OncLive® On Air

In today’s episode, we had the opportunity to speak with Arndt Vogel, MD, about the European Commission’s (EC's) July 2025 marketing authorization of zanidatamab-hrii (Ziihera) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic HER2-positive biliary tract cancer. Dr Vogel is a faculty member at the University of Toronto Institute of Medical Science, a scientist at the Toronto General Hospital Research Institute, and a medical oncologist at the UHN–Princess Margaret Cancer Centre in Canada.

In our exclusive interview, Dr Vogel highlighted the clinical importance of this decision, emphasizing that it represents a significant advancement for a molecularly defined subgroup of patients with limited treatment options and historically poor outcomes. He explained that biliary tract cancers, including cholangiocarcinoma, are associated with high recurrence rates and poor survival, even in patients who undergo curative-intent surgery. For patients in the advanced setting, second-line chemotherapy offers modest clinical benefit, with objective response rates of approximately 6%, a median progression-free survival of approximately 3 months, and a median overall survival of approximately 12 months.

Vogel discussed the data supporting the EC’s approval, which was based on findings from the phase 2b HERIZON-BTC-01 trial (NCT04466891)—the largest study conducted to date evaluating HER2-directed therapy in this patient population. In the trial, at a median follow-up of 21.9 months, patients with centrally confirmed HER2-positive tumors (n = 80) who received zanidatamab achieved a confirmed objective response rate (cORR) of 41.3% (95% CI, 30.4-52.8). The median duration of response was 14.9 months (95% CI, 7.4-not reached), and the median overall survival reached 15.5 months (95% CI, 10.4-18.5).

In today’s episode, we had the pleasure of speaking with Jonathan M. Gerber, MD; and Shyam A. Patel, MD, PhD, about a study they conducted investigating the use of immunohistochemistry (IHC) as a biomarker for early TP53 mutation identification in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Dr Gerber is a member of the faculty in the Department of Medicine at New York University (NYU) Grossman School of Medicine; as well as the chief clinical officer of the NYU Perlmutter Cancer Center. Dr Patel is an associate professor at the University of Massachusetts Chan Medical School; as well as a hematologist and oncologist at the UMass Memorial Medical Center in Worcester. 

In our exclusive interview, Drs Gerber and Patel discussed the evaluation of p53 IHC as a surrogate biomarker for TP53-mutant MDS and AML. They shared how the presence of TP53 mutations in these diseases significantly worsens prognosis, necessitating urgent treatment. They also highlighted how IHC results are available within 48 to 72 hours. Gerber and Patel explained this study's design and patient population, as well as how IHC's inverse correlation with overall survival highlights its potential as an early biomarker, though it has lower sensitivity for certain mutations.

In today’s episode, we had the opportunity to speak with Henry M. Kuerer, MD, PhD, FACS, CMQ, about the potential to safely omit surgery in a subset of patients with early-stage HER2-positive or triple-negative breast cancer who achieve a pathologic complete response (pCR) following neoadjuvant systemic therapy. Dr Kuerer is a professor of breast surgical oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas.

In our conversation, Dr Kuerer reviewed the rationale behind a prospective phase 2 clinical trial (NCT02945579) testing image-guided vacuum-assisted core biopsy to identify patients with no residual disease after neoadjuvant therapy. He outlined the strict technical and eligibility criteria that enabled accurate detection of pCR—including tumors downsizing to less than 2 cm and biopsy of at least 12 cores from the tumor bed—and discussed why this biopsy-based approach may be more reliable than standard surgery in detecting residual disease. He also highlighted the broader clinical implications of the findings, noting that patients with biopsy-confirmed pCR may proceed directly to radiotherapy and avoid breast surgery altogether.

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.

How This Is Building Me, hosted by world-renowned oncologist D. Ross Camidge, MD, PhD, is a podcast focused on the highs and lows, ups and downs of all those involved with cancer, cancer medicine, and cancer science across the full spectrum of life’s experiences.

In this episode, Dr Camidge sat down with Catharine Young, PhD, who is currently a senior fellow at the Harvard T. H. Chan School of Public Health. Young was formerly the assistant director of Cancer Moonshot Policy and International Engagement in the White House Office of Science and Technology Policy in Washington, DC.

Camidge and Young, a South African–born scientist, discussed Young's journey from Johannesburg to Charlotte, North Carolina. Young shared that after undergrad, where she majored in biology, she joined a post-baccalaureate fellowship at the National Institute of Alcoholism and Alcohol Abuse, sparking her passion for research. This led her to pursue a PhD in biomedical sciences at the University of Missouri, focusing on the brain’s role in regulating blood pressure. Catherine noted the challenges of changing labs mid-PhD and her eventual decision to step away from academia.

During her postdoc, Young was inspired by her advisor's science policy fellowship, leading her to pursue a fellowship herself. She was matched with the US Department of Defense, working on chemical and biological threat reduction in former Soviet states and West Africa during the Ebola outbreak. Though she described the experience was eye-opening, she eventually shifted career paths, realizing that long-term government work wasn’t the right fit for her career goals.

From there, Young worked for the British Embassy in Washington, DC, bridging UK and US science priorities. She then joined the Biden Cancer Initiative, continuing the Cancer Moonshot’s momentum through its ups and downs. Young reflected on how her variety of experiences led her to launch the Cancer Moonshot to new heights as she worked to advance cancer research and patient care through cancer-related policy and global engagement. Young concluded by highlighting her passion for continuing to expand medical treatment access worldwide.

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.