Episodes

  • S1 Ep120: Improving CAR T-Cell Therapy Monitoring Strategies and Access in Lymphoma

    S1 Ep120: Improving CAR T-Cell Therapy Monitoring Strategies and Access in Lymphoma
    Jul 29 2024
    In a conversation with CancerNetwork®, Nausheen Ahmed, MD, spoke about optimizing monitoring strategies for patients with B-cell non-Hodgkin lymphoma who undergo treatment with CAR T-cell therapy.


    Ahmed, an associate professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, discussed the possibility of offering more flexible monitoring periods for patients in the context of findings from a real-world study published in Blood Advances.1 Data from her study showed that the occurrence of new onset cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) was rare at more than 2 weeks following CAR T-cell therapy infusion. Additionally, late non-relapse mortality generally resulted from infectious complications.


    The FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) to help manage the risk of severe CRS and ICANS by requiring patients to reside within 2 hours of an authorized treatment center for 4 weeks following CAR T-cell therapy infusion.2 According to the study authors, this mitigation strategy may create significant barriers to CAR T-cell therapy access among certain patients and caregivers who need to relocate as part of a treatment plan.


    Findings from Ahmed’s study supported the development of individualized monitoring strategies depending on the stability of the patient. She and her coauthors proposed a 2-week monitoring period for patients while allowing for an optional increase to 4 weeks based on factors such as physician comfort and availability of local community oncology support. As Ahmed emphasized during the discussion, having flexibility in these monitoring periods could help mitigate financial and geographic obstacles preventing adequate access to CAR T-cell therapy among patients.


    “There has to be more of a hybrid model of care. There has to be more involvement of our referring doctors or community doctors in detecting and managing these infections or working with the specialized center in order to bypass the [emergency room] and other strategies to help these patients,” Ahmed said. “If there is enough data to say that the patients do not need extra restrictions beyond 2 weeks, which is what our studies show, then reconsidering the requirements will be one step towards decreasing disparities in access.”


    References


    1. Ahmed N, Wesson W, Lutfi F, et al. Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. Blood Advances. Published online July 24, 2024. doi:10.1182/bloodadvances.2023012549

    2. Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies modified to minimize burden on healthcare delivery system. FDA. June 26, 2024. Accessed July 23, 2024. https://tinyurl.com/2m284rjy
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    16 mins
  • S1 Ep119: Exploring New Possibilities in Kidney Cancer Detection and Therapy

    S1 Ep119: Exploring New Possibilities in Kidney Cancer Detection and Therapy
    Jul 22 2024
    At the 2024 Kidney Cancer Research Summit (KCRS), CancerNetwork® spoke with various experts in the kidney cancer field about potential advancements in disease detection and updated efficacy data on immunotherapy and other treatment strategies in patients with renal cell carcinoma (RCC).


    Karl Semaan, MD, MSc, a postdoctoral oncology research fellow at Dana-Farber Cancer Institute, discussed the implications of findings related to the use of an investigational tissue-informed liquid biopsy epigenomic profiling tool for detecting sarcomatoid differentiation in RCC.1 According to Semaan, this method may avoid the sampling errors and spatial heterogeneity challenges associated with traditional biopsy strategies.


    Additionally, Neil J. Shah, MBBS, an assistant attending physician from Memorial Sloan Kettering Cancer Center, spoke about data from a real-world study evaluating treatment patterns and outcomes in those with metastatic RCC following prior receipt of immunotherapy and tyrosine kinase inhibitors (TKIs).2 Data showed no differences in overall survival (OS) outcomes across different immunotherapy- and TKI-containing regimens. Based on these findings, Shah emphasized a need for additional novel therapeutic approaches to help improve outcomes in later-line settings of treatment.


