Clinical Trial News

The CheckMate 8HW trial showed nivolumab plus ipilimumab significantly reduced disease progression or death risk by 79% in MSI-H/dMMR metastatic colorectal cancer patients, compared to chemotherapy. With a 24-month progression-free survival rate of 72% vs 14%, and fewer severe adverse events, this immunotherapy combination may offer a new first-line treatment option.

Jacobio Pharmaceuticals presented glecirasib's efficacy in treating KRAS G12C mutated pancreatic and other solid tumors at ASCO GI 2024. With a 48% cORR and 90% DCR in evaluable patients, glecirasib shows promise over standard treatments, supported by safety and tolerability data. It received BTD for pancreatic cancer, aiming to expedite its development and patient access.

PeproMene Bio, Inc. announced a patient in their Phase 1 trial for PMB-CT01 (BAFFR-CAR T Cells) achieved complete remission post-treatment for relapsed/refractory B-cell acute lymphoblastic leukemia. The trial, conducted at City of Hope, showed minimal toxicity and durable remissions, highlighting PMB-CT01's potential in treating B-cell malignancies.

Early HIV treatment within four weeks of infection may enable long-term virus control without medication, a study shows. Starting ART early optimizes immune cells' development, enhancing natural virus elimination. Delayed treatment reduces these benefits. Despite decreasing HIV infections and AIDS mortality in Europe, scaling up testing and treatment is crucial to meet 2030 AIDS epidemic targets.

Faricimab demonstrated good visual stability and allowed for extended treatment intervals in patients with neovascular age-related macular degeneration, as per real-world data from the FARETINA-AMD study presented at Retina 2024.

MAIA Biotechnology reports positive Phase 2 trial results for THIO in NSCLC, showing unprecedented disease control rates. The company outlines 2024 milestones, including advancing THIO-101 trial and developing next-gen telomere-targeting agents. THIO, a first-in-class telomere-targeting agent, is in clinical development for NSCLC, with promising efficacy and safety data.

Nurix Therapeutics' NX-5948, a BTK degrader, received FDA Fast Track designation for treating r/r CLL/SLL after positive Phase 1 data. The drug showed clinical benefits and was well-tolerated in trials, with plans to accelerate enrollment for a pivotal study.

The FDA approved Casgevy, a CRISPR-based therapy by Vertex Pharmaceuticals and CRISPR Therapeutics, for treating transfusion-dependent beta thalassemia, following its approval for sickle cell disease. Casgevy modifies patients' blood cells to increase hemoglobin production, with common side effects including mouth sores and fever. Vertex is establishing treatment centers across the U.S. for its administration.

Axicabtagene ciloleucel (axi-cel) shows promise as a second-line therapy for relapsed/refractory large B-cell lymphoma, with a 71% complete metabolic response at 3 months and manageable safety. The phase 2 study highlights its efficacy and safety, with ongoing evaluations of secondary endpoints and quality of life impacts.

Eisai announced the Scientific Advisory Group (SAG) will discuss lecanemab's Marketing Authorisation Application (MAA) in the EU, with a decision expected in Q2 2024. Lecanemab, developed with BioArctic, is a treatment for Alzheimer's, approved in the US, Japan, and China. BioArctic plans to commercialize lecanemab in the Nordic region with Eisai.