Bladder Cancer

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population ≥10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

In an interview with&nbsp;<em>Targeted Oncology</em>, Paul L. Crispen, MD, discussed several ongoing trials for patients with bladder cancer focused on the importance of bladder preservation. He also highlighted a clinical trial currently enrolling at the University of Florida Health for patients with upper tract disease.

Shilpa Gupta, MD, discusses the current role of immunotherapy in treating patients with bladder cancer and how biomarkers have become an unmet need.

The recent approval of erdafitinib has significant implications for the field, says Arjun V. Balar, MD. It marks the most recent in a string of FDA approvals in urothelial carcinoma after nearly 3 decades of little to no advancement but is, importantly, the first targeted therapy in UC, which should open the door for more biomarker-driven drug discovery.

According to data from the phase II EV-201 study presented at the 2019 ASCO Annual Meeting, 44% of patients with locally advanced or metastatic urothelial cancer achieved responses with enfortumab vedotin. This includes 12% of patients reached a complete response to treatment.&nbsp;Median overall survival time for patients was 11.7 months.

Arjun V. Balar, MD,&nbsp;highlights the KEYNOTE-057 study findings and provides insight into the role of immunotherapy in bladder cancer.

The FDA has granted P-BCMA-101 with an orphan drug designation for the treatment of patients with relapsed and/or refractory multiple myeloma.

Vofatamab when given as a monotherapy or in combination with docetaxel was well tolerated and had no long-term safety issues in 55 patients with metastatic urothelial cancer who had failed platinum-based chemotherapy, according to the results of a phase II expansion study.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;April 2019, including several new approvals, a priority review, breakthrough designation, and more.

Arjun V. Balar, MD, discusses key findings from updated data from the interim analysis of KEYNOTE-057, a phase II single-arm trial of pembrolizumab (Keytruda) in Bacillus Calmette-Gue&#769;rin-unresponsive, high-risk nonmuscle-invasive bladder cancer, which he presented during the&nbsp;the 2019 Genitourinary Cancers Symposium.

The immune checkpoint inhibitor pembrolizumab continued to demonstrate encouraging antitumor activity in an interim analysis of KEYNOTE-057, which involved a subset of 102 patients with nonmuscle-invasive bladder cancer.

Erdafitinib (Balversa) has been granted an accelerated approval by the FDA as a treatment for&nbsp;adult patients with locally advanced or metastatic bladder cancer with an <em>FGFR3</em> or <em>FGFR2</em> alteration that has progressed on platinum-containing chemotherapy, making it the first targeted agent to receive approval for&nbsp;metastatic bladder cancer.

A discussion between&nbsp;regulators and special interest groups has cooled some of the excitement generated by the emergence of chimeric antigen receptor T-cell therapy for treating hematologic cancers.

Before a community oncology practice considers getting involved in clinical trials research, there are many factorsto consider. Perhaps foremost is the fact that cancer clinical trials provide the evidence base for new advances in oncology.&nbsp;

Artificial intelligence has made inroads in many industries&mdash;banking, finance, security&mdash;but its adoption in healthcare has been lagging and real-world clinical implementation has yet to become a reality. Nonetheless, proponents say it is only a matter of time and pilot programs are starting to yield some practical results.&nbsp;

The success of chimeric antigen receptor T-cell therapy observed in hematologic malignancies has not yet translated into the solid tumor setting; however, efforts continue to try to bring this new modality into the treatment paradigm for solid tumors, including pancreatic cancer.&nbsp;

Positive findings have been seen with a novel antibody&ndash;drug conjugate in a pivotal trial for patients with advanced or metastatic urothelial cancer who have previously been treated with immunotherapy and chemotherapy, according to an announcement from the co-manufacturers Seattle Genetics and Astellas Pharma.

Thomas W. Flaig, MD,&nbsp;discusses the latest updates to the NCCN guidelines for the treatment of patients with muscle-invasive bladder cancer. In addition, he highlights the latest approvals of checkpoint inhibitors in this patient population.

The healthcare community is still awaiting a response from the Centers for Medicare &amp; Medicaid Services to the opposition of the agency&rsquo;s proposal to substantially revise the Medicare Part D protected drug classes.