    Bradley A. McGregor, MD, director of Clinical Research for the Lank Center of Genitourinary Oncology and medical oncologist specializing in genitourinary malignancies at Dana-Farber Cancer Institute, highlighted findings from his presentation on a phase 1b study (NCT04627064) evaluating treatment with abemaciclib (Verzenio) in a pretreated metastatic clear cell RCC population.3 Among 11 patients who received abemaciclib, 1 had stable disease, 8 had progressive disease, and 2 were not evaluable for response. Additionally, the median progression-free survival (PFS) and overall survival (OS), respectively, was 1.8 months (95% CI, 1.5-1.9) and 9.1 months (95% CI, 2.1-15.3).


    Although abemaciclib monotherapy yielded no responses in the study, McGregor highlighted the potential clinical utility of administering the agent in combination with other therapies. Findings from his presentation suggested that CDK4/6 inhibitors may demonstrate a synergistic effect when combined with HIF-2α inhibitors, which is a potential strategy that investigators are evaluating with belzutifan (Welireg) and palbociclib (Ibrance) combination therapy as part of the phase 1/2 LITESPARK-024 trial (NCT05468697).



    References


    1. Semaan K, Zarif TE, Eid M, et al. Liquid biopsy epigenomic profiling for the detection of sarcomatoid renal cell carcinoma. Presented at the 2024 Kidney Cancer Research Summit; July 11-12, 2023; Boston, MA. Abstract 44.

    2. Shah N, Sura S, Shinde R, et al. Real-world treatment patterns and clinical outcomes of metastatic renal cell carcinoma patients post immune-oncology (IO) and Vascular Endothelial Growth Factor (VEGF) receptor targeted therapies. Presented at the 2024 Kidney Cancer Research Summit; July 11-12, 2023; Boston, MA. Abstract 36.

    3. McGregor BA, Xie W, Xu W, et al. Phase IB trial of abemaciclib in advanced renal cell carcinoma. Presented at: 2024 Kidney Cancer Research Summit; July 11-12, 2024. Boston, MA.
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    10 mins
  • S1 Ep118: Overcoming Physical and Social Barriers in the Lymphoma Field

    S1 Ep118: Overcoming Physical and Social Barriers in the Lymphoma Field
    Jul 15 2024
    As part of the Breaking Barriers: Women in Oncology program, CancerNetwork® spoke with Julie M. Vose, MD, MBA, and Avyakta Kallam, MD, about the evolution of their careers in the hematology-oncology space, including some of the critical advances and challenges associated with their work in the lymphoma field.


    Vose is division chief, Neumann M. and Mildred E. Harris Professor at the University of Nebraska Medical Center, and co-editor-in-chief of ONCOLOGY®. Kallam is an assistant professor in the Division of Lymphoma and Department of Hematology & Hematopoietic Cell Transplantation from City of Hope in Duarte, California.


    Vose and Kallam discussed how they first developed a passion for researching lymphoma, which led them to become involved in various breakthroughs related to the use of treatment strategies such as autologous stem cell transplantation, bispecific antibodies, and CAR T-cell therapy. The conversation highlighted how this evolution of therapy options has helped improve patient outcomes while reducing hospitalization periods and minimizing toxicity.


    The discussion also extended to the topic of overcoming various physical and social barriers while trying to advance in the lymphoma field. For example, Kallam described her experience with moving to the United States from India to complete her medical training, which involved adapting to a new culture and a new style of approaching treatment.


    In the early stages of Vose’s career, there were far fewer women involved in oncology and medicine in general, contributing to the challenge of needing to work extremely hard to prove that she was equal to her male colleagues. Vose noted in the early days, she was considered a rarity in the field as one of very few women.


    Vose and Kallam also brought up how their mentors have given them key pieces of advice from mentors that have stuck with them throughout their careers. They, in turn, offered wisdom to any woman looking to advance in the hematology-oncology space.


    “The biggest piece of advice [I received] is to see the patient as a person—not just as a patient—to be able to get to know them and their families understand some of their struggles so that you can relate to them as a person,” Vose said.


