Genomic Testing

“By understanding the mirSNP genetic markers that predispose patients to adverse side effects from cancer therapy we can tailor these therapies to minimize harm and maximize efficacy," says Joanne B. Weidhaas, MD, PhD, MS.

This announcement follows an earlier FDA decision to grant approval to the company’s tissue-based comprehensive genomic profiling test FoundationOne CDx for the same therapy and indication in August 2023.

The positive CHMP opinion is supported by findings from cohort 1 of the phase 3 THOR trial.

"This information, and future expansions of this work could help refine the ways in which key clinical decisions are made..." says Michael S. Leapman, MD, MHS.

“Even when we adjusted for other clinical variables, like age or grade of tumor, this signature was still independently associated with recurrence after treatment for this form of kidney cancer," says Simpa S. Salami, MD, MPH.

Patients in the Cxbladder arm had a 59% relative reduction in the number of cystoscopies performed vs those in the control arm.

Disitamab vedotin is a novel humanized anti-HER2 antibody-drug conjugate that previously demonstrated encouraging anti-tumor activity in combination with toripalimab in patients with metastatic urothelial carcinoma.

The median progression-free survival with the combination was 19.83 months.

The median OS was 14.5 months among those with high B2 expression, compared with 24.0 months among those with low B2 expression.

Benjamin L. Maughan, MD, PharmD, highlights key studies presented at the 2024 ASCO Annual Meeting regarding biomarkers and the evolution of first-line treatments in renal cell carcinoma.

"Ensuring equal access to genomic tumor testing and precision medicine treatments may be a viable strategy to help close the well-described gaps in prostate cancer outcomes between Black and White men," says Luca F. Valle, MD.

“Certainly, there are more and more radioligands coming out not only in prostate cancer, but in other cancers related to urology, and I think that's going to be the next big wave,” says Timothy A. Richardson, MD.

"Until now, no single center has had enough samples of the quality needed for comprehensive multi-omics profiling, as we’ve carried out in this study,” says Saravana Mohan M. Dhanasekaran, PhD.

Updated data from the phase 2 TAMARCK study continued to show safety and preliminary efficacy with the B7-H3–targeting antibody-drug conjugate vobramitamab duocarmazine in patients with metastatic castration-resistant prostate cancer.

High-quality imaging with [68Ga]Ga-DPI-4452, a carbonic anhydrase IX (CAIX)-targeting radiolabeled peptide, was observed by researchers as early as 15 minutes after administration.

"Our research shows that the identification of these genetic factors, even in geriatric patients, is important for determining targeted treatment and overall patient survival,” says Mahdi Taha, DO, FACOI, FACP.

“This data emphasizes the importance of utilizing the EPI test for risk assessment of high-risk prostate cancer in [African American] men," concluded the authors.

Rohan Garje, MD, discusses precision medicine in metastatic prostate cancer, including genomic testing, targeted therapies, and theragnostics.

"[This] shows a different approach for detecting circulating tumor DNA in bladder cancer patients, and it opens up the possibility for other biorepositories that have serum samples to also enter the ctDNA research environment," says Richard T. Bryan, MBChB, PhD, MRCS, FacadTM.

"This preplanned ENACT trial biomarker analysis demonstrates the value of the Decipher score, AR-A score, and PAM50 genomic classifiers in identifying patients undergoing AS who are most likely to benefit from enzalutamide treatment," wrote the authors.

The MPS2 models demonstrated negative predictive values of 95% to 99% for cancers of grade group 2 or higher and of 99% for cancers of grade group 3 or higher.

"What we found is that over a third of patients, 36%, had positive family history of either prostate, breast, or pancreatic cancer. And if you had this type of a family history, there was nearly a two-fold risk of dying of prostate cancer in the long term," says Keyan Salari, MD, PhD.

"As a kidney cancer community, we need to investigate these molecular subtypes prospectively in clinical trials to determine whether specific subtypes benefit from certain therapies or not," says David A. Braun, MD, PhD.

The study is exploring the small activating RNA therapy RAG-01 in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

“Systemic therapy for RCC has changed very quickly. Every year, it's exciting to see that we're getting new developments, new drug approvals, and changes in the standard of care,” says Wenxin (Vincent) Xu, MD.

Rohan Garje, MD, discusses recent research linking TP53, RB1, and PTEN mutations with worse overall survival outcomes in prostate cancer.

“The MODERN trial represents a step towards precision medicine in bladder cancer treatment," says Matthew D. Galsky, MD.

The novel agent ABSK061 approached a response rate of 40% in patients with advanced solid tumors harboring FGFR2/3 alterations.

The AssureMDx test demonstrated an area under the curve of 0.80 in detecting urinary tract recurrences in MIBC.

“So, my take home message for the urology community is even if you're not doing clinical trials, we already have FDA-approved, CMS-covered, most commercial insurances-covered genetic alterations now for our CRPC populations, and there will be more to come,” says Neal D. Shore, MD, FACS.