S14 Ep26: FDA Approval Insights: Sunvozertinib in EGFR-Mutated Metastatic NSCLC: With Lyudmila Bazhenova, MD

In today’s episode, we had the pleasure of speaking with J. Thaddeus Beck, MD, FACP, about the FDA approval of pembrolizumab and berahyaluronidase alfa-pmph (subcutaneous pembrolizumab; Keytruda Qlex) for subcutaneous injection in adult and pediatric patients at least 12 years of age with solid tumors for which the intravenous formulation of pembrolizumab (Keytruda) is indicated.

Cancer, Character, and Calling: The Oncologist's Journey, hosted by Girindra Raval, MD, is a podcast highlighting how top oncologists have navigated the field over the course of their careers, the passion that drove them to enter the oncology space, and the ongoing work that will continue to transform cancer care. Each episode, Raval will sit down with a top oncologist to dive into their background, highlight their career achievements, discuss key issues still being addressed in their field, and explore their interests outside of the clinic and lab. In this episode, Raval welcomed Anand Jillella, MD, who is the J. Harold Harrison, MD Distinguished University Chair in Medicine, a professor of medicine & pediatrics, and chief of the Division of Hematology/Oncology at Augusta University Medical College of Georgia. He is also associte director of Clinical Affairs and director of the Georgia Cancer Center Clinic, Ambulatory Services, and Network and Outreach. Their conversation focused on discussed Jillella's career journey, starting from his oncology internship in 1989 to establishing a bone marrow transplant program. Jillella noted the initial successes of the program that led to its exponential growth over the years. He also emphasized the importance of community outreach and collaboration with referring practices, explaining the early work that he and colleagues did to maintain working relationships with other practices and get the program on the map. Furthermore, Jillella highlighted the historical development of the treatment algorithm for patients with acute promyelocytic leukemia, emphasizing that proper physician training and research significantly reduced mortality rates in this disease over the years. Raval and Jillella concluded by addressed the evolving landscape of oncology, the growing effects of AI tools on medical practice patterns, and the need for academic institutions to stay on the cutting edge of new treatments and technologies to advance the field and ultimately improve patient care.

In today’s episode, leading experts across oncology specialties previewed the key studies and data they are most anticipating ahead of the 2025 ESMO Congress. Dana M. Chase, MD, a professor of Clinical Obstetrics and Gynecology in the Division of Gynecologic Oncology at UCLA, discussed her excitement to see findings from a phase 1 trial (NCT05403554) investigating NI-1801 in patients with heavily pretreated, mesothelin-expressing platinum-resistant epithelial ovarian cancer. Premal H. Thaker, MD, MS, the David G. and Lynn Mutch Distinguished Professor of Obstetrics and Gynecology and director of Gynecologic Oncology Clinical Research at Siteman Cancer Center in Saint Louis, Missouri, discussed the anticipation for findings from a multi-omic analysis of the phase 3 AtTEnd/ENGOT-EN7 trial (NCT03603184) of atezolizumab in patients with endometrial cancer and data demonstrating that the WES-derived Aneuploidy Score may identify patients with mismatch repair–deficient endometrial cancer who derive reduced benefit from immunotherapy. Zev Wainberg, MD, the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research at UCLA, shared his anticipation for new data in gastrointestinal oncology, particularly the overall survival results from the phase 3 MATTERHORN trial (NCT04592913) of durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel in patients with resectable gastric and gastroesophageal cancer, which are expected to provide pivotal updates following previously reported event-free survival outcomes. Sagus Sampath, MD, an associate clinical professor and medical director of the Department of Radiation Oncology at City of Hope in Duarte, California, highlighted the phase 2 NorthStar trial (NCT03410043) evaluating osimertinib (Tagrisso) with or without local consolidative therapy in patients with metastatic EGFR-mutated non–small cell lung cancer (NSCLC).

