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Of all the health care regulations coming out of the current administration, the recent drug rebate proposal presents a new opportunity to significantly lower out-of-pocket prescription drug costs for Medicare patients. But like most things in health care, there is more complexity to the administration’s proposed changes to pharmaceutical company rebates than initially meets the eye.

The Administration's Drug Rebate Proposal: An Opportunity to Put Patients First

The first patient was enrolled in a phase 3 trial and was randomly assigned to receive treatment for non-metastatic uveal melanoma.

This type of melanoma forms in the uvea of the eye, or the area of the eye that makes the dark-colored pigment, according to the National Cancer Institute. Uveal melanoma is considered rare and is the most common type of eye cancer among adults.

Patients in the phase 3 ATOM trial will be randomly assigned to two groups: no treatment for observation or Kimmtrak (tebentafusp). The main goal is to evaluate the effectiveness of Kimmtrak in preventing or delaying relapse in patients with primary uveal melanoma at high risk of relapse, compared with observation.

Kimmtrak is a type of drug that binds to certain antigens on the surface of uveal melanoma cells. This helps the immune system destroy cancer cells, as defined by the National Cancer Institute.

“I am delighted that the first patient on ATOM has been recruited. This milestone reflects a very significant effort by the European Organisation for Research and Treatment of Cancer melanoma group trials team, colleagues at Immunocore and our trial sites,” Dr. Paul Nathan, consultant medical oncologist and ATOM study coordinator, said in a news release from Immunocore, the manufacturer of Kimmtrak. “The study addresses a key question — whether the benefit seen with [Kimmtrak] in HLA-A*02:01-positive patients with metastatic uveal melanoma will translate to a significant reduction in risk of relapse for patients who have received treatment for primary uveal melanoma and are at high risk of relapse.”

TIL Therapy Promising in Uveal Melanoma, Tool Predicts Responders

The study’s researchers are expected to enroll 290 patients with uveal melanoma who have previously received definitive treatment by surgery or radiation therapy, according to the release. Patients eligible for the study also have HLA-A*02:01-positive disease, adequate organ function and an ECOG performance status of 0 or 1.

Secondary goals within the study include overall survival, safety and tolerability. Additional goals researchers will evaluate are circulating tumor DNA to identify remaining cancer in the body and a comparison of health-related quality of life between the two treatment groups.

“Despite definitive local therapy, approximately 50% of patients will eventually relapse with metastatic disease. The goal of investigating adjuvant [Kimmtrak] following primary treatment is to prevent future recurrence,” Mohammad Dar, chief medical officer at Immunocore, said in the release. “Decreasing the likelihood of a patient relapsing following definitive therapy for their primary disease would be a groundbreaking advancement in treatment, given there are currently no standard treatment options available in this setting.”

 by the Food and Drug Administration in early 2022 for patients with unresectable (surgically unremovable) or metastatic uveal melanoma. The approval was based on findings from the phase 3 IMCgp100-202 trial, which included patients with metastatic uveal melanoma who were not previously treated. Patients in this study were randomly assigned to either receive treatment of Kimmtrak or investigator’s choice, including Yervoy (ipilimumab), Keytruda (pembrolizumab) or dacarbazine.

Side effects associated with Kimmtrak, based on the IMCgp100-202 trial, included fever in 4% of patients, rash in 18% and itching in 5%. Of note, cytokine release syndrome was reported in less than 1% of patients and was well managed.

For more news on cancer updates, research and education, don’t forget to 

subscribe to CURE®’s newsletters here.

The first patient was enrolled in a phase 3 trial for patients with non-metastatic uveal melanoma to either receive Kimmtrak or observation. 

Tumor

First Patient Enrolled Receives Kimmtrak in Phase 3 Uveal Melanoma Trial

Patients with B-cell acute lymphoblastic leukemia (B-ALL) and mantle cell lymphoma (MCL) experienced similar rates of non-relapse mortality and an acceptable safety profile with outpatient administration of lymphodepletion ahead of receiving Tecartus (brexucabtagene autoleucel) when compared with inpatient administration of lymphodepletion and Tecartus, results from a retrospective study presented at the 

Findings showed that patients administered lymphodepletion in the outpatient setting (28 patients) — irrespective of the setting for Tecartus infusion — experienced a 60-day non-relapse mortality rate of 3.6% versus 7.1% for those given lymphodepletion and Tecartus in the inpatient setting (28 patients). The six-month progression-free survival (PFS) rate was 83.3% for the outpatient group versus 71.1% for the inpatient group.

