Hematology/Oncology from MDedge
Existing biosimilars are safe, effective alternatives to their reference biologics, and are increasingly being incorporated into oncology treatment guidelines.
Technological advances that have emerged in the years since biologic agents entered the market allow for the careful assessment of “critical clinical attributes” of biosimilar agents. This helps ensure the safety and efficacy of biosimilars, as well as their structural, functional, and behavioral similarities to the original reference biologics, according to Gary Lyman MD, MPH, professor and senior lead, health care quality and policy at the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center, Seattle.
Biosimilars are increasingly being included as acceptable alternatives in treatment guidelines, and in this episode Dr. Lyman discussed the reasons why they are considered safe and effective, how they can add value for oncology patients, and the need for ongoing diligence in monitoring their effects.
Biosimilars in oncology – key points:
Show notes written by Sharon Worcester, MA, a reporter for MDedge and Medscape.
Disclosures
Dr. Henry has no relevant disclosures. Dr. Lyman disclosed relationships with Amgen, Jazz Pharmaceuticals, Partners Therapeutics, Sandoz, Seattle Genetics, Bristol Myers Squibb, BeyondSpring, Samsung, G1 Therapeutics, and Merck.
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Systemic treatment for advanced urothelial cancer is quickly evolving. On this week’s podcast, Arjun Balar, MD, director of the genitourinary medical oncology program at New York University discusses his approach amid changing times with guest host Alan Lyss, MD, a community-based medical oncologist and clinical researcher in the St. Louis area before his recent retirement.
Chemotherapy or immunotherapy first line?
Antibody-drug conjugates
Next-generation sequencing
Enfortumabe vedotin adverse events
Show notes written by M. Alexander Otto.
Dr. Balar disclosed research, advisory, and/or speaker relationships with Genentech, Incyte, Bristol-Myers Squibb, Janssen, Merck, Pfizer, AstraZeneca, and other companies. Dr. Lyss writes a column for MDedge Hematology/Oncology called “Clinical Insights” and had no other conflicts of interest.
A “very basic” type of gene therapy could potentially cure hemophilia, but a major hurdle has been the lack of an effective mode of delivery. Recent strides in using adeno-associated virus (AAV) vectors are changing that, and Glenn Pierce, MD, World Federation of Hemophilia Vice President, Medical, predicts approvals in the next 12-18 months.
Dr. Pierce shared his personal experience with hemophilia and discussed his and others’ ongoing research on the use of AAV-mediated gene therapy with host David Henry, MD, in this episode.
Hemophilia and AAV gene therapy key points:
Show notes written by Sharon Worcester, MA, a reporter for MDedge and Medscape.
Disclosures
Dr. Henry has no relevant disclosures. Dr. Pierce disclosed relationships with Ambys Medicines, BioMarin, BridgeBio, CRISPR Therapeutics, Decibel Therapeutics, Frontera, Geneception, Generation Bio, Novo Nordisk, Pfizer, Regeneron, Third Rock Ventures, Voyager Therapeutics, Global Blood Therapeutics, VarmX SAB, the National Hemophilia Foundation Medical and Scientific Advisory Council, and the World Federation of Hemophilia.
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At least 17 cases of thrombosis and thrombocytopenia have been reported in patients who received the Johnson & Johnson COVID-19 vaccine in the United States. Such events have been reported in patients who received the AstraZeneca vaccine as well. In this episode, Adam C. Cuker, MD, of the University of Pennsylvania, Philadelphia, tells host David H. Henry, MD, how to identify and manage patients with these vaccine-induced events. What’s in a name?
Incidence unclear
Diagnosing VITT
Manage VITT like HIT
Show notes written by M. Alexander Otto, a reporter for MDedge and Medscape.
Disclosures Dr. Henry has no relevant disclosures. Dr. Cuker has served as a consultant for Synergy Pharmaceuticals; has received authorship royalties from UpToDate; and his institution has received research support on his behalf from Alexion, Bayer, Novartis, Novo Nordisk, Pfizer, Sanofi, Spark Therapeutics, and Takeda.
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The combined clinical cell-cycle risk (CCR) score uses clinical and genetic factors to assess the risk of metastasis after radiation therapy in patients with prostate cancer.
The CCR score has proven accurate in studies and can guide post-radiation treatment decisions in practice, according to Jonathan D. Tward, MD, PhD, of the University of Utah, Salt Lake City.
Dr. Tward discusses the CCR score with host David Henry, MD, in this episode.
About the score
CCR score proves effective
CCR score bests other scoring systems
Show notes written by Sharon Worcester, a reporter for MDedge and Medscape.
Disclosures
Both studies were funded by Myriad Genetics, the company that developed the Prolaris test. Dr. Tward disclosed relationships with Myriad Genetics and other companies. Dr. Henry has no relevant disclosures.
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Pediatric oncologists are used to dealing with emotional, heart-wrenching situations, but oncology took on a new dimension for Michael Weiner, MD, when both he and his daughter were diagnosed with cancer.
