OncLive® On Air

In today’s episode, supported by Citius Pharmaceuticals, we had the pleasure of speaking with Francine Foss, MD, to discuss the FDA approval of denileukin diftitox-cxdl (Lymphir) for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL) who have received 1 or more prior systemic therapies. Dr Foss is a professor of medicine (hematology) and dermatology and the director of the Multidisciplinary T Cell Lymphoma Program at the Yale School of Medicine, as well as the scientific leader of Lymphoma CRT at Yale Cancer Center in New Haven, Connecticut.  On August 8, 2024, the FDA approved denileukin diftitox for the treatment of patients with relapsed/refractory CTCL who have received at least 1 prior systemic therapy. This regulatory decision was supported by findings from the phase 3 Study 302 (NCT01871727), in which patients who received the agent (n = 69) achieved an objective response rate of 36.2% (95% CI, 25.0%-48.7%) per independent review committee assessment, including a complete response rate of 8.7%. In our exclusive interview, Dr Foss discussed the significance of this approval, key efficacy and safety data from Study 302, and her excitement about reintroducing an agent to the CTCL treatment paradigm that can induce particularly robust responses.

Dr Patil emphasized the significance of the phase 3 CROWN trial (NCT03052608), which compared lorlatinib (Lorbrena) with crizotinib (Xalkori) in patients with ALK-positive metastatic NSCLC. With a hazard ratio of 0.19 (95% CI, 0.13-0.27) for progression-free survival, the trial demonstrated lorlatinib’s superior intracranial control and long-term efficacy compared with crizotinib, especially in patients with brain metastases. Drs Park and Patil also discussed challenges associated with managing lorlatinib-related toxicities, including mood changes, weight gain, and hyperlipidemia. Dr Patil suggested that starting at a lower dose and gradually escalating to the recommended dose could help mitigate some of these adverse effects and simultaneously maintain treatment efficacy. The conversation concluded with a shift towards the broader application of targeted therapies in earlier disease stages, drawing parallels between the phase 3 ALINA study (NCT03456076) in patients with ALK-positive

In today’s episode, supported by Sobi, we had the pleasure of speaking with Aaron T. Gerds, MD, MS, and James K. McCloskey, MD, about myelofibrosis treatment advances. Dr Gerds is an assistant professor in the Department of Medicine in the School of Medicine, as well as a member of the Developmental Therapeutics Program at the Case Comprehensive Cancer Center in Cleveland, Ohio. He is also a physician in the Department of Hematology and Medical Oncology at Cleveland Clinic. Dr McCloskey is the interim chief of the Division of Leukemia at Hackensack John Theurer Cancer Center in New Jersey.  In our exclusive interview, Drs Gerds and McCloskey discussed factors that influence their choice between the variety of JAK inhibitors that are FDA approved for patients with myelofibrosis, tips for symptom management in this disease, and emerging myelofibrosis research to look out for. 

In today’s episode, supported by Servier Pharmaceuticals, we had the pleasure of speaking with Jennie W. Taylor, MD, MPH, about the FDA approval of vorasidenib (Voranigo) for patients with IDH-positive grade 2 astrocytoma or oligodendroglioma. Dr Taylor is an associate professor of clinical neurology at the University of California, San Francisco (UCSF), as well as the community engagement liaison in the Neurologic Oncology Program at the UCSF Helen Diller Family Comprehensive Cancer Center. On August 6, 2024, the FDA approved vorasidenib for the treatment of adult and pediatric patients at least 12 years of age with grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations who have previously undergone surgery including biopsy, sub-total resection, or gross total resection. This regulatory decision was backed by findings from the phase 3 INDIGO trial (NCY04164901), in which, at a median follow-up of 14.0 months (interquartile range [IQR], 10.1-17.9), vorasidenib (n = 168) produced a median progression-free survival of 27.7 months (95% CI, 17.0-not estimated) vs 11.1 months (95% CI, 11.0-13.7) in the placebo arm (n = 163) at a median follow-up of 14.3 months (IQR, 10.0-18.1; HR, 0.39; 95% CI, 0.27-0.56; P < .001). In our exclusive interview, Dr Taylor discussed the significance of this approval, key data from INDIGO, and where vorasidenib fits into the astrocytoma or oligodendroglioma treatment paradigms.

