Hannah Clarke

The IND will initiate the launch of a phase 3 study to explore the safety and efficacy of UGN-103 in patients with low-grade, intermediate-risk NMIBC.

Since piflufolastat (18F) was granted marketing authorization by the European Commission in July 2023, doses have been commercially sold in Greece, Italy, and the Netherlands.

Data showed that 87.8% of treated patients and 96.1% of patients who completed the study achieved normal 24-hour mean plasma testosterone values (222 to 800 ng/dL) at 90-day follow-up.

"The new results show that the 3-step method now used produces fewer insignificant cancer diagnoses than PSA screening,” says Anssi Auvinen, MD, PhD.

The approval is based on findings from the phase 3 RENOTORCH trial, which showed that toripalimab plus axitinib prolonged progression-free survival and improved the objective response rate in patients with advanced RCC compared with sunitinib.

“Our trial presents the first and the longest durable response we have seen with an allogeneic, off-the-shelf, CAR T cell therapy in the treatment of refractory solid tumors," says Samer A. Srour, MB ChB, MS.

Data showed an increase in participant knowledge in 5 of the 10 items on the Prostate Cancer Knowledge Scale and a decrease in all 10 items on the Decisional Conflict Scale after watching the video.

"This encouraging anti-tumor activity coupled with a favorable safety profile and mode of administration that is both convenient and familiar to urologists indicates that, if confirmed in future studies, TARA-002 could potentially play a meaningful role in NMIBC treatment in the future," says Timothy D. Lyon, MD.

Overall survival was 100% at 12 months and 98% at 18 months among patients with MIBC who remained ctDNA-negative on serial monitoring.

"In this follow-up analysis of the phase 3 study, we demonstrated a sustained response to Adstiladrin treatment over 3 years, allowing more than half of the patients in the study to remain cystectomy free for at least 36 months,” says Colin P.N. Dinney, MD.

“Given that non-Hispanic Black men were 4 years younger than the non-Hispanic White men, these data suggest that microvascular dysfunction may appear earlier in non-Hispanic Black men following a prostate cancer diagnosis," says Abigayle B. Simon.

The expanded label for 177Lu-PSMA-617 would include patients with mCRPC in the pre-taxane-based chemotherapy setting.

The authors also project an 85% increase in the number of deaths from prostate cancer per year, which would bring the total number from 375,000 in 2020 to nearly 700,000 by 2040.

In the monotherapy cohort of TPST-1120, 53% of patients achieved a best response of stable disease, with 5 of those patients remaining on treatment for more than 5 months.

Among the patients who were on treatment for 12 weeks or less, treatment interruptions due to TEAEs occurred in 12.6% of patients, and discontinuations due to TEAEs occurred in 5.3% patients.

The median radiographic progression-free survival with FG-3246 in mCRPC was 8.7 months.

Convergent plans to conduct phase 2 clinical trials of 225Ac-J591 in prostate cancer in 2024, with a registrational program set to begin in 2025.

The company plans to announce full market availability of the RenaFlex ureteroscope system at a later date.

“The UroLift 2 ATC is designed to deliver the same proven effectiveness of the UroLift System, with significant enhancements on a unified UroLift 2 platform,” says Brian Wilkins.

Acceptance of the IND application would initiate a first-in-human phase 1 dose expansion and escalation trial of CTIM-76 in patients with testicular and gynecologic cancers.

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

“The take-home message is: Don’t assume bad things if the tumor is growing during chemotherapy," says Andrew M. Davidoff, MD.

"Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC," says Sia Daneshmand, MD.

The sBLA is supported by findings from the phase 3 EV-302 trial, which showed that EV/pembrolizumab extended overall survival and progression-free survival vs platinum-based chemotherapy in patients with advanced urothelial carcinoma.

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option," says Timothy J. Daskivich, MD.

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

“These results are encouraging and suggest that circulating biomarkers may be useful in guiding the use of radium-223 therapy,” says David T. Miyamoto, MD, PhD.

Overall, participating pathologists felt that there is potential to increase diagnostic efficiency by using Ibex Prostate in a clinical setting.

Treatment with SBRT showed a minimal effect on prostate cancer-specific HRQL measures in regard to urinary incontinence domain scores, urinary irritative/obstructive domain scores, and bowel domain scores.

With the dosing of the first patient in Italy, Telix’s expanded access program for TLX250-CDx in ccRCC now includes 3 active countries, including the Netherlands and the US.