T-cell Therapy Across Race and Ethnicity --

-- Black or African American Patients Experienced Longer Time from Diagnosis to Infusion Compared to White Patients, Possibly Impacting Overall and Complete Response Rates; More Study Warranted --

-- Clinical Trials of Yescarta in the U.S. and Real-World Use from CIBMTR Registry Show Consistent Participation of Approximately 5% Black or African American Patients --

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced 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). 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) Annual Meeting (Abstract #7571).

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 orAfrican American

Asian

White

Hispanicor 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], 0.240.69) and (OR 0.55; 95% CI 0.320.93), 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 0.240.87) and Black or African American patients (HR 0.39; 95% CI 0.170.88). 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 0.290.96 vs. White) and Hispanic or Latino patients (OR 0.51; 95% CI 0.310.85 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 Kites 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:

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

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 http://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.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Kite and Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Yescarta; the risk that physicians and patients may not see the potential benefits of Yescarta; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com.

Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the companys website at http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220603005447/en/

Jacquie Ross, Investorsinvestor_relations@gilead.com

Anna Padula, Mediaapadula@kitepharma.com

Source: Gilead Sciences, Inc.

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Yescarta CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity - Gilead...

For certain side effects of complex and lifesaving medical procedures, care teams can be left with limited and risky treatment options, but a program at UW Health is changing that using patients own cells as living therapeutics.

In 2017, the UW Program for Advanced Cell Therapy (PACT), in partnership with the UW Carbone Cancer Center, began examining this possibility and recently treated its first patients in a first-of-its-kind clinical trial to treat dry mouth technically termed xerostomia which is a serious side effect that can arise after radiation therapy in head and neck cancer patients.

Emily Kumlien(608) 516-9154ekumlien@uwhealth.org

What seems like a minor annoyance on a hot day is a common and major hindrance to quality of life for patients following radiation treatment, according to Dr. Jacques Galipeau, director, PACT.

Patients who have dry mouth struggle to eat, sleep and speak, on top of the pain, fatigue and tooth decay it can cause, he said. Now we have something that has the potential to treat this without any serious side effects.

The new therapy uses a special kind of cell from the bodys bone marrow called interferon-gamma activated marrow stromal cells. Once the cells are collected with a needle from the liquid part of bone marrow (the spongy material inside bones that generates red blood cells), they are processed and a crop of cells are grown at PACTs pharmaceutical-grade cell manufacturing facility at University Hospital. Then, the cells are injected into saliva-producing glands to replenish the tissue and restore function.

The PACT dry mouth trial is led by Dr. Randy Kimple, associate professor of human oncology, UW School of Medicine and Public Health. Kimple and his team will enroll about 20 people in the trial.

Currently, the only options to help these patients is to ask them to consume specifically prepared food, suck on sugar-free candy and drink water frequently, Kimple said.

We can do better than this for these patients, he said. We are at the starting line, and if this proves safe, we will start testing efficacy and soon we hope to have the best possible alternative to make their lives as comfortable as we can.

Philanthropy can help expand the scope of this studys future phases, and other novel clinical trials conducted by PACT researchers. Other studies include research investigating the use of mesenchymal stromal cells to prevent cytomegalovirus reinfection in kidney transplant and bone marrow transplant patients, for example. The impact of such research is tremendous but it takes resources to make it a reality, Galipeau said.

The help of outside funding is critical to our work, he said. We have the ideas and the technology, but to help the largest number of people the fastest, its going to take investment.

Philanthropy helps expand research of this type, and highlights the vital importance of the recently announced Wisconsin Medicine philanthropic campaign designed to invest in the future of health and enable researchers and providers to revolutionize cell therapy and other medical science and health care.

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The future of cell therapy: Novel study tests treatment for radiation-induced dry mouth - University of Wisconsin School of Medicine and Public Health

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Yescarta Car T-Cell Therapy Demonstrates Consistent Survival Outcomes And Safety In Real-World Setting Re - Benzinga

Latest analysis from the Cancer Research Institute of the global landscape of cellular immunotherapies, including R&D trends and real-world usage, highlights key challenges including effective solid tumor targeting, manufacturing complexities, and commercial access to approved therapies

Newswise NEW YORK, June 1, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, announced today the publication of its newest analysis of the global landscape of cellular immunotherapies, including R&D trends and real-world usage data. The report, published today in Nature Reviews Drug Discovery, highlights trends in cellular immunotherapy for cancer including top modalities, targets, clinical development, and data from patients receiving CAR-T therapies in clinical practice. This report is an update to CRIs prior cellular immunotherapy landscape analysis published in July 2021.

In this analysis, author Samik Upadhaya, Ph.D., assistant director of scientific affairs and member of the Anna-Maria Kellen Clinical Accelerator team at CRI, and colleagues provide an update on the overall status of the cellular cancer immunotherapy landscape as well as observations on key changes within the field including clinical practice. Findings include:

This latest report from the Cancer Research Institute, titled, Landscape of cancer cell therapies: trends and real-world data, was generated in collaboration with IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, which provided the authors with access to IQVIAs proprietary clinical trials database. The report is part of a suite of CRI-owned immuno-oncology landscape analyses that includes reports on cell therapy drug development and the broader IO landscape including clinical development of checkpoint inhibitors, cancer vaccines, and oncolytic viruses in addition to bispecific antibodies and other immunomodulators.

To access an interactive dashboard of the Cancer Research Institutes cancer cell immunotherapy report, visit the CRI website at cancerresearch.org/cell-therapy.

Reference: Saez-Ibaez AR et al. Landscape of cancer cell therapies: trends and real-world data. Nat. Rev. Drug Discov. https://www.nature.com/articles/d41573-022-00095-1

About the Cancer Research Institute The Cancer Research Institute (CRI), established in 1953, is a highly rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $474 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

About the Anna-Maria Kellen Clinical Accelerator CRIs clinical program, the Anna-Maria Kellen Clinical Accelerator is a unique academic-nonprofit-industry collaboration model that serves an as incubator that delivers multicenter clinical trials of promising new immunotherapy combinations. CRIs venture philanthropy fund supports clinical trials within the program, which fosters a collaborative environment that enables scientists to advance their most ambitious research ideas by accelerating studies that one group or company could not do alone. To learn more, go to cancerresearch.org/clinical-accelerator.

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Cellular Cancer Immunotherapy Clinical Development Continues to Evolve and Expand with Novel Technologies and Targets, New Report From Cancer Research...