Oncology On The Go

In a cobranded episode between Oncology On the Go, hosted by CancerNetwork®, and the American Society for Transplantation and Cellular Therapy (ASTCT)’s program ASTCT Talks, an expert panel explored when early antibiotic de-escalation may be feasible for pediatric populations who undergo hematopoietic cell transplantation. The panel was hosted by Diego R. Hijano, MD, MSc, who was joined by his colleagues Gabriela Marón, MD, MSc, and Fareed Khawaja, MBBS.
Marón began by contextualizing the traditional practice of continuing antibiotic therapy until neutrophil recovery, which was based on host defense physiology instead of clinical trial data. Prolonged antibiotic use, she said, may correspond with resistant pathogens, bloodstream infections, and increased intensive care unit mortality across pediatric populations. Additionally, a limited pipeline for new antibiotic agents, especially for pediatric patients, makes the prevention of resistance critical during patient care.
Khawaja continued the discussion by highlighting recent literature and randomized clinical trials supporting the de-escalation of gram-negative coverage within 48 to 72 hours if no infection source is identified. He referenced new guidelines from the European Conference on Infections in Leukaemia, which support de-escalating antibiotics at 40 to 72 hours if no clear source of fever appears. Another study published in 2023 showed that decreased antibiotic days resulted in similar rates of successful treatment, subsequent fever, and 30-day mortality. Additionally, advances such as improved blood culture incubation and PET scans may bolster the ability of clinicians to safely de-escalate treatment.
Future directions in the field, Khawaja said, may include investigating how aggressive stewardship impacts long-term outcomes while learning how to implement quality improvement programs. Marón also identified a need for more prospective pediatric trials and data on how the microbiome changes following prolonged antibiotic exposure.
Hijano is medical director of Occupational Health and director of the Infectious Disease, Bone Marrow Transplant, and Cellular Therapy Division at St. Jude Children’s Research Hospital. Marón is a pediatric infectious disease specialist who works with patients who undergo transplant at St. Jude Children’s Research Hospital. Khawaja is an associate professor of Infectious Diseases, Infection Control and Employee Health, and Internal Medicine at The University of Texas MD Anderson Cancer Center.
References

Averbuch D, Vanbiervliet Y, Baccelli F, et al. Empirical and targeted antimicrobial therapy in patients with febrile neutropenia and haematological malignancy or after haematopoietic cell transplantation: recommendations from the 10th European Conference on Infections in Leukaemia. Lancet Infect Dis. 2026;26(6):e232-e247. doi: 10.1016/S1473-3099(25)00619-X

Patel PA, Teherani MF, Xiang Y, et al. Short-course empiric antibiotics in children undergoing allogeneic hematopoietic cell transplantation. Transplant Cell Ther. 2023;29(12):778.e1-778.e6. doi:10.1016/j.jtct.2023.09.011

In September 2026, the FDA granted accelerated approval to sevabertinib (Hyrnuo) as a frontline treatment option for patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD)–activating mutations. The decision expanded sevabertinib’s indication from its accelerated approval in November 2025 as a therapy for patients who received prior systemic treatment.
To better understand the potential clinical implications of this expanded approval for sevabertinib, CancerNetwork® spoke with Xiuning Le, MD, PhD, about the findings supporting the agent’s clinical benefit and how it fits alongside other available options in the NSCLC space. Le, an associate professor in the department of Thoracic/Head and Neck Medical Oncology at UT MD Anderson Cancer Center, was the lead investigator of the phase 1/2 SOHO-01 trial (NCT05099172), which led to both of sevabertinib’s accelerated approvals.
Regarding sevabertinib’s label, Le highlighted the importance of mindfully interpreting the differences between TKD-activating mutations or insertions vs amplification, as precision oncology begins with the careful testing, detection, and interpretation of patient reports. She also described how the approval supplements the rapid evolution of HER2-directed therapy in lung cancer, as sevabertinib is now an option to consider alongside zongertinib (Hernexeos) and trastuzumab deruxtecan (Enhertu) across different treatment settings. 
Given sevabertinib’s accelerated approval status, Le outlined the next steps for affirming the agent’s benefit in the phase 3 SOHO-02 trial (NCT06452277), which is randomly assigning patients with treatment-naive, HER2 mutation-positive NSCLC to receive sevabertinib or chemoimmunotherapy. Le concluded by emphasizing the value of testing and identifying patients with actionable markers who may benefit from treatment with sevabertinib and other targeted agents.
“What I want to tell my peer oncologists is that HER2 is still a very new target. Make sure that you sequence all the [patients with] lung cancer to identify the HER2 mutation, as we're all learning how to use these medications,” Le said. “The first, most important part is to identify those patients. Once we identify those patients, then we can discuss which frontline [option] is the most appropriate. Testing still is the key.”
References

