Clinical Trial News

Dr. Jay Sarthy aims to develop less toxic chemotherapy for high-risk leukemia, using aclarubicin, a promising but unpatentable anthracycline widely used in Asia. His lab's findings suggest aclarubicin is more effective and safer than doxorubicin, with potential to reduce long-term side effects. Sarthy plans FDA registration and clinical trials, needing philanthropic support due to lack of industry investment.

FDA warns of rare, serious liver injuries from fezolinetant (Veozah), updating prescribing info to include monthly liver blood tests for 2 months after initiation, then at months 3, 6, and 9, and advising immediate discontinuation at signs of liver injury.

Nuvation Bio announced positive pooled data from Phase 2 TRUST-I and TRUST-II studies on taletrectinib, a next-gen ROS1 TKI, to be presented at ESMO 2024. The analysis highlights taletrectinib's efficacy and safety, with median duration of response at 44 months and progression-free survival at 46 months in TKI-naive patients. The data supports Nuvation Bio's planned NDA submission in the U.S., with taletrectinib granted Orphan Drug and Breakthrough Therapy Designations by the U.S. FDA and China's NMPA for ROS1+ NSCLC treatment.

Junmin Song compared BCMA treatments for multiple myeloma at ESMO Congress 2024, finding CAR T-cell therapies (ide-cel, cilta-cel) improved overall survival over bispecific antibody teclistamab. CAR T-cell therapy showed lower mortality rates and higher risk of cytokine release syndrome. Older, transplant-ineligible patients benefited more from CAR T-cell therapy.

Immunocore Holdings plc (NASDAQ: IMCR) develops TCR bispecific immunotherapies for cancer, infectious, and autoimmune diseases using its ImmTAC platform. Notable products include KIMMTRAK for metastatic uveal melanoma. Recent collaborations include a Phase 3 trial with Bristol Myers Squibb for advanced cutaneous melanoma. The company's pipeline includes programs for HBV and solid tumors, with a mission to improve patient outcomes.

Luveltamab tazevibulin (luvelta) + bevacizumab (15 mg/kg) every 3 weeks showed 56% ORR in late-stage ovarian cancer, selected as RP2D. Preliminary antitumor activity (35% ORR) observed across dose ranges. Expansion at RP2D ongoing with 23 additional patients; initial data expected H1 2025. No new safety signals detected.

Acrivon Therapeutics reports 62.5% confirmed ORR in OncoSignature-positive endometrial cancer patients from ACR-368 Phase 2 trial, with significant responder segregation (p=0.009) and median duration of response not yet reached (~6 months). FDA clears IND for ACR-2316, with first-in-human dosing expected Q4 2024. AP3 Interactome platform generates proprietary insights for drug development.

FDA actions in August 2024, Long COVID's neurological impact, smoldering MS disease progression, DAAE Score for MS progression prediction, and SCN8A-related disorder comorbidities discussed.

Repare Therapeutics to present TRESR trial data on camonsertib monotherapy at ESMO Congress on Sept 14. The Phase 1/2 study aims to establish the recommended Phase 2 dose and evaluate safety, pharmacokinetics, and preliminary anti-tumor activity in patients with solid tumors.

PRT3789, a first-in-class SMARCA2 degrader, shows encouraging anti-tumor activity in SMARCA4-mutated NSCLC and esophageal cancer patients, with generally well-tolerated doses and no dose-limiting toxicities. The study, presented at ESMO 2024, includes 65 safety evaluable patients, with 7 showing tumor shrinkage. PRT3789 is designed to treat SMARCA4 mutation-carrying cancers, which have a poor prognosis.