Clinical Trial News

The FDA's Oncologic Drugs Advisory Committee unanimously supported minimal residual disease (MRD) as an endpoint for accelerated approval of multiple myeloma treatments, acknowledging its prognostic value for progression-free and overall survival. However, concerns were raised about MRD's limitations and the need for FDA vigilance to ensure long-term clinical efficacy.

Tyson Haller, at risk for Alzheimer's due to family history, participates in the AHEAD 3-45 study testing lecanemab, a drug aiming to prevent Alzheimer's by targeting amyloid plaques. Despite modest success in slowing disease progression, challenges remain, including high costs and side effects. The study represents hope for early intervention, with ongoing trials and debates on diagnosis and treatment efficacy.

TORL BioTherapeutics secured $158M in Series B-2 financing, led by Deep Track Capital, to advance its clinical-stage ADCs targeting CLDN 6+, CLDN 18.2+, CDH17+, and DLK1+ solid tumors. The funding supports pivotal trials for TORL-1-23 in platinum-resistant ovarian cancer and other programs, aiming to deliver breakthrough therapies for cancer patients.

Spectral Medical Inc. updates on Tigris trial, a Phase 3 study for PMX in treating endotoxemia and septic shock, with 101 patients enrolled by Q1 2024. Aiming for full enrollment of 150 patients, Spectral hosted an Investigator Meeting to support trial progress. PMX, a therapeutic device for septic shock, is under U.S. FDA review.

At the American Association for Cancer Research (AACR) Annual Meeting 2024, the Phase 1/2 LINKER-MM1 trial results for linvoseltamab, an investigational bispecific antibody, showed a high response rate in patients with relapsed/refractory multiple myeloma. The treatment facilitated early, durable responses and allowed for extended dosing intervals in a significant portion of patients.

Semaglutide, a GLP-1 receptor agonist used in diabetes and weight-loss drugs, shows heart-related benefits beyond weight loss, improving symptoms and physical limitations in heart failure patients with preserved ejection fraction and type 2 diabetes. The study highlights semaglutide's potential mechanisms beyond weight loss, including effects on inflammation and insulin resistance.

Phanes Therapeutics' PT217, a bispecific antibody targeting DLL3 and CD47, received FDA Fast Track designation for treating extensive-stage small cell lung cancer (ES-SCLC). PT217, also granted orphan drug status in 2022, is in Phase I trials for SCLC, LCNEC, and EP-NECs, aiming to improve survival rates in these aggressive cancers.

Sunvozertinib received FDA breakthrough therapy designation for first-line treatment of EGFR exon 20 insertion mutation-positive NSCLC, showing efficacy and tolerability in trials. Approved in China for similar use, it demonstrated a 78.6% ORR and 12.4 months median PFS in the WU-KONG1 trial. Safety data indicated manageable adverse effects. Global phase 3 studies are ongoing, with U.S. and EU approvals anticipated in 2024.

A study presented at AACR 2024 introduced a blood-based machine learning assay combining cfDNA fragment patterns with CA125 and HE4 protein levels to differentiate ovarian cancer from healthy controls or benign masses. This approach, achieving high specificity and accuracy, aims to improve early detection and screening paradigms for ovarian cancer, a leading cause of cancer deaths among women.

Corcept Therapeutics completed enrollment in the phase III ROSELLA study for relacorilant combined with Abraxane for recurrent, platinum-resistant ovarian cancer, expecting progression-free survival data by 2024-end. Relacorilant is also in phase III studies for Cushing’s syndrome and adrenal cancer, with data expected in 2024. Corcept's shares dropped 25.4% this year.