Roman Fabbricatore

Support for the decision follows phase 1 findings evaluating IBI363 in patients with advanced solid tumors presented at the 2024 ESMO Plenary.

“I don't think [the CRL] impacts how I look at the data that is publicly available and the approval chances long term for linvoseltamab and how we might use it in the future,” said Surbhi Sidana, MD.

Favorable recurrence-free survival and overall survival outcomes were not observed in the overall patient cohort receiving adjuvant chemotherapy for advanced NSCLC.

The OPHELIA trial assessed the efficacy and safety of olaparib plus trastuzumab in HER2-positive advanced breast cancer with germinal BRCA mutations.

A clinical trial evaluated the ability of oxygen-enhanced MRI-derived hypoxic volume to detect radiotherapy-induced hypoxia modification.

Regardless of T790M status, lazertinib hindered the progression of intracranial metastases after unsuccessful EGFR TKI treatment in patients with EGFR-mutated NSCLC.

The decision follows phase 3 EV-302 trial findings showing improved survival with enfortumab vedotin plus pembrolizumab vs chemotherapy in urothelial cancer.

The EGFR-MET bispecific antibody amivantamab in combination with chemotherapy yielded a survival benefit compared with chemotherapy alone for EGFR-mutated NSCLC.

Preliminary results from part 2 of the phase 2 trial evaluating VP-315 in basal cell carcinoma found no dose-limiting toxicities or treatment-related serious adverse events.

The PREFERABLE-EFFECT study found that supervised resistance and aerobic exercise were associated with reduced fatigue in patients with metastatic breast cancer.

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.