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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

Jeneth Aquino, DNP, FNP-BC; Beth Sandy, MSN, CRNP, FAPO; Allison M. Walker, ACNP, MSN, MSW, BS

Differentiating Adverse Events for Antibody-Drug Conjugates Across Solid Tumor Management

Benjamin P. Levy, MD; John O. Mascarenhas, MD; Tiffany A. Traina, MD, FASCO; Cathy Eng, MD, FACP, FASCO; John P. Leonard, MD

 42nd Annual CFS: Chemotherapy Foundation Symposium®: Innovative Cancer Therapy for Tomorrow

This approval of durvalumab marks the first and only perioperative immunotherapy regimen available in muscle-invasive bladder cancer.


FDA Grants Approval to Durvalumab in MIBC

Belzupacap sarotalocan showed rapid immune activation and a favorable safety profile as a treatment for non–muscle-invasive bladder cancer.

Bel-Sar Shows Promising Clinical and Immune Activity in NMIBC

A propensity-score matched cohort study found a significantly reduced risk of recurrence of bladder cancer in patients who had blue light vs white light cystoscopy. 

Blue Light Cystoscopy Associated With Lower Risk of Recurrence of NMIBC

An expanded access program evaluating cretostimogene grenadenorepvec was highlighted during the 25th Annual Meeting of the Society of Urologic Oncology.

EAP Enhances Access to Cretostimogene Grenadenorepvec

Jason M. Hafron, MD, CMO, discusses recent approvals in the non–muscle-invasive bladder cancer space and data from several clinical trials evaluating agents for bladder cancer.

Expert Explores Trials in CIS-Refractory Bladder Cancer

Petros Grivas, MD, PhD, discusses challenges in cancer care in the bladder cancer setting.

Barriers Considered When Treating Patients With Bladder Cancer

Petros Grivas, MD, PhD, clinical director of the genitourinary cancers program at University of Washington Medicine and professor at Fred Hutchinson Cancer Center in Seattle, Washington, discusses challenges in cancer care in the bladder cancer setting.

The first barrier Grivas notes is limited infusion room capacity and the need for rapid chair turnover. Other external barriers for patients include transportation and lodging. Grivas highlights that healthcare disparities remain a global concern.

Regulatory approvals, NCCN guidelines, and insurance coverage decisions impact treatment accessibility for patients with bladder cancer. Advances in next-generation sequencing, molecular profiling, and HER2 testing—especially with trastuzumab deruxtecan’s (Enhertu) approval in 2024—offer promising opportunities. The field is making progress, improving patient outcomes, and ongoing clinical trials aim to further enhance future treatments. Efforts continue to optimize efficiency, equity, and care quality in oncology, according to Grivas.

Sometimes barriers may include a certain capacity and bandwidth that we have in the infusion rooms, infusion suites these days in the cancer centers, the need for a rapid turnover of the infusion chairs—but that's an issue across the board, I would say. We always want to strive to give the best possible care for the patients, and that's what we're striving for. I always think about efficiencies and the ways to be more efficient in clinic. Also, patients sometimes may have challenges in terms of transportation, in terms of lodging, their own time, so we need to make sure we meet that need. Obviously, the issue of healthcare disparities is a major issue globally, and it's something that always is relevant in those discussions.

Regulatory approvals and NCCN and other guidelines are relevant to support even the decision by payers, insurance companies, whether to cover some particular medications, particular therapies. And, of course, there are opportunities for broader use of tumor next-generation sequencing, molecular profiling, as well as HER2 immunohistochemistry staining based on the gastric cancer calling algorithm in the setting of the recent approval of trastuzumab deruxtecan across tumor types. So overall, we're very excited about the progress being made in the field and the better outcomes for our patients, and we keep accruing in clinical trials in order to try to make the future even better for our patients and further improve the outcomes through ongoing research.

Videos

Updated Findings on Datopotamab Deruxtecan in Urothelial Cancer Treatment

Funda Meric-Bernstam, MD, chair of the Department of Investigational Cancer Therapeutics (Phase 1 Program) at The University of Texas MD Anderson Cancer Center, discusses what a community oncologist should get from updated findings from the phase 1 TROPION-PanTumor01 study (NCT03401385) of datopotamab deruxtecan-dlnk (Datroway) in patients with heavily pretreated locally advanced or metastatic urothelial cancer, presented at the 

2025 ASCO Genitourinary Cancer Symposium.

 This is an agent that is FDA-approved for breast cancer, not yet for urothelial cancer, but I think that it definitely is an agent with potential for urothelial cancer on the horizon. Also, it is something that I think can be considered as relatively safe, as it doesn't have neuropathy, so in a patient who's had problems with neuropathy, it could be a consideration, and again, with less pulmonary concerns compared with other drugs and pain options.