“[Tecartus] is safe to administer [in the outpatient setting] with similar efficacy and non-relapse mortality,” lead study author Dr. Tamer Othman of City of Hope in Durante, California, and colleagues wrote in a poster presentation of the data. “Future studies with [a] larger sample size and longer follow-up are needed to confirm our findings.”

Investigators conducted a retrospective study of adult patients with B-ALL or MCL treated with Tecartus at City of Hope between Nov. 1, 2020, and March 31, 2024. Patients were divided into two groups. The first group included patients given lymphodepletion in the outpatient setting, irrespective of the setting of Tecartus infusion. The second group featured patients given lymphodepletion in the inpatient setting.

In the overall population (56 patients), 66% had B-ALL, and 34% had MCL. The median age was 55 years, and most patients were male (77%), were Hispanic White (61%), had an ECOG performance status of 0 to 1 (93%), and had higher disease burden (75%). Patients received a median of four prior lines of therapy; 23% of patients underwent a prior allogeneic stem cell transplant and 7.1% received a prior autologous stem cell transplant.

In the outpatient group, 82% of patients received Tecartus in the outpatient setting; all patients in the inpatient group were infused with CAR-T cell therapy in the inpatient setting. Notably, 86% of patients in the outpatient group were admitted to the hospital after starting lymphodepletion in the outpatient setting at a median of eight days after the start of lymphodepletion. Reasons for admission included Tecartus-related toxicities such as fever because of cytokine release syndrome (CRS) (71%), hypotension due to poor oral intake (4.2%) and dyspnea (4.2%). Other reasons for admission included high-burden disease (13%), fever during lymphodepletion due to leukemia (4.2%) and pain control during lymphodepletion (4.2%). The median time hospitalized during the first 100 days from the start of lymphodepletion was 10 days in the outpatient group versus 27 days in the inpatient group.

Additional data showed that patients with B-ALL in the outpatient group (20 patients) achieved a complete response (CR) rate of 90% versus 88% in the inpatient group (17 patients). In patients with MCL, the CR rates were 75% in the outpatient group (eight patients) versus 73% in the inpatient group (11 patients).

Safety data showed that any grade CRS occurred in 86% of patients in the outpatient group versus 82% in the inpatient group. The rates of grade 3 (severe) or higher CRS were 7.1% and 14%, respectively. The respective median durations of CRS were four days and four days. Any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 54% of patients in the outpatient group versus 61% in the inpatient group. The respective rates of grade 3 or higher ICANS were 29% and 25%. The median duration of ICANS was four days in the outpatient group versus seven days in the inpatient group. Actemra (tocilizumab) was given for toxicity to 79% of patients in the outpatient group versus 75% of patients in the inpatient group. The median number of Actemra doses was two in both groups.

Steroids were given for toxicity to 79% of patients in the outpatient group versus 71% of patients in the inpatient group; the rates of prophylactic dexamethasone administration were 32% and 25%, respectively. Prophylactic anakinra was given to 29% of patients in the outpatient group versus 7.1% of those in the inpatient group. Treatment anakinra was given to 25% and 18% of patients, respectively.

“Outpatient administration of brexucabtagene autoleucel (brexu-cel) for acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL) is safe and feasible” by Dr. Tamer Othman et al., 

Outpatient lymphodepletion followed by Tecartus was found to be safe and effective in treating B-cell acute lymphoblastic leukemia and mantle cell lymphoma.

Canonical

Conference

Tecartus After Outpatient Lymphodepletion Safe, Effective in B-ALL and MCL

In recent years we have witnessed substantial progress in basic biomedical research and subsequent clinical management of WM. IWMF funded research has been so successful in making these advances in part because of its rigorous requirements for awarding grants, which includes a review by an independent committee composed of selected members of the IWMF Scientific Advisory Committee and other experts in the field. The IWMF Board of Trustees also must approve the research grants to be funded, and oversight by IWMF continues after the grants are awarded. Researchers who receive grant awards are required to submit periodic progress reports to the IWMF Research Committee for review and comment.