    The conversation also focused on the challenge of achieving work/life balance while making advances in the lymphoma space. Dedicating time to hobbies and finding support from friends and family members emerged as potential strategies for balancing professional responsibilities with one’s personal life.


    “Life is too unpredictable to not do things that you enjoy doing,” Kallam said, recounting a bit of advice she had received from one of her mentors. “What we’re doing is important; we are impacting lives. We’re doing a lot of research, but at the same time, keep in mind to have fun along the way.”
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    19 mins
  • S1 Ep117: Epcoritamab Approval Expands Bispecific Use in Follicular Lymphoma

    S1 Ep117: Epcoritamab Approval Expands Bispecific Use in Follicular Lymphoma
    Jul 8 2024
    Tycel Phillips, MD, spoke with CancerNetwork® ahead of the FDA’s accelerated approval of epcoritamab-bysp (Epkinly) for patients with relapsed/refractory follicular lymphoma to discuss how this agent may impact the treatment paradigm.


    Phillips, an associate professor in the Division of Lymphoma and Department of Hematology & Hematopoietic Stem Cell Transplantation at City of Hope in Duarte, California, reviewed data from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), which ultimately supported the approval of epcoritamab in the aforementioned population. Topline results reported at the time of the agent’s approval showed an overall response rate (ORR) of 82% (95% CI, 74.1%-88.2%), with 60% of patients experiencing a complete response. Additionally, the median duration of response was not reached (NR; 95% CI, 13.7-NR).


    Beyond the supporting data, Phillips highlighted how this approval may increase availability of treatment options for patients with follicular lymphoma, especially those who lack access to alternative therapies. He stated that readily available off-the-shelf bispecific antibodies like epcoritamab may bridge the gap for patients who are unable to access CAR T-cell therapies or travel to a major academic center for treatment.


    Phillips also detailed strategies for mitigating some of the common toxicities that may occur following treatment with epcoritamab, which include cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. Although Phillips said that epcoritamab is usable in the third-line setting, he noted that bispecific antibodies like it “have a lot of potential for upward mobility,” as he anticipates further assessment of these treatments in the first or second line.


    “As community oncologists get more and more comfortable with these drugs and have the structure to set up to safely administer [them] for the first month when most of the complications happen, more and more patients will be able to be treated, which will be a great benefit based on what we’ve seen in early response rates for these drugs,” Phillips said regarding the utility of bispecific antibodies like epcoritamab. “There’ll be a big benefit for the patient population in the long term as more community settings implement these drugs into their clinical practice.”


    Reference


    FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. News release. FDA. June 26, 2024. Accessed June 26, 2024. https://tinyurl.com/26s9myey
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    13 mins
  • S1 Ep116: Leveraging Artificial Intelligence Evolutions in Prostate Cancer Care

    S1 Ep116: Leveraging Artificial Intelligence Evolutions in Prostate Cancer Care
    Jul 1 2024
    In a conversation with CancerNetwork®, James B. Yu, MD, MHS, FASTRO, and Julian C. Hong, MD, MS, spoke about their study titled AI Use in Prostate Cancer: Potential Improvements in Treatments and Patient Care, which was published in the May issue of the journal ONCOLOGY®.


    Yu is a radiation oncologist in the Department of Radiation Oncology at Smilow Cancer Center Hospital at Saint Francis Hospital and an adjunct assistant professor of Medical Oncology at Yale School of Medicine. Hong is an assistant professor in the Department of Radiation Oncology of Bakar Computational Health Sciences Institute at the University of California, San Francisco (UCSF).


    Yu and Hong focused on the growing overlap between the advancement of artificial intelligence (AI)–based tools and the prostate cancer treatment field. In their study, they detailed AI-based developments related to diagnostic image analysis, the ability to “predict” prostate cancer outcomes, evaluating prostate cancer histopathology, and defining tumors and normal tissue to help plan radiation oncology treatment strategies. Additionally, they reviewed how these tools make use of machine learning algorithms, a subset of AI in which computers can assess data and interact with users without explicit instructions.


