Hannah Clarke

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.

The UroActive System is currently under investigation in 2 first-in-human clinical trials in male and female patients with SUI.

“These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives," says Thomas Powles, MD.

A phase 1 trial of ADI-270 in clear cell RCC is expected to launch in the second half of 2024.

The fast track designation for BNT324/DB-1311 is supported by safety and efficacy data from an ongoing phase 1/2 trial of the ADC in patients with advanced/metastatic solid tumors.

Data from SEER showed a median OS of 23.0 months between the years 2000 to 2004 in patients with mHSPC, which increased to 30.0 months in 2015 to 2019.

Subcutaneous nivolumab is also under review in the United States based on findings from the phase 3 CheckMate-67T trial.

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

A novel co-formulation of bremelanotide and a PDE5 inhibitor allows the treatment to be administered to patients via a single injection.

Patients in the Cxbladder arm had a 59% relative reduction in the number of cystoscopies performed vs those in the control arm.

"This study reinforces our role as physicians to guide patients away from costly supplements with little or no benefit," said Wai Lee, MD.

The new Category I code will become effective on January 1, 2026.

Cretostimogene grenadenorepvec is an intravesical oncolytic immunotherapy currently under investigation in phase 3 trials.

"The positive trends emerging from the ongoing phase 1 trial of BMC128, particularly in combination with nivolumab, underscore the transformative potential of microbiome-based therapeutics in oncology,” says Gal Markel, MD, PhD, MBA.

The first commercial doses of the diagnostic have now been administered in both Austria and France.

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 12-month duration of response was 82.3% among patients with LG-IR-NMIBC who achieved a complete response at 3 months following the first UGN-102 instillation.

“Our trial’s preliminary major finding is that PSCA-directed CAR T cells may be effective against mCRPC," says Saul J. Priceman, PhD.

The median progression-free survival with the combination was 19.83 months.

The negative margin rate was 72.8% with UnfoldAI vs 1.6% with SOC, translating to a 45-fold increase in accurately identifying cancer extent with the AI tool.

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 ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” says Eugene Teoh, MBBS, MRCP, FRCR, DPhil.

"We concluded that to improve cost-effectiveness, prostate cancer screening strategies should focus on reducing false positives and overdiagnosis," says Roman Gulati, MS.