ICAHN School of Medicine At Mount Sinai

LEAP-012 trial showed improved PFS and ORR with lenvatinib, pembrolizumab, and TACE in intermediate-stage HCC, though OS data are still immature. The combination demonstrated a manageable safety profile, potentially making it a new standard of care.

Preliminary results from the RC48G001 Study Cohort C show a 75% response rate with disitamab vedotin plus pembrolizumab in HER2-expressing metastatic urothelial cancer, with activity in both HER2-positive and HER2-low tumors. The safety profile differs from enfortumab vedotin plus pembrolizumab, potentially distinguishing it. Dr. Galsky emphasizes the importance of HER2 and FGFR3 biomarker testing in all metastatic urothelial cancer patients, noting 60-80% of tumors express HER2, and highlights the ongoing phase III study comparing this combination to platinum-based chemotherapy.

Lenvatinib, pembrolizumab, and TACE significantly improved PFS in intermediate-stage HCC patients compared to placebo plus TACE in the LEAP-012 study, with manageable safety profiles.

Lenvatinib, pembrolizumab, and TACE significantly improved progression-free survival (PFS) for intermediate-stage hepatocellular carcinoma (HCC) patients compared to placebo and TACE, according to the phase 3 LEAP-012 study. Median PFS was 14.6 months vs. 10.0 months, with a hazard ratio of 0.66 (P = .0002). The treatment regimen showed manageable safety and no new concerns, suggesting it could be a new option for this patient group.

Mount Sinai Health System and IBM Research launch PREDiCTOR study to predict mental health outcomes using AI and behavioral data from clinical interviews, smartphones, and cognitive testing, funded by a $20 million NIMH grant.

Clinical trials for Alzheimer's drugs, like Eli Lilly's Kisunla and Eisai's Leqembi, often lack diversity, excluding racial minorities, ApoE4 homozygotes, and patients with comorbidities. This underrepresentation hampers the validation of eligibility criteria in diverse populations, necessitating new cutoffs. Challenges include socioeconomic barriers and inadequate outreach, impacting trial enrollment and patient care.

HeartSciences reported Q1 FY2025 financial results with $4.3M in cash and $5.9M in equity, and secured $1.9M in non-dilutive financing. The MyoVista Insights Platform and AI-ECG algorithm are progressing, with FDA submission targeted for H2 2025. The MyoVista® wavECG™ device's FDA 510(k) submission is on track for Q1 2025, with resolved hardware and software issues. HeartSciences aims to transform heart disease detection through AI-ECG solutions.

AI model detects intracranial hypertension using noninvasive data, potentially reducing risks of invasive procedures. Developed by Mount Sinai, it predicts brain pressure from routine ICU data, showing promise in improving patient outcomes and reducing complications.

IPGaia Inc. and Icahn School of Medicine at Mount Sinai signed an agreement on August 7, 2024, to integrate drug target leads into IPG’s drug discovery platform, aiming to develop innovative medicines and address global healthcare challenges.

Triparna Sen discusses interim analysis of IDeate-Lung01 trial, showing 12 mg/kg I-DXd dose achieved 54.8% objective response rate vs 26.1% for 8 mg/kg in extensive-stage small cell lung cancer patients. 12 mg/kg selected for further trials, though more toxicity research needed.