WM funded research should be guided by the pillars listed below.

 Includes research into signaling pathways driving the growth and survival of WM. Also includes are preclinical testing of novel therapeutic strategies and research into signaling mechanisms related to recurrent somatic mutations such as MYD88, CXCR4 and ARID1A as well as WM specific dysregulation of novel and established pathways such NF-kB, ERK, and PI3K/AKT.

 Includes development and preclinical testing of CAR-T and bi- and tri-specific antibodies, as well as the development of novel therapeutic strategies that promote immune anti-WM engagement. Also includes proposals to overcome T-cell anergy and counter the immunosuppressive effects associated with myeloid derived suppressor cells and similar mechanisms.

 Like many indolent lymphomas, WM cannot survive without the support of its local environment. This pillar supports research into identifying these dependencies and assessing their therapeutic potential. It also supports the development of organoids and xenograft models that can support long-term primary WM cultures for research and testing. This includes changes in microenvironmental composition, signaling, and spatial relationships associated with disease progression and response. In addition to T-cell exhaustion and immune dysregulation studies from the previous pillar, it also supports the development of organoids and xenograft models that can support long term primary WM cultures for research and testing.

Genomic, Epigenomic, and Transcriptional Research:

 Supports bulk, single cell, and spatial studies to better understand the biology of WM evolution from MGUS to symptomatic disease, as well as mechanisms driving primary and acquired therapeutic resistance. This pillar further supports related research into identification of high-risk features, novel target identification, and biological characterization of WM disease manifestations such as Bing Neel Syndrome and transformation.

 This pillar is distinct from the previous one as it focuses on protein properties and modifications that impact key WM signaling pathways or can be used for prognostic testing in a manner distinct from the underlying genetics. It also supports protein-based research into the causes and treatment of cryoglobulinemia, cold agglutinins, amyloid, demyelinating neuropathy, and other complications associated with the IgM paraprotein.

IWMF is currently accepting research proposals until February 26, 2025. To learn about IWMF Research Grant Opportunities, please see our webpage here: 

https://iwmf.com/applying-for-a-research-grant/

_______________________________________________________Social Media:Facebook: @waldenstroms.supportInstagram: @wmiwmfX: @WMIWMFLinkedIn: @international-waldenstroms-macroglobulinemia-foundation

2025 IWMF Request for Research Proposals

Topic: December 2024 - COA Patient Advocacy Network News Bulletin

Advocacy Chats - Educational Conversations on Cancer Policy and Advocacy Issues

Be sure to catch up on all Advocacy Chat sessions about health equity, 

visits, pharmacy benefit managers, 2024 Advocacy Highlights, and more. 

 COA director of patient advocacy and education, and guests explore ways for advocates to advance cancer care. 

Stream past chats on @OncologyCOA's YouTube channel

Empower & Advocate: Save the Date for the 2025 Community Oncology Conference

When community oncology comes together, it creates a stronger future for independent cancer care. Don’t miss the 

, Apr. 29-30 in Orlando, Fla., where advocates, community oncology professionals, and other stakeholders convene to learn from and connect with peers. 

Save the date for the 2025 Community Oncology Conference

Watch Angelina's Advocacy in Action Story [60 Seconds]

“Community oncology stands up for what patients deserve,” says CPAN advocate Angelina. Watch the latest 

 to learn how she strengthened connections with policymakers by sharing her personal story and pushing for policies that support high-quality, personalized cancer care.

Why Doctors Think Colon Cancer Is On The Rise In Gen Z And Millennials

Consuming large amounts of ultra-processed foods raises the risk of several types of cancer, including colorectal, breast, and pancreatic cancers, according to research published in the 

. While specific causes are unknown, some researchers say that lifestyle changes among young people can help reduce the risk of colon cancer. "We know that high fiber diets can help reduce risk for colorectal cancer but unfortunately the American diet is typically low in fiber," said Dr. Anne K. Mongiu, a colon and rectal surgeon in New Haven, Conn.

Global Cancer Disparities To Grow By 2050: Study

Cancer cases and deaths will increase most in low- and middle-income countries that may have less access to health care or face competing priorities for allocating resources. Cases are projected to grow by nearly 77% from 2022 to 2050 and reach 35.3 million worldwide, according to research published in 

. Death rates will rise 146% in low-income countries, while high-income countries will see a roughly 91% increase and very-high income countries, including the United States, will see a nearly 57% growth.

