"While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations," says Michael P. Bailey.
here was a higher concordance of somatic alterations between tissue and ctDNA testing in patients with metastases vs those without.
ORIC-944 was initially being evaluated as a monotherapy in the phase 1b trial.
Topline results from the phase 3 ARANOTE trial showed a statistically and clinically significant improvement in rPFS with the addition of darolutamide to ADT vs ADT alone.
Data showed a 90.6% rate of correct consumer self-selection among those who used the Web App Technology with the DFL vs 57.3% among those that used the DFL alone.
“These findings provide a plausible mechanism for the enhanced clinical outcome with CBM588 now seen across 2 small, randomized trials,” write the authors.
All patients have now been enrolled in cohort 6 of the trial, and dosing with ONCT-534 has begun at the dose level of 1200 mg.
“Our findings suggest an impact of living in disadvantaged neighborhoods—which more commonly affects African Americans—on stress-related genetic pathways in the body. We believe this may increase an individual’s risk of aggressive prostate cancer and contribute to prostate cancer disparities by race,” says Kathryn Hughes Barry, PhD, MPH.
At 12-week follow-up, TAS-303 demonstrated a least squares mean percent change in SUI episode frequency per 24 hours of -57.7% vs -46.9% with placebo.
“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.
All 3 codes for the procedure will become effective on January 1, 2025.
The guideline includes 38 recommendations on managing incontinence following treatment for localized prostate cancer or benign prostatic hyperplasia.
"We believe the collective findings are unique in urogynecology and offer strong evidence that first-line incontinence treatment is effective, and women can access it using the Leva System,” says Evelyn Hall, MD.
The cisplatin drug shortage was first announced on February 10, 2023.
The phase 1b trial enrolled 51 female patients with OAB to assess the safety, tolerability, and preliminary efficacy of V117957.
There was an overall response rate of 39% among the 18 evaluable patients, including 1 complete response and 6 partial responses.
This announcement comes on the heels of an FDA acceptance of an investigational new drug application for ADI-270 in June.
MK-5684/ODM-208 is a selective CYP11A1 inhibitor currently under investigation in the phase 3 OMAHA1 and OMAHA2a trials.
In May 2024, the FDA cleared an investigational new drug application for 225Ac-FL-020.
"This clearance in the US of our new ureteroscopy solution not only demonstrates a market expansion for Ambu; it is a testament to the progressive shift towards single-use solutions within the field of urology," says Britt Meelby Jensen.
The decision is supported by findings from the phase 3 EMPOWUR trial and the phase 3 EMPOWUR extension study.
Earlier this year, the FDA cleared an investigational new drug application for SYNC-T SV-1022.
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.
CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes, and modulate the gut microbiota in beneficial ways,” says Sumanta Pal, MD.
The positive CHMP opinion is supported by findings from cohort 1 of the phase 3 THOR trial.
"The addition of efficacy data from the KEYNOTE-B61 trial reinforces the important role of KEYTRUDA plus LENVIMA as a frontline treatment option for adult patients with advanced RCC regardless of histology," says Takashi Owa, PhD.
Overall, the investigators found a median PSA level of 0.02 ng/mL among transgender women with no diagnosis of prostate cancer.
"Using this as an adjunctive test after PSA screening will give physicians more information to help decide if their patient should undergo a prostate biopsy or not,” says M. Eric Hyndman, MD, PhD, FRCSC.
“The MAT2A-Trop2 ADC combination targets 2 distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," says Darrin M. Beaupre, MD, PhD.
“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.
