Roman Fabbricatore

Supporting data for the designation comes from the ARTEMIS-001 trial evaluating preliminary safety and antitumor activity of GSK’227 in solid tumors.

PAX8, a marker for aggressive disease in numerous cancer types, was more highly expressed in Black patients with uterine serous carcinoma.

The phase 1/2 LINKER-MM1 trial assessed linvoseltamab in relapsed/refractory multiple myeloma, of which the indication has been given a CRL by the FDA.

Further development of vebreltinib in patients with MET fusions is being considered following results from the phase 2 SPARTA trial.

“The dMMR population, which are patients who have deficiency in their mismatch repair proteins, had the most pronounced impact in PFS, and we’re seeing that trend for prolonged periods of time; we may be curing many of these patients,” said Ritu Salani, MD.

Phase 1/2 AUGMENT-101 study results revealed quick and lasting responses for patients with relapsed/refractory KMT2Ar acute leukemia.

Phase 1 AC699-001 results evaluating the safety and efficacy of AC699 in patients with breast cancer subtypes support the Fast Track designation.

Investigators developed a risk model to assess whether upfront surgery can improve prognoses in a subset of cN2 diseases such as single-station N2 NSCLC.

CytoDyn intends to submit its final study protocol to the FDA, engage a clinical research organization, and complete preparatory work to initiate the phase 2 trial.

Findings from a population-based study suggest patients with POI may need genetic counseling regarding future risk of reproductive cancers.

Neoadjuvant/adjuvant sacituzumab govitecan showed encouraging intratumoral concentrations in patients with brain metastases as well as glioblastoma.

Investigators will present full results from the phase 3 GMMG-HD7 trial at a future medical meeting.

Managing high-grade squamous intraepithelial lesions may reduce the risk of anal cancer based on data from the phase 3 ANCHOR trial.

Reduction of long-term survival following CAR T-cell therapy associated with late infections and SMN development was observed, especially in elderly patients.

NSABP B-42 trial results show that the assay was predictive of extended letrozole therapy response, identifying a patient subset with improved outcomes.

Retrospective analysis found that cryoablation was associated with infrequent AEs and low recurrence rates among patients with breast cancer.

FDA acceptance is based on phase 3 CABINET trial results, with cabozantinib showing a PFS improvement in patients with pancreatic neuroendocrine tumors.

The combination therapy was well tolerated and had a safety profile consistent with pembrolizumab monotherapy, while no new safety concerns were identified.

A holistic integration of time series and static data present in the learning approach can lead to improved understanding of breast cancer outcomes.

Results from the LUMINOSITY trial show an enriched overall response rate for telisotuzumab vedotin among patients with c-Met high overexpressing tumors.

The FDA has advised developers to attain overall survival benefit in a randomized head-to-head trial to support a BLA filing for Iomab-B.

The mean number of palliative care visits was nearly halved for stepped-palliative care vs early palliative care in patients with advanced lung cancer.

An overall survival and 3-year relapse-free survival advantage was seen with blinatumomab vs chemotherapy alone in a phase 3 trial of B-cell precursor subtype ALL.

In terms of cancer detected per 1000 MRI exams, the AI scoring method was close to 4 times more efficient vs traditional breast density measures.

New guidelines for both cancer types provide detailed and distinct criteria for diagnoses, staging, use of IGRST, and follow up, among other areas.

Complete responses were numerically higher without significance in standard triple antiemetic therapy with olanzapine vs placebo.

SP-1-303’s ATM-activating and HDAC-inhibiting properties may overcome limitations seen in prior attempts to combine therapeutic agents and HDAC inhibitors.

The safety profile of entrectinib with liquid biopsy in the BFAST study was consistent with prior reports for patients with ROS1-positive NSCLC.

The phase 3 EVOKE-01 study found that OS improved numerically, but not statistically significantly, in sacituzumab govitecan vs docetaxel with a similar safety profile.

Genetic testing may be beneficial post-cancer diagnosis for reducing cancer risk for families with hereditary cancer syndromes and managing treatment.