In today’s episode, we had the pleasure of speaking with Joseph Jacob, MD, MCR, about the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo)​ for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer. Dr Jacob is an associate professor of urology and the director of Urologic Oncology in the Department of Urology at State University of New York Upstate Medical University in Syracuse. In our exclusive interview, Dr Jacob discussed the significance of this approval, key efficacy findings from the pivotal phase 2b SunRISe-1 trial (NCT04640623), and the TAR-200 administration procedure, which he describes as straightforward for practitioners and convenient for patients.

In today’s episode, we had the pleasure of speaking with Lyudmila Bazhenova, MD, about the FDA approval of sunvozertinib (Zegfrovy) for patients with EGFR-mutated metastatic non–small cell lung cancer (NSCLC). Dr Bazhenova is a clinical professor of medicine at the University of California San Diego (UCSD); as well as a medical oncologist at the UCSD Moores Cancer Center. In our exclusive interview, Dr Bazhenova discussed the significance of this approval, key efficacy and safety data from the pivotal the phase 1/2 WU-KONG1B trial (NCT03974022), and how the use of sunvozertinib in the NSCLC treatment paradigm may propel future possibilities for the use of EGFR-directed agents in this disease.

In today’s episode, we had the pleasure of speaking with Kanwal P. S. Raghav, MBBS, MD, about the role of fruquintinib (Fruzaqla) in the treatment of adult patients with pretreated, metastatic colorectal cancer (CRC). Dr Raghav is a professor in the Department of Gastrointestinal Medical Oncology in the Division of Cancer Medicine, associate vice president of the Department of Ambulatory Medical Operations, and executive medical director of the Department of Ambulatory Treatment Centers at The University of Texas MD Anderson Cancer Center in Houston. In our exclusive interview, Dr Raghav discussed the mechanism of action of fruquintinib, key efficacy data from the phase 3 FRESCO (NCT02314819) and FRESCO-2 (NCT04322539) trials, the treatment settings where this agent is most frequently administered, and adverse effects to be aware of. He also noted how the role of fruquintinib in earlier lines of therapy has yet to be defined due to a lack of optimal predictive biomarkers. Dr Raghav concluded by emphasizing the importance of clinical trials for improving outcomes for patient with CRC.

In today’s episode, we had the pleasure of speaking with Anne Chiang, MD, PhD, and Stephen Liu, MD, about the FDA approval of lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide. Chiang is an associate professor of medicine in the Section of Medical Oncology and the associate cancer center director of Clinical Initiatives at the Yale School of Medicine in New Haven, Connecticut. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. In our exclusive interview, Drs Chiang and Liu discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 IMforte trial (NCT05091567), and how the addition of this regimen in the ES-SCLC treatment paradigm may affect clinical practice.

In today’s episode, we had the pleasure of speaking with Stephen Liu, MD, about the use of tepotinib (Tepmetko) in patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. In our exclusive interview, Dr Liu discussed key efficacy and safety findings from the phase 2 VISION trial (NCT02864992) that led to the FDA approval of tepotinib for this indication; the comparable response rates seen between tissue and liquid biopsy results, as well as across NSCLC treatment lines; and the importance of early biomarker testing, including RNA sequencing, to identify actionable mutations and optimize treatment.

In today’s episode, we had the pleasure of speaking with Andrew Kuykendall, MD, who gave an overview of the myelofibrosis treatment paradigm. Dr Kuykendall is an assistant member in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida.   In our exclusive interview, Dr Kuykendall discussed the prevalence of patients with myelofibrosis who have mutations in JAK2, CALR, or MPL; the crucial roles of the JAK1, JAK2, and IRAK1 pathways in disease progression; the importance of considering JAK inhibition in eligible patients; and the challenges associated with managing cytopenic myelofibrosis.

In our exclusive interview, Dr Shitara discussed preliminary efficacy data with CAR T-cell therapy in gastrointestinal cancers; highlighted challenges related to durability of response, patient selection, and manufacturing logistics with these therapies; and outlined ongoing biomarker analyses exploring tumor microenvironment factors influencing resistance.