CAR T-cell therapy is a game-changing treatment, but it is not without the potential for serious adverse effects. Researchers and physicians still wonder about the incidence and prevalence of these risks.
Sabrina Serani
Sabrina Serani is the assistant managing editor for Targeted Oncology.
Articles by Sabrina Serani
Christina Henson, MD, discussed proposed guidelines for head and neck cancer imaging to improve patient outcomes and consistency across practices.
With this designation, the sponsor of APG-157 is eligible for more frequent interaction with the FDA, facilitating faster drug development and review for this neoadjuvant head and neck cancer therapy.
An independent data monitoring committee assessed that the PRECISION1 trial of nab-sirolimus in solid tumors would not meet an efficacy threshold to support the agent’s accelerated approval.
Biagio Ricciuti, MD, discussed findings from a retrospective study exploring the use of immune checkpoint inhibitors for longer than 2 years in patients with non–small cell lung cancer.
The application is supported by the phase 3 CheckMate -9DW study, and the FDA has set a target action date of April 21, 2025.
Byoung Chul Cho, MD, PhD, discussed findings from cohort C of the CHYRSALIS-2 study exploring amivantamab plus lazertinib in patients with non–small cell lung cancer with uncommon EGFR mutations.
Lazertinib and amivantamab as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer with specific EGFR mutations demonstrated superior efficacy compared with standard treatment.
The breakthrough therapy designation is supported by findings from the phase 3 DESTINY-Breast06 study comparing the antibody-drug conjugate with chemotherapy in patients with HR+/HER2-low breast cancer.
A Prescription Drug User Fee Act target action date of February 17, 2025, has been set for a decision on the vimseltinib application.
The FDA-approved regimen is for neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab in patients with resectable non–small cell lung cancer.
Findings from the phase 3 E1910 study showed that blinatumomab extended overall survival when added to chemotherapy vs chemotherapy alone in B-cell precursor acute lymphoblastic leukemia.
Durvalumab was also granted breakthrough therapy designation for the treatment of patients with limited-stage small cell lung cancer.
A phase 1b study will investigate PTM-101, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer.
Moritz Fürstenau, MD, discussed a follow-up of the GAIA/CLL13 study exploring venetoclax combinations vs chemoimmunotherapy for the treatment of chronic lymphocytic leukemia.
Selpercatinib led to high response and progression-free survival rates among patients who were treatment naive and pretreated with RET-altered thyroid cancers.
Erin E. Hahn, PhD, MPH, discussed the findings and implications of a retrospective study exploring breast cancer surveillance in pre- and post-COVID periods.
The blood-based ctDNA test delivered high rates of sensitivity and specificity with long lead times in detecting minimal residual disease in patients with colorectal cancer.
A phase 2 study found that a combination of pacritinib, sirolimus, and tacrolimus successfully suppressed pSTAT3 and Th1/Th17 cells, but failed to prevent acute graft-versus-host disease following allogeneic transplant.
Isatuximab plus VRd induction before transplant led to better progression-free survival compared with VRd alone, according to data from the GMMG-HD7 phase 3 study.
KeyVibe-008, a phase 3 study investigating the combination of vibostolimab and pembrolizumab in small cell lung cancer, did not show an improvement in overall survival.
The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.
Following voluntary withdrawal in 2014, denileukin diftitox is now available again for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.
The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.
LP-300, a novel small molecule, shows promise as a potential breakthrough treatment for advanced non–small cell lung cancer in never smokers.
Suresh S. Ramalingam, MD, discussed the practice-changing findings and implications of the phase 3 LAURA study investigating osimertinib for the treatment of patients with EGFR-mutated non–small cell lung cancer.
Gedeptin, a novel gene therapy, is entering phase 2 clinical trials to evaluate its efficacy in treating recurrent head and neck cancer.
While sacituzumab govitecan did not statistically improve overall survival vs docetaxel, there was a numerical improvement observed in patients with non–small cell lung cancer.
The FDA has granted an orphan drug designation to alemtuzumab, a chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.
IMMN-001 significantly extended overall survival in patients with advanced ovarian cancer when combined with standard chemotherapy, according to phase 2 trial results.