BRAIN CANCER

HER2 Breast Cancer

BREAST CANCER

Bladder Cancer

Prostate Cancer

Renal Cell Carcinoma

GENITOURINARY CANCERS

Liquid Biopsies

GENOMIC TESTING

Colorectal Cancer

GIST

Gastric Cancer

GI CANCERS

Cervical Cancer

Endometrial Cancer

Ovarian Cancer

GYNECOLOGIC CANCERS

HEAD & NECK CANCERS

Bone Marrow & Stem Cell Transplant

HEMATOLOGY

CAR T-Cell Therapy

IMMUNOTHERAPY

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

LEUKEMIAS

Biomarker-Driven Lung Cancer

EGFR+ Lung Cancer

MET-Targeted Therapy

Small Cell Lung Cancer

LUNG CANCER

DLBCL

Follicular Lymphoma

Mantle Cell Lymphoma

LYMPHOMAS

MPNs

MULTIPLE MYELOMA

NTRK GENE FUSIONS

SARCOMA

Melanoma

SKIN CANCERS

THYROID CANCERS

NEWS

All News

FDA Briefs

Oncology Icons

Special Reports

The Targeted Pulse

Voices from the Field

CONFERENCES

Conference Coverage

Conference Listing

Data Dialogue with the Oncology Brothers

MEDIA

All Videos

Case-Based Peer Perspectives

Expert Perspective Virtual Tumor Board

Interviews

Investigator Perspectives

Medical World News

Pivotal Practice Views with the Oncology Brothers

Podcasts

Precision Medicine

Speaking Out

PUBLICATIONS

All Publications

Evolving Paradigms

Peers & Perspectives in Oncology

Targeted Therapies in Oncology

CASE-BASED ROUNDTABLE

PARTNERS

RESOURCES

CME/CE

Clinical Trials

Events

Precision Medicine Perspectives

Press Releases

Treatment Resources

SUBSCRIBE

Targeted Oncology provides news, videos, and reviews on the rapidly evolving world of targeted therapies and immunotherapy for oncologists treating patients in a community setting.

About Us

Advertise

Contact Us

CureToday.com

CancerNetwork.com

OncLive.com

OncNursingNews.com

Do Not Sell My Information

Privacy

Terms & Conditions

Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways

Facebook

Linkedin

YouTube

Instagram

Featured Clinical Focus

BTK Inhibitors: In-Focus

Bone Marrow & SCT

EGFR-Positive Lung Cancer

Lung Cancer

Multiple Myeloma

Thyroid Cancers

Clinical Focus

Brain Cancer

Breast Cancer

Gastrointestinal Cancer

Genitourinary Cancers

Gynecologic Cancers

Head & Neck Cancers

Hematology

Leukemias

Lymphomas

Sarcoma

Skin Cancers

Spotlight

1rem

Clinical

Benjamin P. Levy, MD; John O. Mascarenhas, MD; Alison J. Moskowitz, MD; Diane Reidy-Lagunes, MD; Tiffany A. Traina, MD, FASCO; David R. Wise, MD, PhD

 41st Annual CFS®: Innovative Cancer Therapy for Tomorrow

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

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time oncology review, expediting access to this potential treatment.

FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC

TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

FDA Clears NMIBC Agent TYRA-300 for Phase 2 Trial

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

FDA Grants Priority Review to Durvalumab in MIBC

In an interview, Antoni Vilaseca Cabo, MD, discussed the clinical activity of TAR-210 in patients with non-muscle invasive bladder cancer.

FGFR-Altered NMIBC Treatment Advances With TAR-210 Findings

The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.

Intravesical Mitomycin Demonstrates Significant Duration of Response in NMIBC

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.

Videos

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.

News

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.



McKay also brought up the NIAGARA trial (NCT03732677) of durvalumab (Imfinzi) plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone. She said this study allowed patients with a creatinine clearance of greater than 40 mL/min per 1.73 m

, a lower threshold than some other studies. The durvalumab arm had superior event-free survival, but she said questions remained since these patients received durvalumab before and after resection. It did not investigate whether patients could avoid adjuvant immunotherapy following a pathologic complete response (pCR). Additionally, the comparator arm did not receive any adjuvant immunotherapy although other studies have now shown this to be beneficial.

 There was a lot of discussion around the role of adjuvant immunotherapy for people with high-risk localized MIBC at the time of cystectomy, evolving data from CheckMate 274, now we see longer-term follow-up data. We've seen OS data that certainly appear to be suggesting that patients may derive an OS benefit with this regimen, particularly those individuals [who] are PD-L1 positive. With the AMBASSADOR study, definitely positive trial with regards to DFS. This was a study that looked at adjuvant pembrolizumab—some slight differences with the enrollment criteria in that this trial did allow patients with positive surgical margins to enroll. The DFS was positive for pembrolizumab. The OS data are still immature.

