Clinical Trial News

KEYTRUDA plus LENVIMA with TACE reduced disease progression risk by 34% in Phase 3 LEAP-012 trial for unresectable, non-metastatic HCC, with PFS of 14.6 months vs. 10.0 months for TACE alone. OS showed a trend toward improvement but was not statistically significant.

KEYNOTE-A18, a Phase 3 trial, showed KEYTRUDA (pembrolizumab) plus concurrent chemoradiotherapy (CRT) improved overall survival (OS) in high-risk locally advanced cervical cancer patients, reducing the risk of death by 33% compared to CRT alone. The results were presented at the ESMO Congress 2024 and published in The Lancet.

NIKTIMVO™ (axatilimab), a first-in-class anti-CSF-1R antibody, treats chronic graft-versus-host disease (cGvHD) in adults and pediatric patients weighing ≥40kg with at least two failed systemic therapies. FDA approved in August 2024, NIKTIMVO targets inflammation and fibrosis drivers in cGvHD, supplied as a 50mg/ml solution in single-dose vials for IV administration. Clinical trial AGAVE-201 showed 75% ORR within six months, with sustained response in 60% at 12 months.

Pfizer's Phase 2 study of ponsegromab met primary endpoint, showing significant body weight increases compared to placebo across all doses, with a 5.61% mean increase at the highest dose after 12 weeks. Ponsegromab was generally safe and well-tolerated, with improvements in appetite, cachexia symptoms, physical activity, and muscle mass at the highest dose. Pfizer plans to initiate registration-enabling studies in 2025.

FDA's GIDAC discussed Intercept's sNDA for OCALIVA for PBC treatment; Intercept disappointed by the committee's vote, emphasizing OCALIVA's clinical benefits. FDA to make final decision by October 15, 2024.

ICMR formalizes MoAs with sponsors for Phase 1 trials of four molecules, partnering with Indian Immunologicals for Zika vaccine, Mynvax for seasonal flu vaccine, Aurigene Oncology for multiple myeloma, and ImmunoACT for CAR-T cell therapy in chronic lymphocytic leukaemia. The trials will be conducted across four Indian institutions, supported by a Central Coordinating Unit at ICMR Headquarters.

Jonathan Riess discussed combining IO102-IO103 cancer vaccine with pembrolizumab for advanced SCCHN, presenting a 44.4% partial response rate and safety data at ESMO 2024, suggesting potential for larger studies.

Experts at the Skin of Color Update discussed recent FDA approvals for dermatology treatments, emphasizing the importance of clinical trial diversity. Key approvals included roflumilast and tapinarof for psoriasis, roflumilast for seborrheic dermatitis, and roflumilast for atopic dermatitis. Additionally, biologic therapies such as bimekizumab for psoriasis, secukinumab for hidradenitis suppurativa, and nemolizumab for prurigo nodularis were highlighted. The FDA is developing a diversity action plan to ensure more inclusive clinical trials.

FDA approves Kisunla, a new drug to slow Alzheimer's progression, offering hope to millions. Dr. Ferguson emphasizes its significance in targeting dementia mechanisms. The annual Walk to End Alzheimer’s in Neenah, hosted by NBC 26’s Nina Sparano, aims to combat the disease.

FDA accepts Palatin's PL9643 Phase 3 trials for dry eye disease; optometrists' role in geographic atrophy treatment evolves; The Vision Council reports decline in practice performance; theories on autism and eye tracking explored; NovaSight's CureSight device shows efficacy in amblyopia treatment.