We were aware of TROP2 as a target. And more recently, there has been an approval and then withdrawal of another ADC that targets TROP2. So, that was at least in part because of the challenge of managing cytopenia in a multicenter trial setting, and you could see how that would be very relevant to the community setting. So, from that standpoint, I think DATO-DXd very favorably compares, because really, we do not see cytopenia as an [adverse] effect, and that also enhances the possibility of combination.

From the patient selection standpoint, this trial was an unselected trial, so we did not look for TROP2 expression for enrollment. And of course, we know that TROP2 is frequently expressed, but it is important to note, in some other diseases, there is data emerging that expression may matter and we can even further enhance that space. In lung cancer, there is exploration of quantitative imaging with a continuous scoring strategy. So, I think more is yet to come to see if we can better identify patients that would benefit even more from DATO-DXd either from the payload or from expression.

 It is definitely, I think, an active enough agent to start thinking about where we would position it. And again, given the exciting activity so far with enfortumab vedotin-ejfv [Padcev] and pembrolizumab [Keytruda], it will be interesting to see whether there are patients that would benefit from something targeted instead, if we had a selection strategy. And also, I think we are thinking about strategies like utilizing it in the adjuvant setting, or potentially in the adjuvant setting.

Meric-Bernstam F, Alhalabi O, Lisberg A, et al. Datopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: updated results from the phase 1 TROPIONPanTumor01 study. 

2025;43(suppl 5):663. doi:10.1200/JCO.2025.43.5_suppl.663

Funda Meric-Bernstam, MD, discusses updated findings from the phase 1 TROPION-PanTumor01 study of datopotamab deruxtecan-dlnk in heavily pretreated locally advanced or metastatic urothelial cancer.

News

Avelumab Maintenance in Advanced Urothelial Carcinoma: Key Insights

Shilpa Gupta, MD, director, genitourinary medical oncology, Taussig Cancer Institute, and co leader of the genitourinary oncology program at Cleveland Clinic, discusses the key takeaways from the long-term outcomes of the JAVELIN Bladder 100 (NCT02603432) trial for community oncologists, particularly regarding the impact of avelumab (Bavencio) as first-line maintenance.

Findings presented at the 2025 Genitourinary Cancers Symposium showed that when given with best supportive care (BSC) in the first-line maintenance setting, avelumab led to improved overall survival and progression-free survival rates compared with BSC alone in patients with advanced urothelial carcinoma, regardless of diabetes mellitus status.

These findings come from exploratory analyses from the phase 3 JAVELIN Bladder 100 trial. The study included patients with unresectable locally advanced or metastatic urothelial carcinoma who remained progression free after 4 to 6 cycles of first-line platinum-based chemotherapy.

Once enrolled in the trial, patients were assigned to receive frontline maintenance with avelumab and BSC or BSC alone. The exploratory analysis evaluated long-term efficacy and safety outcomes within the subgroups of patients with or without documented diabetes mellitus at randomization.

From the community oncology perspective, I think this is important information for them to know that if patients cannot get [enfortumab vedotin with pembrolizumab] in the frontline, this is a very reasonable regimen.

And some of the reasons patients may not be able to get [enfortumab vedotin with pembrolizumab] or if they have severe baseline peripheral neuropathy. So, in that case, they could use gemcitabine, [carboplatin], followed by nivolumab [Opdivo] maintenance

Gupta S, Grivas P, Park SH, et al. Avelumab first-line maintenance (1LM) in patients (pts) with advanced urothelial carcinoma (aUC) with or without diabetes mellitus (DM): long-term outcomes from JAVELIN Bladder 100. 

. 2025;43(suppl 5):869. doi:10.1200/JCO.2025.43.5_suppl.869

Shilpa Gupta, MD, discusses the key takeaways from the long-term outcomes of the JAVELIN Bladder 100 trial for community oncologists.


Conference News

Petros Grivas MD, PhD, discusses immunotherapy trials in muscle-invasive and metastatic bladder cancer.

IO Trials Change Practice in Localized and Metastatic Bladder Cancer

Petros Grivas, MD, PhD, clinical director of the genitourinary cancers program at University of Washington Medicine and professor at Fred Hutchinson Cancer Center in Seattle, Washington, discusses the key trials of bladder cancer using immunotherapy (IO) he highlighted during a Case-Based Roundtable event.

Grivas said that in the localized bladder cancer setting, he examined data from the CheckMate 274 trial (NCT02632409) supporting adjuvant nivolumab (Opdivo), the AMBASSADOR trial (NCT03244384) of adjuvant pembrolizumab (Keytruda), and the NIAGARA trial (NCT03732677) of neoadjuvant and adjuvant durvalumab (Imfinzi). The NIAGARA trial combined durvalumab with gemcitabine/cisplatin before surgery and continued durvalumab afterward. The trial showed event-free survival and overall survival benefit 

leading to the FDA granting priority review

 in early December, and Grivas said the participants discussed the practice-changing potential of these data.

