S13 Ep29: FDA Approval Insights: Oncomine DX Express Test Companion Diagnostic for Sunvozertinib in Non–Small Cell Lung Cancer: With Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP

In today’s episode, supported by Thermo Fisher Scientific, we had the pleasure of speaking with Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP, about the FDA approval of the Oncomine DX Express Test for use as a companion diagnostic for sunvozertinib (Zegfrovy) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer and for use in tumor profiling. Dr Ganti is a professor in the University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center in Omaha. Dr Cushman is the Henry F. Krous Professor of Pathology, a professor in the UNMC Department of Pathology, Microbiology and Immunology, director of the Division of Diagnostic Molecular Pathology and Human Genetics, medical director of the Molecular Diagnostics and Personalized Medicine Laboratory at Nebraska Medicine, director of the Molecular Genetic Pathology Fellowship Program, and associate director of the UMNC MD-PhD Scholars Program.  In our exclusive interview, Drs Ganti and Cushman discussed the significance of the launch of the Oncomine DX Express Test, the benefits and limitations of rapid next-generation sequencing, and features that set Oncomine DX apart from other available tests. 

In today’s episode, supported by Coherus BioSciences, we had the pleasure of speaking with Justine Bruce, MD, about the ongoing evolution of nasopharyngeal carcinoma management. Dr Bruce is a faculty member in the Division of Hematology, Medical Oncology and Palliative Care within the Department of Medicine at the University of Wisconsin, as well as the director of the VA Medical Oncology Clinical Research Program and chair of the Protocol Review and Monitoring Committee at the University of Wisconsin Carbone Cancer Center in Madison. In our exclusive interview, Dr Bruce discussed evolving treatment strategies for nasopharyngeal cancer, emphasizing the shift from chemoradiation followed by adjuvant chemotherapy to induction chemotherapy with gemcitabine and cisplatin. She also noted how toripalimab-tpzi (Loqtorzi) combined with gemcitabine and cisplatin showed improved overall survival (OS) in the first-line setting in the phase 3 JUPITER-02 trial (NCT03581786). Bruce also expressed her preference for OS as the gold standard for determining the efficacy of nasopharyngeal cancer treatments and noted the need for more US-based trials to reflect the local patient population.

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 a discussion of key data from the phase 3 MATTERHORN trial (NCT04592913), which were presented at the 2025 ASCO Annual Meeting. MATTERHORN was a randomized, double-blind, multinational study evaluating the addition of durvalumab (Imfinzi) to FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) in patients with previously untreated, resectable gastric or gastroesophageal junction adenocarcinoma. In the MATTERHORN trial, 948 patients were randomly assigned 1:1 to receive either durvalumab or placebo in combination with perioperative FLOT, followed by 10 cycles of durvalumab or placebo as adjuvant therapy. The primary end point was event-free survival (EFS); secondary end points included overall survival (OS) and pathological complete response (pCR). The trial met its primary end point. Durvalumab plus FLOT (n = 474) significantly improved EFS vs placebo plus FLOT (n = 474; HR, 0.71; 95% CI, 0.58-0.86; P < .001), representing a 29% reduction in risk of progression, recurrence, or death. The interim OS analysis showed a nonsignificant trend favoring durvalumab (HR, 0.78; 95% CI, 0.62-0.97; P = .025). The pCR rate was 19% (95% CI, 15.75%-23.04%) with durvalumab vs 7.2% (95% CI, 5.02%-9.88%) with placebo. Toxicity profiles were comparable between the 2 groups, though immune-related adverse effects were more frequent with durvalumab. Importantly, the addition of durvalumab did not delay surgery or initiation of adjuvant therapy. Although the MATTERHORN regimen is not yet FDA approved or included in the National Comprehensive Cancer Network guidelines, this trial demonstrates a promising EFS benefit and potential practice-changing implications, pending mature OS data and further molecular subgroup analyses, according to Armstrong and Tawagi.

In today’s episode, supported by Bayer, we had the pleasure of speaking with Alicia Morgans, MD, MPH, and Neal Shore, MD, FACS, about the FDA approval of darolutamide (Nubeqa) plus androgen deprivation therapy for patients with metastatic castration-sensitive prostate cancer (mCSPC). Morgans is the medical director of the survivorship program at Dana-Farber Cancer Institute; as well as an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts. Shore is the medical director of the Carolina Urologic Research Center. In our exclusive interview, Drs Morgans and Shore discussed the significance of this approval; key efficacy, safety, and quality of life data from the pivotal phase 3 ARANOTE trial (NCT04736199); and how this regulatory decision both opens doors for the treatment of more patients and raises questions about the optimal role of darolutamide in the management of mCSPC. 