Lung Cancer On The Rise In U.S. Asian Women Who Don't Smoke. Experts Hope To Expand Screenings.

Of the Asian women diagnosed with lung cancer, 57% are nonsmokers, according to a study by leading Calif. medical centers. For all others, only 15% of women diagnosed had no history of smoking. People who don’t smoke aren’t eligible to get screened for lung cancer. "Currently, 

 drive what's covered under insurance," said study researcher Scarlett Gomez, epidemiologist of University of California San Francisco.

Help federal and state policymakers understand the value of independent community oncology by hosting a 

. With many state lawmakers out of session through early 2025, use your 

December 2024 - COA Patient Advocacy Network News Bulletin

It is an honor to nominate Denise Hauser, RN, BSN, OCN, for the 2024 CURE Extraordinary Healer Award. For more than35 years of Denise’s nursing career, she has touched thousands of lives including her patients, their lovedones and her colleagues. Each person Denise encounters is left feeling important and valued after interacting with her.

It is impossible to choose which area she excels in best: extraordinary expertise, compassion and helpfulness. She is equally outstanding in each domain, as you will read. Denise’s oncology career has spanned multiple states and multiple settings: inpatient bedside nursing, infusion nursing and the last stop on her journey is in the outpatient nurse navigation setting.

Before receiving her BSN, Denise worked in social work, which has served her well over these years as she continually focuses on the “big picture” and seeks to care for the mind, body and spirit of her patients. She has curated her own professional career by combining the roles of nurse, social worker, mentor, friend, wife and mom into one beautiful and selfless cheerleader for all who cross her path. Countless peers will tell you that Denise “goes above and beyond for her patients and her colleagues.”

The majority of her career has been spent caring for the hematology, oncology and stem cell transplant patients at our hospital and she, in many ways, has become the face of nursing within our cancer center. A patient needs to see hematology today? Call Denise. A patient has some “weird labs?” Call Denise. How can we schedule multiple diagnostic tests on the same day and squeeze in a treatment? Call Denise. The answer is always to call Denise. She uses her incredible understanding of the disease processes and kind spirit to help her patients navigate a very difficult time in their lives.

Denise shines brightest when it comes to patient education and advocacy. Having maintained her oncology nursing certification (OCN) for more than 20 years, Denise has remained dedicated to the highest standards and has raised the bar in patient education within our cancer center. She is an active member of the Chicago Chapter Oncology Nursing Society and attends as many learning events as possible. She takes the time to listen, learn and network with peers and educators on her quest to acquire patient resources. She comes back from these events with stacks of booklets, handouts and pocket guides to stockpile her library of materials in several languages and she freely shares them with everyone. She frequently references The Leukemia & Lymphoma Society, Imerman Angels and American Cancer Society materials to provide evidence-based information to our patients and their caregivers. Despite her longevity in oncology nursing, Denise hasremained hungry for up-to-date, best practice learning opportunities and activelydisseminates what she learns andacquires in a meaningful way to our patients.

Additionally, she reflects on her own experiences in nursing, what she humorously calls “the good, the bad and the ugly,” to bring real world, personal stories to aid patients as they go through their personal journeys.

Of all the nurse navigators on our team, Denise spends the most time providing education sessions with patients and caregivers prior to starting treatment. She does this in person or over the phone and will remain with the patient until each and every question is answered, which can sometimes take two or more hours. She touches on sensitive topics, drives home important points for patient safety and reminds patients that she is always available for them. Denise is a major proponent of “doing what is right for the patient” for the continuum of their care, regardless of whether that is two months or two decades.

Denise's commitment extends beyond the call of duty; she is often one of the last nurses on campus, tirelessly caring for patients and addressing the myriad messages her team receives. She is never one to question if it is within her scope to ask a respectfully question a provider, challenge leadership or voice a concern. Rather, she feels it is her obligation and ethical duty to the patient to advocate for them, even if it means working late several nights per week. She takes time out of her day to speak with outside institutions caring for mutual patients to make sure those clinics are also aware of the plan of care so that all needs can be coordinated safely and efficiently.