In the metastatic setting, he discussed the JAVELIN Bladder 100 (NCT02603432), CheckMate 901 (NCT03036098), and EV-302 (NCT04223856) trials which each have had practice-changing impact over the past several years using IO. In particular, updated data from the CheckMate 901 trial of gemcitabine/cisplatin plus nivolumab vs gemcitabine/cisplatin showed its improvement in efficacy with consistent tolerability. The EV-302 trial added enfortumab vedotin (Padcev) to pembrolizumab and showed significantly better outcomes vs platinum-based chemotherapy in patients who were not previously treated in the locally advanced/metastatic setting. Their discussion of these trials showed how the trial data is quickly being adopted in community and academic practices and also shed light on barriers and opportunities for implementing these treatments.

 We talked about localized bladder cancer, muscle invasive disease, and the adjuvant therapy data with checkpoint inhibition. We covered the data from the CheckMate 274 trial with adjuvant nivolumab vs placebo and the corresponding FDA and EMA approval a few years ago. We also covered the AMBASSADOR trial that was recently presented at [the 2024 European Society of Medical Oncology Annual Congress] with a corresponding 

 publication by Dr Apolo in our group. And we discussed the nuances, details, efficacy data in terms of disease-free survival, overall survival, and toxicity data as well.

We also covered the NIAGARA trial, this perioperative trial using neoadjuvant and adjuvant durvalumab, a checkpoint inhibitor against PD-L1 in patients who have localized muscle-invasive bladder cancer. The neoadjuvant durvalumab was given together with gemcitabine/cisplatin neoadjuvantly, then adjuvant durvalumab alone and the comparator arm was neoadjuvant gemcitabine/cisplatin alone. The trial showed significant event-free survival and overall survival benefit. We're waiting to see the regulatory agency's decision about the efficacy and safety data, and we had the chance to discuss the potential practice-changing nature of this data, how the group feels about it and how they will plan in the future to possibly implement changes in their clinical practice, taking into account, as I mentioned, the totality of the efficacy and safety data from those trials.

We also discussed metastatic disease. We focused mainly in the frontline setting of metastatic urothelial carcinoma from bladder or other parts of the urinary tract. We discussed the data from the 3 practice-changing trials, Javelin Bladder 100, CheckMate 901, and EV 302. We focused a little bit more on the last 2 trials that were more recent as of ESMO 2023 and later, and we covered, again, efficacy and toxicity data from CheckMate 901, with gemcitabine/cisplatin nivolumab vs gemcitabine/cisplatin, as well as EV 302 with pembrolizumab/enfortumab vs platinum-based chemotherapy. And it was a great discussion, again, illustrating how quickly the field is moving forward, and what the reaction is by colleagues in the community and academic practices in terms of the adoption of the data sets and, of course, barriers and opportunities for further improvement.

Petros Grivas, MD, PhD, discusses the key trials of bladder cancer using immunotherapy he highlighted during a Case-Based Roundtable event.

Behind the Phase 1 Study of TAR-210 in FGFR-Altered NMIBC

Antoni Vilaseca Cabo, MD, adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, discusses the rationale behind the phase 1 study (NCT05316155) evaluating the safety and efficacy of TAR-210 in patients with 

-altered high- and intermediate-risk non–muscle invasive bladder cancer (NMIBC), highlighting its methods and design.

 We know that even with some available treatments, recurrence rates for patients with NMIBC remain high, highlighting the need for more effective therapies. Activating 

 alterations are present in about 50% to 80% of patients with advanced bladder cancer, and these are known to be potential oncogenic drivers.

We also have a drug, erdafitinib, a selective pan-FGFR tyrosine kinase inhibitor, which has shown good results in metastatic and advanced urothelial carcinoma. It is already approved in the US and other countries for patients following first-line systemic treatment. In a previous study, called THOR-2 [NCT04172675], we observed some activity with systemic use of erdafitinib in NMIBC. However, systemic [adverse] effects were likely too high for this patient population. To address this, a new intravesical drug delivery system has been designed to evaluate the use of erdafitinib locally, aiming to reduce systemic toxicities while maintaining its efficacy.

This study has different cohorts and we presented data from cohorts 1 and 3. Cohort 1 included patients with high-risk NMIBC. These were patients with recurrent high-grade TA or T1 papillary tumors, without carcinoma in situ, and all had previously been treated with BCG. Cohort 3 included patients with intermediate-risk NMIBC. These patients had a history of recurrent low-grade TA or T1 disease. All patients in this cohort had visible tumors in the bladder before starting treatment. The study used an accumulation design, and all patients in both cohorts had 

 alterations identified either in tissue samples or through cell-free DNA from urine.