    “We’re trying to incorporate AI and machine learning into more trials to make these types of predictions because, at the end of the day, we’re trying to deliver better care and improve outcomes for patients…. It takes trials to figure those things out, so it’s a little bit of a work in progress.” Hong said, regarding potential next steps for improving the utility of these tools in the prostate cancer field.


    According to the authors, pushing the boundaries of AI would need to involve building upon prior retrospective data with additional sources of information to affirm that such tools can impact patient care. Additionally, the discussion highlighted potential future implications related to data ownership or privacy and how patients and physicians interact with these programs as AI becomes more prevalent in medical practice.


    “We’re not going to be replaced [by AI]. There will always be the need for the human connection any time there’s disease or cancer,” Yu said. “It’s a super exciting area, and the more people understand the limitations of AI rather than thinking of it as a panacea, the more the field will move forward.”
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    32 mins
  • S1 Ep115: Ensuring Quality Outcomes in Hematologic Cancer Subgroups at EHA 2024

    S1 Ep115: Ensuring Quality Outcomes in Hematologic Cancer Subgroups at EHA 2024
    Jun 24 2024
    At the 2024 European Hematology Association (EHA) Congress, CancerNetwork® spoke with a variety of experts in the hematologic oncology space about optimizing outcomes across different patient populations and subgroups based on updated research they presented at the meeting.


    Manali Kamdar, MD, an associate professor of medicine-hematology and clinical director of Lymphoma Services at the University of Colorado Anschutz Medical Campus, in Colorado, spoke about data from the phase 1 TRANSCEND NHL 001 trial (NCT02631044) supporting the use of lisocabtagene maraleucel (liso-cel; Breyanzi) in earlier lines of therapy for patients with relapsed/refractory mantle cell lymphoma (MCL).1


    Specifically, Kamdar highlighted how research should continue to focus on the potential utility of liso-cel in MCL subgroups such as those with TP53 mutations or blastoid morphology. Additionally, she stated that liso-cel may need to be further tested in earlier lines of therapy for patients with diffuse large B-cell lymphoma, including those with double-hit lymphoma.


    Michael R. Grunwald, MD, chief of the Leukemia Division and director of the Transplantation and Cellular Therapy Program at Atrium Health’s Levine Cancer Institute, in North Carolina, discussed findings from the Prospective Observational Study of Patients With Polycythemia Vera (PV) in US Clinical Practices Trial (REVEAL) exploring risk factors for disease progression in patients with polycythemia vera (PV).2


    According to Grunwald, a history of thromboembolic events, elevated white blood cell counts, and higher variant allele frequencies may contribute to a patient’s likelihood of experiencing progression to myelofibrosis or acute myeloid leukemia (AML). Additionally, he highlighted ongoing research into the potential molecular factors that may prognosticate disease transformation in PV among a small cohort of patients enrolled on the REVEAL trial.3


    Harry P. Erba, MD, PhD, a professor of medicine in the Division of Hematologic Malignancies and Cellular Therapy and the director of the Leukemia Program and Phase I Development in Hematologic Malignancies at Duke Cancer Institute, in North Carolina, discussed the clinical implications of data from the phase 3 QuANTUM-First study (NCT02668653).4


    Specifically, findings demonstrated that continuation therapy with quizartinib (Vanflyta) elicited a more pronounced survival benefit vs placebo in patients with newly diagnosed FLT3-ITD–positive AML who did not undergo allogeneic hematopoietic stem cell transplant (allo-HSCT). However, Erba noted that survival outcomes were not significantly different in the quizartinib and placebo arms among patients who received allo-HSCT.


    References


    1. Palomba ML, Siddiqi T, Gordon LI, et al. Subgroup analyses in patients with R/R MCL treated with lisocabtagene maraleucel by prior lines of therapy and response to Bruton tyrosine kinase inhibitor from the TRANSCEND NHL 001 MCL cohort. Presented at the European Hematology Association (EHA) 2024 Congress; Madrid, Spain; June 13-16, 2024. P1126.

