Hannah Clarke

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.

“The results of the BRAVO study performed within the VA health care system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a BLC compared to patients who received WLC only,” says Stephen B. Williams, MD, MBA, MS, FACS, FACHE.

Patients who received PUL experienced a greater reduction in inference regarding outdoor entertainment and community activities at 1 month vs WVTT.

"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.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

Investigators will begin setting up the TRANSFORM trial in spring 2024, with study recruitment set to begin later in the year

"Results from these trials show that giving physicians an alert informing them of their patient’s actual risk for antibiotic resistance can help them choose the best antibiotic and reduce extended-spectrum antibiotic use,” says Shruti Gohil, MD, MPH.

All patients have been successfully dosed in the first cohort of patients, and the Safety Review Committee has granted approval for progression of the study to the second dose level of INKmune.

"The results showed the contemporary Aquablation procedural safety in Japanese men is exceptional in a broad range of prostate sizes along with significant symptom reduction," says Nobuyuki Hinata, MD.

"This was a very special moment, delivering the news to this patient that his cancer is now undetectable following the treatment with 2 doses of 8 GBq of 67Cu-SAR-bisPSMA," says Luke Nordquist, MD, FACP.

The first patient was treated with TLX250-CDx at the Olivia Newton-John Cancer Wellness Centre at Austin Health in Melbourne, Australia,

Following the positive recommendation, the European Commission will now review the application for vibegron for potential approval in the OAB setting in all EU member states, as well as in Iceland, Liechtenstein, and Norway.

The clearance of the IND application for RAG-01 will initiate the launch of clinical trials in the US.

A decision regarding EU marketing authorization is expected by June 2024.

“ARO-HIF2’s ability to target cancer cells, disrupting a key tumor-driving mechanism, illustrates the potential of siRNA technology in oncology,” says James Brugarolas, MD, PhD.

“This brand new guideline offers options for all patients with OAB with a focus on shared decision-making between patients with OAB and clinicians, as well as a personalized, tailored approach to care,” said Cameron and Smith.

The approval is based on 3 clinical trials evaluating the efficacy of different pivmecillinam dosing regimens in comparison with either placebo, another oral antibacterial drug, or ibuprofen.

The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.

Both the SOLAR-STAGE and SOLAR-RECUR trials are currently enrolling patients with prostate cancer in the US, with additional sites expected to open in Europe later this year.

Findings from the study showed a clinical response rate of 76.4% and 78.4% at 6- and 12-months following activation of the device among patients in the intent-to-treat population.

The approval is supported by findings of the ongoing QUILT-3.032 trial, assessing nogapendekin alfa inbakicept (N-803) plus BCG in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

"At a time when patients are increasingly concerned about prescription drugs, this information will provide a useful starting point for making essential medications as affordable as possible," says Ruchika Talwar, MD.

"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.

"We look forward to announcing initial efficacy and safety data from the study, which we expect will be at the end of this quarter," says Salim Yazji, MD.

“This is the first study to show a statistically significant and clinically meaningful survival improvement with any adjuvant therapy in kidney cancer, and this further supports adjuvant pembrolizumab as a standard of care after surgery in this disease setting,” says Toni K. Choueiri, MD.

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.

“We are hopeful that this therapy will help patients with prostate cancer and that this study will be just the first step towards the effective treatment of other bone tumors,” said Daniel Abate-Daga, PhD.

“These findings suggest that guideline recommended treatment intensification remains low for patients with mCSPC in both Medicare and the Veterans Health Administration, but especially for Black patients,” says Daniel J. George, MD.

“In the future, this imaging technique can help to streamline the drug development process, driving conviction in the agents we bring to larger scale trials," says Stephen Rose, PhD.