Dr. Weiner, a pediatric oncologist at Columbia University, New York, describes his roles as oncologist, patient, and caregiver to host David H. Henry, MD, in this episode.
Oncologist as patient: Lessons learned
Oncologist as caregiver: Taking a backseat
Dr. Weiner recounts these experiences in his book “Living Cancer: Stories from an Oncologist, Father, and Survivor,” which can be found here: https://bit.ly/3n7TB5Z.
Show notes written by M. Alexander Otto, a reporter for MDedge and Medscape.
Disclosures
Dr. Weiner and Dr. Henry have no relevant disclosures. These show notes were updated on 4/22.
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Studies have shown that chimeric antigen receptor (CAR) T-cell therapies produce responses in patients with relapsed/refractory B-cell lymphomas, but researchers continue to look for ways to improve efficacy, decrease toxicity, and overcome treatment resistance.
Leslie Kean, MD, PhD, of Boston Children’s Hospital, discusses some of this research with host David H. Henry, MD, in this episode.
Dr. Kean outlines four recent studies of CAR T-cell therapies in lymphoma. The studies were selected as part of the “Best of ASH” session at the 2020 annual meeting of the American Society of Hematology. Primary Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
What’s involved in a CAR T-cell study?
Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 ELARA Trial
TRANSCEND CLL 004: Phase 1 Cohort of Lisocabtagene Maraleucel (liso-cel) in Combination with Ibrutinib for Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
CD58 Aberrations Limit Durable Responses to CD19 CAR in Large B Cell Lymphoma Patients Treated with Axicabtagene Ciloleucel But Can Be Overcome Through Novel CAR Engineering
Looking ahead: Concerns about cost
Show notes written by Malika Gill, MD, a resident at Pennsylvania Hospital, Philadelphia.
Disclosures Dr. Henry has no relevant disclosures. Dr. Kean disclosed relationships with Magenta Therapeutics, Bristol-Myers Squibb, Kymab, HiFiBiO Therapeutics, Regeneron, Novartis, Gilead, Bluebird Bio, and Forty Seven.
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Email the show: [email protected]
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David Henry on Twitter: @davidhenrymd
Researchers have tracked the evolution of genetic germline testing in women with breast or ovarian cancer in recent years and reported the results in the Journal of Clinical Oncology. Study author Allison W. Kurian, MD, of Stanford (Calif.) University, describes the group’s findings (https://bit.ly/31RaSGR) to guest host Alan Lyss, MD, subprincipal investigator emeritus for Heartland Cancer Research NCORP, in this episode.
Study rationale and methods
Results by hypothesis
Hypothesis 1: Multigene panels will entirely replace testing for BRCA1/2 only.
Hypothesis 2: Underutilization of testing patients with ovarian cancer will improve over time.
Hypothesis 3: More patients will be tested at lower levels of pretest risk for PVs.
Hypothesis 4: Sociodemographic difference in testing trends would not be seen.
Hypothesis 5: Detection of PVs and VUS will increase.
Hypothesis 6: Racial or ethnic disparities in rates of VUS will diminish over time.
Additional findings and implications for practice
Show notes written by Alesha Levenson, MD, a resident at Penn Medicine, Philadelphia.
Disclosures
Dr. Kurian disclosed relationships with Myriad Genetics, Ambry Genetics, Color Genomics, GeneDx/BioReference, InVitae, and Genentech. The study was supported by the National Cancer Institute, the Centers for Disease Control and Prevention, and the California Department of Public Health.
Dr. Lyss writes a column for MDedge Hematology/Oncology called “Clinical Insights” (https://bit.ly/3m76xIP). He has no other conflicts of interest.
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Dr. Lyss on Twitter: @HeartlandOncDoc
A program called Drive By Flu-FIT has allowed for socially distanced colorectal cancer (CRC) screening during the COVID-19 pandemic.
Armenta Washington, senior research coordinator at the University of Pennsylvania, describes the program to guest host Alan Lyss, MD, subprincipal investigator emeritus for Heartland Cancer Research NCORP, in this episode.
What is Drive By Flu-FIT?
How does Drive By Flu-FIT work?
Results: High return rate
Resources
Ms. Washington disclosed no conflicts of interest. The study was supported by the National Cancer Institute. The FITs were donated by Polymedco, and the flu vaccines were donated by the Philadelphia Public Health Department.
Dr. Lyss writes a column for MDedge Hematology/Oncology called “Clinical Insights” (https://bit.ly/3m76xIP). He has no other conflicts of interest.
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For more MDedge Podcasts, go to mdedge.com/podcasts
Email the show: [email protected]
Interact with us on Twitter: @MDedgehemonc
Dr. Lyss on Twitter: @HeartlandOncDoc
Earlier this year, clinical practice guidelines for the diagnosis and management of von Willebrand disease (VWD) were published in Blood Advances.
The guidelines (https://bit.ly/2OIfKLE) are a collaborative effort from the American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia.
