Jordyn Sava

MT-303, a novel GPC3-targeting mRNA/lipid nanoparticle chimeric antigen receptor therapy, enhances cytokine-driven immune response and tumor cytotoxicity.

The FDA granted fast track designation to NX-5948 for treating relapsed/refractory Waldenström macroglobulinemia after 2 or more lines of therapy, including a BTK inhibitor.

In an interview with Targeted Oncology, Adrienne Waks, MD, provided insights into the significance of the findings from the DAPHNe trial and their clinical implications for patients with HER2-positive breast cancer.

The FDA has granted ensartinib approval for adult patients with ALK-positive non–small cell lung cancer.

The FDA issued a complete response letter for the BLA submission of subcutaneous amivantamab for EGFR-mutated NSCLC, citing manufacturing inspection issues, but confirming no need for additional clinical trials.

In an interview with Targeted Oncology, Jaime Merchan, MD, delved into data from the LITESPARK-013 trial evaluating belzutifan for advanced clear cell renal cell carcinoma treatment.

The FDA granted breakthrough therapy designation to sacituzumab govitecan for patients with ES-SCLC progressing on platinum chemotherapy, supported by promising antitumor activity in the phase 2 TROPiCS-03 study.

Positive topline data from a phase 2 trial show HT-6184, an allosteric NEK7/NLRP3 inflammasome inhibitor, improves hematologic response in lower-risk MDS.

Data from the phase 1 Acclaim-3 trial of quaratusugene ozeplasmid plus atezolizumab in extensive-stage small cell lung cancer showed no dose-limiting toxicities, with the recommended dose set at 0.12 mg/kg for phase 2.

Here are some of the highlights from this year's 2024 ASH Annual Meeting & Exposition.

The FDA granted breakthrough therapy designation to dostarlimab for locally advanced dMMR/MSI-H rectal cancer, highlighting its 100% clinical complete response rate in a phase 2 study.

The NCCN has endorsed the Prolaris prostate cancer prognostic test, reinforcing its position as a critical tool in prostate cancer prognostication.

Cosibelimab is now FDA approved for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma that is not eligible for curative surgery or radiation.

Doris K. Hansen, MD, discussed a comprehensive analysis of pretreatment biomarkers associated with outcomes in patients receiving idecabtagene vicleucel therapy

Project EVOLVE findings show how AI-driven real-world data analysis, combined with targeted educational interventions, can enhance adverse event monitoring and improve patient outcomes for those with HER2+ breast cancer.

Real-world data suggest optimal CLL/SLL treatment sequencing involves targeted therapies, including covalent BTKis and BCL2 inhibitors, for better survival outcomes.

An exploratory analysis of the KEYNOTE-522 study presented at the 2024 San Antonio Breast Cancer Symposium highlights predictive biomarkers for improved triple-negative breast cancer outcomes.

In an interview, Palak Dave discussed how artificial intelligence, using deep learning to analyze bone marrow aspirate smear images, could standardize and accelerate the diagnosis of MDS vs pre-MDS conditions.

Cilta-cel improved minimal residual disease negativity in lenalidomide-refractory multiple myeloma vs standard care, per CARTITUDE-4 results.

A phase 3 trial of uproleselan in relapsed/refractory acute myeloid leukemia failed to meet the primary overall survival end point but showed a benefit in primary refractory patients.

Zanidatamab is now a category 2A treatment for HER2-positive biliary tract cancer in the NCCN guidelines, following its FDA approval.

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

In an interview with Targeted OncologyT, Rupesh Kotecha, MD, discussed a study focused on how systemic therapy selection impacts outcomes in patients with brain metastases, particularly those with lung cancer.

The FDA has accepted an sBLA for glofitamab plus gemcitabine and oxaliplatin in relapsed/refractory diffuse large B-cell lymphoma.

CRB-701 has gained FDA fast track status for the treatment of adult patients with relapsed/refractory metastatic cervical cancer.

With this approval, zenocutuzumab is the first FDA-approved therapy for patients with NRG1 fusion tumors.

The FDA granted breakthrough therapy status to sacituzumab tirumotecan in EGFR-mutated advanced non–small cell lung cancer.

Sonodynamic therapy doubled the median overall survival to 15.7 months and tripled progression-free survival to 5.5 months in recurrent gliomas, according to a phase 1/2 trial.

Enrollment in cohort 5 of the phase 1/2 GOBLET study will resume after the Data Safety Monitoring Board’s safety review.

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the CEPHEUS trial results and impact on frontline treatment in transplant-ineligible patients with newly diagnosed multiple myeloma.