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer. News release. FDA. September 9, 2026. Accessed October 2, 2026. https://tinyurl.com/mwsay6jf

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. News release. FDA. November 19, 2025. Accessed October 2, 2026. https://tinyurl.com/mt455knh

A study to learn more about how well sevabertinib works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations of the human epidermal growth factor receptor 2 (HER2) (SOHO-02). ClinicalTrials.gov. Updated September 23, 2026. Accessed October 2, 2026. https://tinyurl.com/2k32z6wu

In this episode of Oncology On the Go, Daniel C. McFarland, DO, spoke with Yesne Alici, MD, who oversees Memorial Sloan Kettering Cancer Center (MSKCC)’s medical aid in dying (MAID) program. Together, they explored what MAID means for oncology practice now that it is legal in New York State.
Alici defined MAID as the legal practice in which a terminally ill, capacitated adult with a life expectancy of less than 6 months may request a prescription that they self-administer to hasten death. Self-administration, she noted, is the main distinction between MAID and euthanasia, which is not legal anywhere in the US. MAID is currently legal in 14 states and Washington, DC, giving roughly 1 in 3 US adults access, according to Alici. Even so, it accounts for less than 1% of all deaths in states where it is legal, and not every patient who inquires goes on to pursue it.
Drawing on MSKCC’s experience fielding inquiries from patients in New Jersey since 2019, Alici described a population that was mostly older and predominantly female, with about one-third of patients having early-stage cancer when they asked and most still receiving treatment. Nationally, the top reasons patients inquire are loss of dignity, loss of control, and loss of ability to enjoy activities, rather than physical symptoms like pain or shortness of breath.
The conversation also walked through New York’s safeguards, including multiple requests, 2 neutral adult witnesses, a decision-making capacity assessment, and a mandatory psychiatrist or psychologist evaluation, a requirement shared only with Hawaii. Alici argued that these assessments should be psycho-oncology informed and stressed the importance of approaching each request with neutrality, cautioning that conflating MAID with suicidal ideation risks alienating patients.
McFarland shared a challenging case involving voluntarily stopping eating and drinking, reflecting on clinicians’ own moral discomfort and on broader philosophical concerns about the romanticization of death. The pair also discussed the need for more research, the role of palliative care, and conscientious objection. Alici closed by urging oncologists who object to MAID to ensure that patients still have a path to discuss their inquiry, noting that New York law mandates offering a palliative care referral.
McFarland is the director of the Psycho-Oncology Program at Wilmot Cancer Center and a medical oncologist who specializes in head, neck, and lung cancer, in addition to being the psycho-oncology editorial advisory board member for the journal ONCOLOGY®. Alici is vice chair of clinical operations in the Department of Psychiatry and Behavioral Services, clinical director, associate attending psychiatrist, and medical director of the Biobehavioral Health Clinic at MSKCC.

At the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting, CancerNetwork® sat down with a variety of experts to discuss the latest data and emerging trends surrounding the management of different hematologic malignancies. Speakers and presentations covered everything from second primary malignancy risks to novel clinical trial findings across lymphoma, myelodysplastic syndrome (MDS), leukemia, and other patient patients.
First, Jasmine M, Zain, MD, an attending physician in the Lymphoma Service at Memorial Sloan Kettering Cancer Center, highlighted key takeaways from her presentation exploring the risk of secondary lymphoma malignancies following CAR T-cell therapy. In addition to discussing the incidence, mechanisms, and possible risk factors of these second malignancies, she detailed how to clinically differentiate between malignancies directly driven by retroviral or lentiviral insertional mutagenesis compared with those arising from cumulative genotoxic stress.
Additionally, David Sallman, MD, an associate member in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida, reviewed findings from the phase 2a HT-6184-MDS-001 trial (NCT07052006). In this study, Sallman and colleagues assessed ofirnoflast (HT-6184), a first-in-class oral allosteric NEK7 inhibitor designed to block NLRP3 inflammasome activation, in patients with lower-risk MDS who were refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents. Sallman discussed the platelet and neutrophil responses observed with ofirnoflast and how its intermittent, oral dosing schedule may protect long-term quality of life, especially among older patients with comorbidities.
Finally, Julie M. Vose, MD, MBA, the George and Peggy Payne Distinguished Chair of Oncology, professor in the Division of Hematology, and director of the Lymphoma Research Group at the University of Nebraska Medical Center, and co–editor in chief of ONCOLOGY®, spoke about general developments relating to the ever-evolving chronic lymphocytic leukemia (CLL) field. She detailed how minimal residual disease (MRD) testing may serve as an informative clinical decision-making tool, outlined strategies for community practices to keep up to date with the latest happenings in the space, and identified time-limited therapies as a key theme from the meeting.
References

Zain JM. Understanding the risk of second malignancies after CAR T therapies. Presented at: Society of Hematologic Oncology Annual Meeting; September 9-12, 2026; Houston, TX.

