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Marlee Matlin, an Academy award-winning actress, discusses her father’s diagnosis and journey with multiple myeloma.

Marlee Matlin Discusses Her Father's Diagnosis of Multiple Myeloma

Former U.S. president Jimmy Carter — who served as the country’s commander in chief from 1977 to 1981 — died at 100 years old, making him the longest-living president in American history.

“My father was a hero, not only to me but to everyone who believes in peace, human rights and unselfish love,” Chip Carter, Jimmy Carter’s son, said in a statement on his death from the Carter Center. “My brothers, sister and I shared him with the rest of the world through these common beliefs. The world is our family because of the way he brought people together, and we thank you for honoring his memory by continuing to live these shared beliefs.”

Carter’s care put a spotlight on the immunotherapy drug, Keytruda (pembrolizumab), which was approved 11 months before his diagnosis of metastatic melanoma in August 2015. After receiving surgery for a mass on his liver and then radiation to treat the brain metastases, Carter went on to receive Keytruda, a monoclonal antibody that works by helping the immune system find and fight cancer.

In December 2015, the former president announced that there were no signs of the original cancer, nor any signs of new ones on a brain MRI. In an August 2016 interview with NBC News, Carter said, “A year ago, I didn’t think I was going to live for two or three weeks. … I was putting on kind of a false, optimistic face.”

In Recent Decades, Immunotherapy Extended Advanced Melanoma Survival from Months to Years

In a story posted on NBC News, Dr. Suresh Ramalingam, executive director of the Winship Cancer Institute of Emory University, where Carter was treated at the time, noted that he and his colleagues were “immensely grateful” for his efforts in raising awareness around immunotherapy.

“When we see patients like President Carter beat their cancer, that is the positive reinforcement that drives us to do even better,” Ramalingam said.

In February 2023, Carter opted to undergo hospice care, a service for individuals who are at the end of their life, with the goal of providing comfort, reducing pain and addressing physical and psychological needs for both patients and providers. Carter’s wife, Rosalynn Carter, who had dementia, also entered hospice care in November 2023, before her death on Nov. 19.

The Carter Center, a nonprofit established by the former president and his wife, Rosalynn, announced on Feb. 18, 2023, “After a series of short hospital stays, former US President Jimmy Carter today decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention. He has the full support of his family and his medical team.”

Many people across social media and via public comments have made statements on Carter’s death.

“With his compassion and moral clarity, he worked to eradicate disease, forge peace, advance civil rights and human rights, promote free and fair elections, house the homeless and always advocate for the least among us,” President Joe Biden and First Lady Jill Biden said in a joint statement. “He saved, lifted and changed the lives of people all across the globe.”

President-elect Donald Trump also commented on Truth Social by writing, “The challenges Jimmy faced as president came at a pivotal time for our country, and he did everything in his power to improve the lives of all Americans. For that, we all owe him a debt of gratitude.”

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

Jimmy Carter, the longest-living U.S. president, passed away at 100. His battle with metastatic melanoma highlighted the effectiveness of Keytruda, an immunotherapy drug. After treatment, Carter announced cancer remission in 2015. His case raised awareness about immunotherapy's potential in cancer treatment. In 2023, Carter chose hospice care, focusing on comfort in his final days. His death prompted tributes from global leaders, acknowledging his contributions to peace, human rights, and healthcare. The Carter Center continues his legacy of humanitarian efforts and advocacy for the underserved.

Former U.S. President Jimmy Carter called attention to the immunotherapy drug Keytruda, which was used to successfully treat his cancer. 

Tumor

Former U.S. President Jimmy Carter Dies at 100

Throughout December, the Food and Drug Administration (FDA) approved several oncology drugs for the treatment of cancers including pancreatic, lung and skin.

Here is a select list of cancer therapies approved by the FDA last month.

Bizengri for Some with NSCLC, Pancreatic Adenocarcinoma

 (zenocutuzumab-zbco), the first systemic therapy for patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose tumors have a NRG1 gene fusion and have progressed after prior systemic therapy. This accelerated approval applies to both NSCLC and pancreatic adenocarcinoma.

The eNRGy study evaluated Bizengri's effectiveness in 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma whose disease had progressed after standard treatment. In the NSCLC group, the objective response rate (ORR) was 33%, with a median duration of response (DOR) of 7.4 months. The pancreatic adenocarcinoma group had a 40% ORR, with a DOR ranging from 3.7 to 16.6 months.

Imfinzi for Limited-Stage Small Cell Lung Cancer

 (durvalumab) was approved for adults with limited-stage small cell lung cancer who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation therapy.

The ADRIATIC trial showed that Imfinzi significantly improved both overall survival and progression-free survival (PFS) compared to placebo. Median overall survival was 55.9 months for patients receiving Imfinzi versus 33.4 months for those receiving placebo. Similarly, median PFS was 16.6 months with Imfinzi compared to 9.2 months with placebo.

Unloxcyt for Locally Advanced, Metastatic Skin Cancer Subset

The FDA granted approval to Unloxcyt (cosibelimab-ipdl) for the treatment of patients with locally advanced or metastatic cutaneous 

 (a type of skin cancer) who are not candidates for curative surgery or radiation. Unloxcyt is a PD-L1-blocking antibody, a type of immune checkpoint inhibitor that helps the body's immune system target and destroy cancer cells.

In a clinical trial, researchers assessed the ORR and DOR to the treatment. The ORR was 47% in 78 patients with metastatic cutaneous squamous cell carcinoma and 48% in 31 patients with locally advanced disease. The median DOR was not reached in the metastatic group, indicating that the response was durable, and most patients had not experienced disease progression at the time of data analysis. Among those with locally advanced disease, the median DOR was 17.7 months.

The FDA has approved Ensacove (ensartinib) for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic NSCLC. This approval is specifically for patients who have not previously received an 

 demonstrated that Ensacove significantly improved PFS compared to Xalkori. The median PFS with Ensacove was 25.8 months, more than double the 12.7 months observed with Xalkori.

Ryoncil Receives FDA Approval for Children With GVHD

 (remestemcel-L-rknd) was approved for children aged two months and older with steroid-refractory acute graft-versus-host disease. This is the first mesenchymal stromal cell therapy to receive FDA approval.

By day 28 of the study, the overall response rate reached 70%, with 30% of patients achieving a complete response and 41% achieving a partial response. The median DOR was 54 days, with responses lasting from seven days to at least 159 days.

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

subscribe to CURE®’s newsletters here.

The FDA recently approved several oncology drugs, including Bizengri for NRG1 fusion-positive NSCLC and pancreatic adenocarcinoma, Imfinzi for limited-stage small cell lung cancer, Unloxcyt for advanced cutaneous squamous cell carcinoma, Ensacove for ALK-positive NSCLC, and Ryoncil for pediatric steroid-refractory acute GVHD. These approvals highlight significant advancements in targeted therapies and immunotherapies, offering improved outcomes in terms of objective response rates, progression-free survival, and overall survival across various cancer types. These developments underscore the ongoing progress in personalized cancer treatment strategies.

The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease.

Cancer Therapies Approved by the FDA in December 2024

Polycythemia Vera: Overview

Video content above is prompted by the following:

How is PV similar/different compared with other MPNs?

Who is at risk for PV (age, gender, genetic factors)?

A panelist discusses how polycythemia vera (PV) is a rare myeloproliferative neoplasm (MPN) characterized by excessive red blood cell production, primarily affecting older adults with JAK2 mutations, and while it can be managed with treatment, patients face increased risks of blood clots and potential progression to more serious conditions.

Video Series

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.

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

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

Marlee Matlin

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