In our exclusive interview, Dr Dietrich discussed key efficacy findings from the 18-month follow-up of the phase 2 VISION trial (NCT02864992), which evaluated the efficacy of tepotinib (Tepmetko) in patients with non–small cell lung cancer harboring MET exon 14 skipping mutations. Additionally, Dr Dietrich emphasized important safety considerations with tepotinib, particularly the management of on-target adverse effects (AEs) like edema. He also discussed strategies for addressing treatment-related AEs, such as hyperalbuminemia, hyponatremia, and kidney function abnormalities, and highlighted the importance of careful monitoring to make dose adjustments as necessary.

In today’s episode, supported by AstraZeneca, we had the pleasure of speaking with Sandip P. Patel, MD, and Brendon M. Stiles, MD, about the FDA approval of perioperative durvalumab (Imfinzi) for patients with resectable non–small cell lung cancer (NSCLC). Dr Patel is a professor of medicine in the Department of Medicine at the University of California, San Diego. Dr Stiles is a professor of cardiothoracic surgery and chief of the Divisions of Thoracic Surgery and Surgical Oncology in the Department of Cardiothoracic & Vascular Surgery, as well as the associate director of Surgical Oncology at the Montefiore Einstein Comprehensive Cancer Center in Bronx, New York. On August 15, 2024, the FDA approved durvalumab plus platinum-containing chemotherapy in the neoadjuvant setting, followed by durvalumab monotherapy in the adjuvant setting, for the treatment of adult patients with resectable NSCLC with no known EGFR mutations or ALK rearrangements. This regulatory decision was backed by findings from the phase 3 AEGEAN trial (NCT03800134), in which the median event-free survival was not reached (95% CI, 31.9 months-not estimable [NE]) in patients who received the durvalumab regimen vs 25.9 months (95% CI, 18.9-NE) in those who received placebo plus chemotherapy (stratified HR, 0.68; 95% CI, 0.53-0.88; P = .0039). In our exclusive interview, Drs Patel and Stiles discussed the significance of this approval, key efficacy and safety findings from AEGEAN, and how the clinical use of perioperative treatment regimens reinforces the importance of involving multidisciplinary teams in every step of a patient’s treatment plan.

In part 2 of this 3-part Oncology Unplugged series, Chandler Park, MD, a genitourinary medical oncologist at Norton Cancer Institute in Louisville, Kentucky, and Tejas Patil, MD, an assistant professor of medical oncology at the University of Colorado School of Medicine in Aurora, discussed the evolving small cell lung cancer (SCLC) treatment paradigm. They examined critical data from recent studies, focusing on the role of prophylactic cranial irradiation (PCI) and the effects of immune checkpoint inhibitors in both limited-stage SCLC (LS-SCLC) and extensive-stage SCLC (ES-SCLC).

Two Onc Docs, hosted by Samantha A. Armstrong, MD, and Karine Tawagi, MD, is a podcast dedicated to providing current and future oncologists and hematologists with the knowledge they need to ace their boards and deliver quality patient care. Dr Armstrong is a hematologist/oncologist and assistant professor of clinical medicine at Indiana University Health in Indianapolis. Dr Tawagi is a hematologist/oncologist and assistant professor of clinical medicine at the University of Illinois in Chicago. In this episode, OncLive On Air® partnered with Two Onc Docs to bring you a curated list of resources to use as you study for the hematology and oncology board exams. Drs Armstrong and Tawagi discussed their personal board review plans they followed in the months leading up to boards, including the books, sections of the National Comprehensive Cancer Network Guidelines, videos, question banks, and podcasts; where you can find the “cheat sheets” they made to help them study; and the importance of personalizing your study plan based on your own knowledge and strengths. 

In today’s episode, we had the pleasure of speaking with Rory Shallis, MD, an assistant professor of medicine and hematology at Yale School of Medicine, part of Yale New Haven Health in Connecticut. Shallis sat down with us to share some of the research that has been generated in myelodysplastic syndrome (MDS) over the past year or so, touching on the evolution of clinical trial end points and where the field is headed in terms of therapeutic classes. He also spoke to the investigation of the late-stage erythroid maturation agent luspatercept-aamt (Reblozyl) in this population in the phase 3 ELEMENT-MDS (NCT05949684) and MAXILUS (NCT06045689) trials. In our exclusive interview, Shallis discussed the research basis for the ELEMENT-MDS trial in MDS, the potential of intervening with luspatercept before patients become red blood cell transfusion dependent, and aspects of the trial to be aware of for patient enrollment.

Dr Warner discusses the FDA approval of afami-cel for patients with advanced synovial sarcoma and key findings from the pivotal SPEARHEAD-1 trial.