Antoni Vilaseca Cabo, MD, discusses the rationale behind the phase 1 study evaluating the safety and efficacy of TAR-210 in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer.

Petros Grivas of Fred Hutchinson discusses sequencing checkpoint inhibitors in bladder cancer.

Trials Needed for Sequencing Checkpoint Inhibitors in Bladder Cancer

Petros Grivas, MD, PhD, clinical director of the genitourinary cancers program at University of Washington Medicine and professor at Fred Hutchinson Cancer Center in Seattle, Washington, elaborates on some key unanswered questions on approaches to bladder cancer treatment he discussed with participants at a Case-Based Roundtable event.

Grivas said that one of the biggest questions he discussed with other oncologists is how to treat patients who have received immune checkpoint inhibitors such as nivolumab (Opdivo) and pembrolizumab (Keytruda) in the adjuvant or neoadjuvant setting. Since these regimens were introduced recently, it’s not known whether patients can be rechallenged with checkpoint inhibitors after metastatic recurrence.

No trials have addressed this question yet, but in kidney cancer, there were negative results from the CONTACT-03 (NCT04338269) and TiNivo-2 (NCT04987203) trials. These trials investigated adding checkpoint inhibitors in the second-line metastatic setting in patients who received them in the prior line. Although this could be extrapolated to conclude that rechallenge would not be effective in bladder cancer, trials in this bladder cancer setting would be ideal, Grivas said.

Other sequencing questions pose challenges as well, such as what to give after pembrolizumab plus enfortumab vedotin (Padcev) and how to sequence other therapies with erdafitinib (Balversa) when given to patients with 

Finally, he said that research into driver mutations for bladder cancer has shown the importance of germline mutation testing to patients and their families. Testing and genetic counseling can lead to screening for other cancers for early detection.

I think this is really showing the interest that bladder cancer as a disease has attracted over the last decade. With more therapy options for our patients, there are many unanswered questions, and that's why we need clinical trials to answer those questions. For example, what is the role of rechallenging patients with a checkpoint inhibitor if they already received that checkpoint inhibitor before in the localized disease setting, perioperatively or adjuvantly? Do you use a checkpoint inhibitor again, maybe concurrently with enfortumab, if the patient has a metastatic recurrence? That's an ongoing question. I think we've tried hard to answer those questions through clinical trials.

There are different perceptions, of course, across experts. If someone has progression on checkpoint inhibitor, we have lessons learned from kidney cancer, for example, that based on trials, they are the CONTACT-03 and the TiNivo-2, that rechallenge with a checkpoint inhibitor after progression on checkpoint inhibitor did not benefit patients. The CONTACT-03 and TiNivo-2 were negative trials. How do these data extrapolate or apply to metastatic urothelial carcinoma? We need, ideally, trials in that setting to answer this question of checkpoint inhibitor rechallenge in this disease.

Of course, [we have] many other questions [such as] subsequent therapies after pembrolizumab and enfortumab, optimal sequencing of therapies, the role again, of next-generation sequencing, [and] erdafitinib, how do you sequence that FGFR inhibitor after frontline therapy.

The other parallel thing is that we learn more and more about germline mutations in urothelial carcinoma. There is a more and more need to send these patients for germline testing and genetic counseling to benefit the patient, and also the broader family in terms of cancer prevention screening, etc.

Petros Grivas, MD, PhD, elaborates on some key unanswered questions on approaches to bladder cancer treatment he discussed with participants at a Case-Based Roundtable event.

Rana McKay discusses CheckMate 274, AMBASSADOR, and NIAGARA

Differing Trial Designs for Immunotherapy in MIBC Yield Favorable Outcomes

Rana R. McKay, MD, professor of medicine and urology at UC San Diego School of Medicine, discusses the significance of clinical trial data for immunotherapy in muscle-invasive bladder cancer (MIBC) treatment she presented at a Case-Based Roundtable event.

At the event, she discussed data such as an update from the CheckMate 274 trial (NCT02632409) of nivolumab (Opdivo) vs placebo as adjuvant therapy for MIBC. The overall survival (OS) data favored nivolumab in the intent-to-treat population and even more strongly in the population of PD-L1 expression 1% or higher. Investigators in the AMBASSADOR/A031501trial (NCT03244384) reported disease-free survival (DFS) benefit with pembrolizumab (Keytruda) vs observation in the neoadjuvant setting but OS data were immature. This trial was notable for allowing patients with positive margins after resection to enroll.



Rana R. McKay, MD, discusses the significance of clinical trial data for immunotherapy in muscle-invasive bladder cancer (MIBC) treatment she presented at a Case-Based Roundtable event.

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