    2. Grunwald M, Zwicker J, Gerds A, et al. A real-world evaluation of risk factors for disease progression in patients with polycythemia vera (PV) enrolled in REVEAL. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract P1047.

    3. Crowgey E, Timmers C, Xue Z, et al. Analysis of molecular mechanisms and predictive biomarkers of disease transformation in polycythemia vera. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract S217.

    4. Sekeres MA, Erba H, Montesinos P, et al. QuANTUM-First: efficacy in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication–positive (FLT3-ITD+) acute myeloid leukemia (AML) who received continuation therapy. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract S142.
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    8 mins
  • S1 Ep114: Applying Updated Breast Cancer Findings From ASCO to Clinical Practice

    S1 Ep114: Applying Updated Breast Cancer Findings From ASCO to Clinical Practice
    Jun 17 2024
    Following the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Neil M. Iyengar, MD, and Paolo Tarantino, MD, co-hosted a live X Space with CancerNetwork® and discussed the latest trial updates that may impact clinical practice in the breast cancer field. Iyengar is an associate attending physician at Memorial Sloan Kettering Cancer Center and a co-editor-in-chief of ONCOLOGY®. Tarantino is a clinical research fellow at Dana-Farber Cancer Institute and Harvard Medical School. Iyengar and Tarantino discussed data regarding several trials and studies presented at the meeting. These presentations included: · Phase 3 DESTINY-Breast06 Trial (NCT04494425)1 o Investigators evaluated treatment with trastuzumab deruxtecan (T-DXd; Enhertu) compared with investigator’s choice of chemotherapy among patients with hormone receptor (HR)–positive, HER2-low or HER2-ultralow metastatic breast cancer. o The median progression-free survival (PFS) was 13.2 months with T-DXd compared with 8.1 months in patients who received chemotherapy across the HER2-low population (HR, 0.62; 95% CI, 0.51-0.74; P <.0001). o Primary analysis overall survival (OS) data show favorable trends in the T-DXd arm across the HER2-low group (HR, 0.83; 95% CI, 0.66-1.05; P = .1181) and the intent-to-treat (ITT) population (HR, 0.81; 95% CI, 0.65-1.00). However, the OS data only reached 40% maturity at the time of the analysis. · Phase 3 postMONARCH Study (NCT05169567)2 o Patients with HR-positive, HER2-negative breast cancer and disease progression on CDK4/6 inhibitors and endocrine therapy were assigned to receive abemaciclib (Verzenio) or matched placebo plus fulvestrant (Faslodex). o The median PFS per investigator assessment was 5.6 months (95% CI, 5.4-9.2) with abemaciclib-based therapy vs 3.9 months (95% CI, 3.7-5.4) with placebo plus fulvestrant (HR, 0.66; 95% CI, 0.48-0.91; P = .01). o The investigator-assessed objective response rate (ORR) was 17% vs 7% in each respective arm. · Phase 2 SACI-IO HR+ Trial (NCT04448886)3 o Investigators assessed sacituzumab govitecan-hziy (Trodelvy) alone or in combination with pembrolizumab (Keytruda) for HR-positive, HER2-negative metastatic breast cancer regardless of PD-L1 status. o Combination therapy yielded a numerical improvement in median PFS (8.12 months; 95% CI, 4.51-11.12) compared with sacituzumab govitecan monotherapy (6.22 months; 95% CI, 3.85-8.68), although this improvement did not reach statistical significance (HR, 0.81; 95% CI, 0.51-1.28; P = .37). o Immature OS data presented at the meeting highlighted a median OS of 18.52 months (95% CI, 16.55-not applicable [NA]) vs 17.96 months (95% CI, 12.50-NA) in each respective arm (HR, 0.65; 95% CI, 0.33-1.28; P = .21). References 1. Curigliano G, Hu X, Dent RA, et al. Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): primary results from DESTINY-Breast06 (DB-06). J Clin Oncol. 2024;42(suppl 17):LBA1000. doi:10.1200/JCO.2024.42.17_suppl.LBA1000 2. Kalinsky K, Bianchini G, Hamilton EP, et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: primary outcome of the phase 3 postMONARCH trial. J Clin Oncol. 2024;42(suppl 17):LBA1001. doi:10.1200/JCO.2024.42.17_suppl.LBA1001 3. Garrido-Castro A, Kim, SE, Desrosiers J, et al. SACI-IO HR+: a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. J Clin Oncol. 2024;42(suppl 17):LBA1004. doi:10.1200/JCO.2024.42.17_suppl.LBA1004
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    31 mins
  • S1 Ep113: Optimizing Metastatic CRC Outcomes Following Fruquintinib Approval