In this episode of MedNews Week's Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was rejoined by Midhun Malla, MD, of the University of Alabama at Birmingham, to discuss therapeutic options for patients with metastatic colorectal cancer (mCRC), particularly in the third-line setting and beyond. In the final part of this 3-part episode miniseries, Drs Park and Malla explored the challenges faced by community oncologists, especially in rural or underserved areas, in accessing clinical trials, which remain a preferred disease management approach due to their role in advancing novel therapies. However, in the absence of trial availability or when patients are ineligible, they emphasized the importance of evidence-based, FDA-approved agents for later lines of therapy. Three primary agents were discussed for patients who have progressed on first-line FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and second-line FOLFIRI (folinic acid, fluorouracil, and irinotecan) regimens: trifluridine/tipiracil (TAS-102; Lonsurf) plus bevacizumab (Avastin); fruquintinib (Fruzaqla); and regorafenib (Stivarga). These agents offer viable treatment pathways in biomarker-unselected patient populations. However, direct comparisons between these agents are lacking, as most were tested against placebo controls. The choice among them is often individualized based on patient performance status, prior exposure to biologics, and toxicity profiles. TAS-102 plus bevacizumab has generated promising results, though real-world data may show diminished efficacy due to frequent prior exposure to 5-fluorouracil and bevacizumab in US patients. Fruquintinib offers a VEGF-targeted approach with a more favorable hematologic toxicity profile, whereas regorafenib is associated with notable adverse effects, including hypertension, gastrointestinal toxicity, and mucositis. Park and Malla emphasized the importance of treatment sequencing, toxicity management, and individualized patient-centered care, including consideration of dose modifications to preserve quality of life in later-line settings. In addition to later-line options, the conversation also touched on emerging frontline therapies. Notable investigational agents include zanidatimab-hrii (Ziihera) and KRAS G12C–directed therapies. Additionally, a novel integrin-targeted cytotoxin is currently under evaluation at the University of Alabama at Birmingham in patients with treatment-naive mCRC. This agent induces apoptosis via caspase-8 activation and has demonstrated encouraging preclinical activity. Overall, the discussion highlighted a nuanced, biomarker-informed, and patient-tailored approach to mCRC management, emphasizing both the value of clinical trials and the importance of optimizing currently available therapies.

In today’s episode, supported by Immatics, we had the pleasure of speaking with Justin Moser, MD, about the ongoing phase 3 SUPRAME trial investigating the PRAME-directed T-cell receptor T-cell therapy IMA203 vs treatment of physician's choice in patients with previously treated, unresectable or metastatic cutaneous melanoma. Dr Moser is an associate clinical investigator, a melanoma and cutaneous oncology specialist, and a phase 1 trialist at HonorHealth Research Institute in Scottsdale, Arizona; as well as a research associate professor at the Arizona State University School of Medicine and Advanced Medical Engineering. In our exclusive interview, Dr Moser discussed the unique mechanism of action of IMA203, previously reported phase 1 data with this agent in patients with melanoma, and the design and potential future implications of SUPRAME. 

In this episode of MedNews Week's Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was rejoined by Midhun Malla, MD, a gastrointestinal oncologist at Allegheny Health Network in Pittsburgh, Pennsylvania, to discuss treatment personalization in metastatic colorectal cancer (mCRC), with a focus on BRAF V600E–mutant tumors, HER2-altered disease, and the clinical implications of tumor sidedness.

In today’s episode, supported by Daiichi Sankyo, we had the pleasure of speaking with Misako Nagasaka, MD, PhD, about the use of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in pretreated patients with HER2-mutated non–small cell lung cancer (NSCLC). Dr Nagasaka is an associate professor in the Division of Hematology and Oncology and the Division of Medicine at the University of California Irvine School of Medicine. In our exclusive interview, Dr Nagasaka discussed current second-line treatment standards for patients with HER2-mutated NSCLC, how the use of T-DXd in this setting may evolve with the emergence of investigational agents, and the importance of integrating HER2 immunohistochemistry testing into clinical practice.

In this episode, OncLive On Air® partnered with Two Onc Docs to bring discussion of data from the phase 3 SERENA-6 trial (NCT04964934), which were presented at the 2025 ASCO Annual Meeting. SERENA-6 evaluated switching to camizestrant plus a CDK4/6 inhibitor vs continuing with a standard-of-care aromatase inhibitor plus a CDK4/6 inhibitor in the frontline setting in patients with hormone receptor–positive, HER2-negative advanced breast cancer whose tumors harbor an emergent ESR1 mutation. Drs Armstrong and Tawagi highlighted key efficacy, safety, and patient-reported outcomes from the study. They also noted the clinical implications of these findings, including how they might be currently applicable to clinical practice, as well as limitations of the research that warrant further investigation. 

In today’s episode, supported by Coherus BioSciences, we had the pleasure of speaking with Michael Dennis, MD, about recent updates to the nasopharyngeal carcinoma treatment paradigm. Dr Dennis is a physician at Dana-Farber Cancer Institute; as well as an instructor in medicine at Harvard Medical School, both in Boston, Massachusetts. In our exclusive interview, Dr Dennis discussed the latest National Comprehensive Cancer Center guideline updates for the treatment of patients with nasopharyngeal carcinoma; practice-informing data from the phase 3 JUPITER-02 trial (NCT03581786), which investigated first-line toripalimab-tpzi (Loqtorzi) plus chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma; and ongoing developments in the locally advanced treatment setting.