Guideline author Paula James, MD, of Queens University, Kingston, Ont., reviews some of the recommendations in these guidelines with host David H. Henry, MD, in this episode.
Case discussion
A patient presents with the complaint of heavy menstrual bleeding, which could indicate a bleeding disorder such as VWD. How does one diagnose or rule out VWD?
Diagnostic evaluation of VWD
Types of VWD
Pregnant patients with VWD
Procedural planning: Desmopressin challenge test
Recommendations for preprocedure prophylaxis for type 1 VWD
Preprocedure prophylaxis in type 2 or 3 VWD
Show notes written by Sheila DeYoung, DO, a resident at Pennsylvania Hospital, Philadelphia.
Disclosures
Dr. Henry has no relevant disclosures. Dr. James disclosed relationships with Baxter/Baxalta/Shire, CSL Behring, Bayer, and Octapharma.
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For more MDedge Podcasts, go to mdedge.com/podcasts
Email the show: [email protected]
Interact with us on Twitter: @MDedgehemonc
David Henry on Twitter: @davidhenrymd
We continue our review of drugs recently approved by the Food and Drug Administration (FDA) in the hematology/oncology space. In part 1 of our review, David M. Mintzer, MD, of Pennsylvania Hospital, highlighted 11 therapies, including newly-approved treatments and new indications for older drugs. Part 1 was published Feb. 18 (https://bit.ly/38JR782). Now, in part 2, Dr. Mintzer tells host David H. Henry, MD, about another 11 therapies recently approved by the FDA, including monoclonal antibodies, kinase inhibitors, chimeric antigen receptor (CAR) T-cell therapies, and more. Margetuximab-cmkb (Margenza)
In Dec. 2020, margetuximab-cmkb was approved for use in combination with chemotherapy to treat adults with metastatic, HER2-positive breast cancer who had received at least two prior anti-HER2 regimens, including at least one for metastatic disease. https://bit.ly/38JAiKg
Tafasitamab-cxix (Monjuvi)
In July 2020, tafasitamab-cxix received accelerated approval for use in combination with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem cell transplant. https://bit.ly/3vtiHQF
Lurbinectedin (Zepzelca)
In June 2020, lurbinectedin received accelerated approval to treat adults with metastatic small-cell lung cancer with disease progression on or after platinum-based chemotherapy. https://bit.ly/30KcnpB
Belantamab mafodotin-blmf (Blenrep)
In Aug. 2020, belantamab mafodotin-blmf received accelerated approval to treat adults with relapsed or refractory multiple myeloma who had received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. https://bit.ly/3lkPLWd
Umbralisib (Ukoniq)
In Feb. 2021, the FDA granted umbralisib accelerated approval to treat adults with relapsed or refractory marginal zone lymphoma who had received at least one prior anti-CD20-based regimen and adults with relapsed or refractory follicular lymphoma who had received at least three prior lines of systemic therapy. https://bit.ly/3bQqtMM
Azacitidine tablets (Onureg)
In Sept. 2020, the FDA approved azacitidine tablets for continued treatment of patients with acute myeloid leukemia who had achieved a first complete remission or complete remission with incomplete blood count recovery after intensive induction chemotherapy and who are not able to complete intensive curative therapy. https://bit.ly/38KFT2Z
Decitabine and cedazuridine tablets (Inqovi)
In July 2020, the FDA approved an oral combination of decitabine and cedazuridine to treat adults with myelodysplastic syndromes (MDS). This includes previously treated and untreated, de novo and secondary MDS (including refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia), as well as intermediate-1, intermediate-2, and high-risk MDS. https://bit.ly/3lmqlI4
Tepotinib (Tepmetko)
In Feb. 2021, the FDA granted accelerated approval to tepotinib for adults with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. https://bit.ly/3lmqBXy
Pralsetinib (Gavreto)
In Sept. 2020, pralsetinib received accelerated approval to treat adults with metastatic RET fusion-positive NSCLC. https://bit.ly/3vrS26I
In Dec. 2020, the FDA granted full approval to pralsetinib to treat adult and pediatric patients ages 12 and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or those with RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine. https://bit.ly/3eCVXrs
Brexucabtagene autoleucel (Tecartus)
In July 2020, the FDA granted accelerated approval to brexucabtagene autoleucel, a CD19-directed CAR T-cell therapy, for the treatment of adults with relapsed or refractory mantle cell lymphoma. https://bit.ly/3tBtqH9
Lisocabtagene maraleucel (Breyanzi)
In Feb. 2021, another CD19-directed CAR T-cell therapy, lisocabtagene maraleucel, was approved to treat adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approval encompasses DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. https://bit.ly/3lljHBx
Disclosures
Dr. Mintzer and Dr. Henry have no relevant disclosures.
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For more MDedge Podcasts, go to mdedge.com/podcasts
Email the show: [email protected]
Interact with us on Twitter: @MDedgehemonc
David Henry on Twitter: @davidhenrymd
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