Sallman D, Bafna V, Nath UK, et al. Ofirnoflast (HT-6184), a first-in-class allosteric NEK7 inhibitor, achieves durable transfusion independence (TI) and hematological improvement-erythroid (HI-E) in ESA-refractory lower-risk myelodysplastic syndrome (LR-MDS): phase 2 final results. Presented at: 2026 SOHO Annual Meeting; September 9-12, 2026; Houston, TX.

The treatment paradigm for non–muscle invasive bladder cancer (NMIBC) has shifted considerably since the FDA established a formal definition of Bacillus Calmette-Guérin (BCG)–unresponsive disease, opening the door to a wave of new intravesical and gene therapies, according to Saum Ghodoussipour, MD.
In a conversation with CancerNetwork® on the Oncology On the Go podcast, Ghodoussipour, director of the Bladder and Urothelial Cancer Program at Rutgers Cancer Institute and associate professor of surgery at Robert Wood Johnson Medical School, discussed the distinction between real-world “BCG-exposed” disease and the FDA’s stricter, trial-oriented definition of BCG unresponsiveness. The agency’s definition accounts for persistent papillary disease, carcinoma in situ, or stage progression within specific timeframes following adequate BCG induction and maintenance.
Ghodoussipour walked through how the bladder-sparing armamentarium has expanded since 2020, when pembrolizumab (Keytruda) became the first novel agent approved for BCG-unresponsive disease. He detailed how nadofaragene firadenovec (Adstiladrin), nogapendekin alfa inbakicept-pmln (Anktiva), and TAR-200 (Inlexzo) have since given patients and clinicians a broader menu of options beyond radical cystectomy, each with distinct dosing schedules, response rates, and durability data drawn from single-arm trials.
He also addressed how a persistent global BCG shortage is reshaping treatment decisions, noting that some centers, including his own, have adopted third-dose maintenance schedules rather than full-dose, 3-year courses, informed by EORTC data showing no difference in progression or overall survival despite a modest reduction in recurrence prevention. Ghodoussipour further discussed how emerging comparative trials, such as the ECOG-led EA8212/BRIDGE trial (NCT05538663) evaluating BCG against gemcitabine/docetaxel combination therapy, may help resolve open questions around sequencing and allocation.1
On the surgical side, Ghodoussipour emphasized that radical cystectomy remains a guideline-recommended option for BCG-unresponsive disease and pointed to data from the CISTO trial (NCT03933826) suggesting that patient-reported quality of life may actually improve after cystectomy compared with prolonged bladder-sparing attempts.2 Still, he noted that improving risk stratification, using biomarkers such as circulating tumor DNA and the AI-driven Vesta Bladder test, may help identify which patients are the best candidates for continued bladder preservation.
“[NMIBC] has been booming the last few years,” Ghodoussipour said. “I'm fortunate to have been in such an exciting space because…it's getting better for our patients. But in order for us to reach the point where we can confidently and consistently cure these patients, we really got to get down to tumor biology.”
Throughout the conversation, Ghodoussipour underscored the importance of multidisciplinary collaboration among urologists, medical oncologists, and radiation oncologists as systemic therapies and checkpoint inhibitor combinations, including regimens studied in the phase 3 CREST (NCT04165317) and POTOMAC trials (NCT03528694), increasingly enter the BCG-naive and BCG-unresponsive settings.3,4 He also stressed that shared decision-making, better patient-reported outcome data, and continued discovery work into tumor biology will be essential to bring greater consistency to treatment sequencing in the years ahead.
References

1. Intravesical BCG vs GEMDOCE in NMIBC (BRIDGE). Clinicaltrials.gov. Updated July 17, 2026. Accessed September 9, 2026. https://tinyurl.com/w9axbzks
2. Gore JL, Wolff EM, Nash MG, et al. Twelve-month results from the CISTO study comparing radical cystectomy versus bladder-sparing therapy for recurrent high-grade non-muscle-invasive bladder cancer. J Clin Oncol. 2025;44(4):274-285. doi:10.1200/JCO-25-01324
3. Powles T, Shore N, Galsky M, et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. J Clin Oncol. 2025;43(suppl 17):4517. doi:10.1200/JCO.2025.43.16_suppl.4517
4. De Santis M, Redorta J, Nishiyama H, et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. The Lancet. 2025;406(10516):2221-2234. doi:10.1016/S0140-6736(25)01897-5