    S1 Ep113: Optimizing Metastatic CRC Outcomes Following Fruquintinib Approval
    Jun 10 2024
    In a conversation with CancerNetwork®, Jagoda Misniakiewicz, PharmD, a clinical pharmacy specialist in the Clinical Pharmacy and Outcomes Sciences Department at Hollings Cancer Center of the Medical University of South Carolina, spoke about the use of fruquintinib (Fruzaqla) as a treatment option for those with metastatic colorectal cancer (CRC).


    The FDA previously approved fruquintinib as a treatment for those with metastatic CRC and prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy in November 2023.1


    Misniakiewicz detailed the agent’s mechanism of action as a potent, orally available small molecule kinase inhibitor and its potential to inhibit blood vessel growth, thereby yielding vascular regression, normalization, and construction. Additionally, the clinical benefit of switching from intravenous therapy to this oral treatment appears to extend to any patient who has progressed on prior therapy, although she noted that there are currently no specific biomarkers or tumor characteristics that would make patients suitable candidates for fruquintinib.


    The discussion also focused on the efficacy and safety data supporting the clinical utility of fruquintinib in this patient population. Specifically, Misniakiewicz highlighted the “exciting” progression-free survival (PFS) findings from the phase 3 FRESCO-2 trial (NCT04322539), which may affirm fruquintinib as a “promising treatment option” for those with refractory disease.


    According to previous findings from the FRESCO-2 trial published in Lancet Oncology, the median PFS was 3.7 months (95% CI, 3.5-3.8) with fruquintinib plus best supportive care vs 1.8 months (95% CI, 1.8-1.9) with placebo plus best supportive care (HR, 0.32; 95% CI, 0.27-0.39; P <.0001).2 Additionally, the median overall survival (OS) was 7.4 months (95% CI, 6.7-8.2) vs 4.8 months (95% CI, 4.0-5.8) in each respective arm (HR, 0.66; 95% CI, 0.55-0.80; P <.0001). PFS and OS benefits across various patient subgroups—in which investigators stratified patients based on previous treatment with trifluridine/tipiracil (Lonsurf) or regorafenib (Stivarga), RAS mutation status, and duration of metastatic disease—were comparable with those observed in the intent-to-treat population.


    “The truth is that treatment options for metastatic [CRC] are limited, and the approval of fruquintinib will hopefully bridge that gap a little bit,” Misniakiewicz said. “Oral agents have changed the landscape of treatment for patients with cancer. Furthermore, targeted agents allow us to tailor therapy with the goal of improving clinical outcomes while minimizing off target toxicities; fruquintinib will hopefully allow us to do this in patients with metastatic colorectal cancer.”


    References


    1. Takeda receives U.S FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer. News release. Takeda. November 8, 2023. Accessed June 6, 2024. https://bit.ly/3SwkD8U

    2. Dasari A, Lonardi S, Garcia-Carbonero R, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. Published online June 15, 2023. doi:10.1016/S0140-6736(23)00772-9
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    14 mins