We also chatted about the NIAGARA data of perioperative durvalumab/cisplatin-based chemotherapy in the perioperative setting. The uniqueness of this study was it actually allowed enrollment of patients with a GFR [glomerular filtration rate] of greater than 40 [mL/min per 1.73 m2] so it had a slightly lower GFR threshold than historically utilized, and patients received cisplatin, gemcitabine, durvalumab, pre- and post- surgery and the post-surgery treatment was not dependent on pathologic responses at the time of surgery, and the control arm patients did not receive adjuvant immunotherapy. So there are some questions that are left unanswered with the NIAGARA study, particularly around [whether] patients with a pCR need outback treatment, and then what's the performance of the control arm in the context of adjuvant immunotherapies now demonstrating improvements in outcomes?

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.

Envisioning Integrated AI Tools for Precision Pathology

Anil Parwani, MD, PhD, professor of pathology at The Ohio State University Wexner Medical Center, explains his visions and plans for further development and integration of artificial intelligence (AI) technology in cancer diagnosis and prognosis.

According to Parwani, his goal is to develop a comprehensive AI tool that functions similarly to widely-used applications like Microsoft Word or email to provide a holistic view of patient health. This tool would potentially feature advanced capabilities, including heat maps to indicate cancer location and extent. He also explains that the ideal tool would integrate various data points, including genomics and blood tests.

 Ultimately, what would be great is to have a tool, like a more pan AI tool, not just focused on prostate cancer or bladder cancer or gastric cancer, but this becomes an app on your monitor just like Microsoft Word or an email where, when it is launched, [we] can see a heat map of where the cancer is, how much of the cancer there is, and start to create very powerful signatures of the patient's outcomes, looking at the whole patient, not just their prostate, and getting a more integrated view of the patient with their genomics and with their blood tests.

 Ultimately, many of the many data points that we collect in medicine are in silos. They are in different systems, and the goal will be [to see] if AI can help us bring this information together to know exactly what is going on with these patients. Even though 2 patients have the same disease, their cancer is very different, even though it looks the same. So, can we go beyond just a very superficial diagnosis and grading by AI, [and] create a more comprehensive, predictive profile of their disease or their cancer and make it so it is precision pathology? My vision is to create precision pathology for every patient using these tools.

Anil Parwani, MD, PhD, explains his visions and plans for further development and integration of artificial intelligence technology in cancer diagnosis and prognosis.


Recent Updates in PEACE-3 Trial Presented at ESMO 2024

Panelists discuss how the CONTACT-02 study results reveal final overall survival data for patients with liver or bone metastases, providing crucial insights into treatment efficacy for these specific metastatic sites.

Video Series

ESMO 2024 Trial Updates: Contact-02

Panelists discuss how the EORTC-GUCG 1333 (PEACE-3) trial, presented at ESMO 2024, illuminates key findings regarding the study population and primary endpoints in genitourinary cancer research.

Exploring Updates in TiNivo-2 From ESMO 2024

Panelists discuss how the combination of Tivozanib plus Nivolumab from the TiNivo-2 study, along with other data presented at ESMO 2024, shows potential for improving outcomes in certain cancer treatments.

ESMO 2024: Updates in NIAGARA Study

Panelists discuss how overall survival and event-free survival data presented at ESMO 2024 demonstrate promising outcomes in cancer treatment.

Can Targeted Therapy Revolutionize MIBC Treatment?

The phase 2 SunRISe-4 study (NCT04919512) evaluated the efficacy and safety of neoadjuvant TAR-200 and cetrelimab, an anti–PD-1 agent, in patients with muscle-invasive bladder cancer (MIBC).

The study found that patients receiving TAR-200 and cetrelimab had significantly higher rates of pathologic complete response (pCR) compared to those receiving cetrelimab alone. Additionally, the safety profile of TAR-200 and cetrelimab was manageable. These results suggest that TAR-200 may be a promising treatment option for patients with MIBC, particularly those with early-stage disease.

Here, Andrea Necchi, MD, associate professor of oncology at Vita-Salute San Rafaelle University and director of genitourinary oncology at San Raffaele Hospital in Milan, Italy, discusses how these findings build upon others from the SunRISe series of clinical trials. 

The SunRISe platform is testing TAR-200 in different disease settings, non–muscle-invasive disease, and we have already pretty well positioned in getting a potential new therapeutic option there for [Bacillus Calmette-Guerin (BCG)]-uresponsive tumors in patient with muscle-invasive disease. The point here is how to best manage the future patients with regards to the potential of curing patients and avoiding the radical surgery, cystectomy. It is quite highly impactful for that, for the patients, and quite impactful for the healthcare system, for the cost and the management of the patients in general. 

So the possibility of getting a cure, achieving a cure for the patient side with the combination, with a newer combination, and potentially also avoiding radical cystectomy that is also affecting the quality of life of the patients is is a major step, is a potential major step for further research in these patients.

Andrea Necchi, MD, discusses how the findings from SunRISe-4 impact other data from the SunRISe group of clinical trials. 

Conference News

Following a discussion centered on the EV-302 study, Thomas Powles, MBBS, MRCP, MD, and the Oncology Brothers discuss the role of ctDNA in urothelial cancer.

The Role of Circulating Tumor DNA in Bladder Cancer

Following a discussion centered on the EV-302 study, Thomas Powles, MBBS, MRCP, MD, and the Oncology Brothers discuss the role of circulating tumor DNA in urothelial cancer.

Bladder Cancer

Latest News