Hannah Clarke

The BLA submission is supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of TLX250-CDx for PET/CT imaging of ccRCC.

Data from a phase 1 study of KPG-121 were also recently presented at the 2024 ASCO Annual Meeting.

The study reported a median rPFS of 8.8 months among 23 adult patients with previously treated, progressive mCRPC.

"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.

The change was made following the submission of a real-world evidence study showing that 5- to 10-year overall survival following robot-assisted radical prostatectomy was comparable to that of non-robotic radical prostatectomy.

"We hope this study encourages a national acceptance of active surveillance as an effective management strategy for prostate cancer,” says Daniel Lin, MD.

No statistically significant difference was seen in progression-free survival among those who received metformin vs those who received placebo.

“The PRO data presented here complements the published clinical efficacy and safety data, add the patient's voice, and support the use of EV/pembro for patients with locally advanced/metastatic urothelial cancer," says Shilpa Gupta, MD.

"In the cisplatin-ineligible cohorts, we showed that high event-free survival and overall survival rates can be achieved at 12 and 36 months in patients treated with neoadjuvant avelumab in combination with cisplatin-based chemotherapy," says Jeremy Blanc, MD.

Gilead reported that a numerical improvement in OS favoring sacituzumab govitecan was observed, though the end point was not reached in the intent-to-treat population.

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).

The IND acceptance will initiate the launch of a phase 1 trial to evaluate the safety, tolerability, and preliminary anti-tumor activity of 225Ac-FL-020 in patients with mCRPC.

"This announcement is an important step in increasing the awareness and accessibility of OnQ Prostate beyond its earliest adopters, so that more physicians and patients can benefit from this technology," says Brittany Hunt.

The approval is based on findings from the phase 3 CheckMate-901 study.

Regarding patient-reported outcomes, those who underwent URS showed higher urinary symptoms, greater pain intensity, and greater pain interference at 1 week following surgery compared with those who underwent SWL.

“If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival," says Mike Crosby.

The predictive models identified the number of previous UTI episodes, prior β-lactam nonsusceptibility, prior fluoroquinolone treatment, Census Bureau region (particularly in the South), and race as key predictors of having a non-susceptible isolate to 3 or more antibiotic classes.

Among the 3 CD70-positive patients, the ORR was 66.7%, with 2 patients achieving a partial response.

"Since the phase 2 data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following phase 3 pivotal trial design has been discussed with the US FDA and the approval for the protocol has been received this month," said Yong Yue, MD, PhD.

The first-in-human study expects to begin dosing patients with DF9001 in combination with pembrolizumab in Q4 of 2024.

"When thinking about living with prostate cancer, this is really a couples' disease, and partners' unmet needs should be part of the conversation," says Stacy Loeb, MD.

Preliminary results from the CUPID study were based on data from 11 evaluable patients with advanced prostate cancer.

RAG-01 is an saRNA therapy that is delivered via intravesical instillation and is designed to target and activate p21, a tumor suppressor gene.

"We were deeply impressed by Galen's performance in the study, that based on our validation, clearly showed how Ibex can support our clinicians in improving diagnostic quality and efficiency, and as a result we have decided to implement it routinely,” says Junya Fukuoka, MD, PhD.

Yōni.Fit is a soft vaginal insert intended to reduce urine leakage due to SUI without interfering with voluntary urination.

"Prolaris precisely describes the difference in metastasis outcomes for men receiving monotherapy (RT) vs multimodal therapy (RT+ADT), and further tells me precisely what the risk of death is for a man on surveillance," says Jonathan D. Tward, MD, PhD.

"225Ac-PSMA-Trillium is a novel approach, which could provide a new treatment to address this unmet need in mCRPC,” says Fred Saad, MD, FRCS.

The dose escalation/dose expansion study is evaluating the safety and efficacy of AB-2100 in patients with ccRCC who either came back or did not improve following prior treatment with a checkpoint inhibitor and a VEGF inhibitor.

“The association of lower testosterone concentrations with higher all-cause mortality was present irrespective of luteinizing hormone concentrations, indicating that low testosterone was the main factor," says Bu B. Yeap, MBBS, FRACP, PhD.

The Contouring Assistant now marks Profound Medical’s second FDA-cleared TULSA-AI module.