Genomic Testing

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.

“Maybe the most important [finding] is that urinary tumor DNA does seem to be a good tool for detecting residual disease within this patient population,” says Joshua Linscott, MD, PhD.

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.

"It's really interesting to see how potentially these differentially expressed genes could suggest a different biology based on the zone that they arose from," says Zeyad Schwen, MD.

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

“The first one [is] we confirmed the prognostic value of KIM-1. Overall, in INmotion010, patients with high KIM-1 clearly had a higher risk of recurrence,” says Laurence Albiges, MD, PhD.

“We are trying to evaluate the ctDNA role in prognostication as well,” says Chinmay Jani, MD.

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.

"We saw that Black men within this cohort had lower Decipher scores across all ages and Gleason scores different than what had been reported in other data sets, which was interesting," says Samuel L. Washington III, MD, MAS.

"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.

"I think the greatest implication the study has is that it tells us that family history and germline genetics independently provide complementary information that's important for risk stratification of localized prostate cancer," says Keyan Salari, MD, PhD.