A recent example of her dedication comes from a pharmacist on our team who recounts that it was Denise who noticed a patient’s platelet count skyrocketed after initiation of therapy based on labs from an outside hospital. Denise immediatelygot in touch with the pharmacy and her attending physician to sound the alarm, discuss management and was on the phone with the patient numerous times during this after-hours incident to educate and provide reassurance. Denise's quick follow-up helped this patient avoid serious side effects, and her willingness to put patients first no matter the time of day proves how much of a caring individual she is. This is one of hundreds of examples to highlight her care, concern and healing nature throughout her career.

Her advocacy to foster healing within each patient she meets goes beyond the clinic setting. Denise has a robust commitment to volunteer service and nurse empowerment. During the chaos of the COVID-19 pandemic, Denise volunteered dozens of hours at our hospital’s vaccination clinic, always after hours and also on weekends. She has served as captain of the Rush University team for The Leukemia & Lymphoma Society’s annual Light the Night fundraiser and walk. This year, she helped host bake sales and off-campus events to increase donations. Each year, she spearheads gift basket committees and invites patients and caregivers to the Rush University Cancer Survivors’ Day. Every summer, she volunteers her time at the Lymphoma Research Foundation walk and receiveda special recognition for her years of outstanding service. She is also the unofficial team photographer, capturing precious moments and interactions between patients and our team. At each volunteer event, Denise brings patients, survivors, caregivers and peers together to celebrate the victories and cherish those lost.

On numerous occasions, Denise has run into patients and caregivers who recognize her outside of work. One of the best stories is from when a patient recognized her on a lake from a moving boat several yards away. The patient was so thrilled to see Denise and yelled to her, “Denise! I’m your patient! Remember me? You gave me my chemo all those years back and I’m doing great!” Those who know Denise can attest that there are so many patients who have shared similar experiences with Denise. The long-term relationships that Denise has with these patients are equally important to Denise as they are for her patients.

As Denise winds down her professional career, she is steadfast in that she wants her advocacy for and impact on her fellow nurses to be her legacy. Her expertise as an oncology nurse is unparalleled; offering invaluable insights and guidance to those fortunate enough to work alongside her and to be mentored by her. Her infectious positivity, personality and pleasant demeanor create an uplifting atmosphere that lingers long after her shifts. Denise takes her unofficial role as “work mom” to heart and always offers a listening ear devoid of judgment and willing to talk through a problem. She welcomes new ideas, fosters relationships with younger nurses and encourages us all to grow professionally as much as possible.

She has worn many hats as a nursing advocate serving as co-chairperson for our unit advisory committee, which serves as a safe space for nurses to discuss concerns and work together for solutions. She has been invited to take part in rapid improvement projects related to the nurse navigation role and has been a key member in our unit based oral oncolytic workflow project, which has produced positive outcomes in patient safety since its inception.

It is because of her selflessness and commitment to nursing that she has carved out a lasting impact on generations of nurses after her, who will be charged with picking up the baton of caregiver and healer now and in future generations. In a career that is widely known for burnout, Denise is an outlier who has continued to rise above and find the beautiful moments in nursing. Her goal in becoming a nurse and focusing on hematology/oncology was never to receive recognition; she just wanted to make a positive impact on patients’ lives. In doing all the wonderful things she has done and touching so many lives in a way that is uniquely Denise, she has made those who work with her better nurses, and she has healed the hearts and minds of thousands of patients and caregivers along the way.

Denise is undeniably deserving of recognition for her outstanding contributions and unwavering dedication to nursing excellence and the pursuit of patient care, empowerment, and healing.

Oncology nurse Denise always makes it a point to focus on the “big picture” for all of her patients with cancer.  

An Extraordinary Healer Inside and Out 

Among patients with advanced gastric cancer, pre- and postsurgical treatment with the anti-PD-1 antibody camrelizumab and a low dose of the VEGFR-2 inhibitor rivoceranib plus the chemotherapies S-1 and oxaliplatin (SOX), a combination known as SOXRC, has been shown to elicit superior responses compared to SOX alone, researchers have found.

Findings from the phase 3 DRAGON IV/CAP 05 study of patients with locally advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma were published in the 

Patients with locally advanced gastric cancers saw complete response rates of 18.3% from camrelizumab and rivoceranib plus chemotherapy.

A. Mark Fendrick & Dan Klein

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