Clinical Trial News

Darolutamide plus androgen-deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) by 46% versus placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), with consistent benefits across subgroups and a favorable safety profile.

Qatar University scientists developed Apabetalone, an epigenetic therapy targeting gene regulation for treating chronic diseases, granted FDA breakthrough designation. Led by Dr. Zaid al-Ma'ayah, the study, published in Pharmacology and Translational Science, explores Apabetalone's potential in cardiovascular, renal, neurological, viral, and cancer disorders, funded by QU.

Pei-Yu Chen, PhD, promoted to senior research scientist (cardiovascular medicine) in 2022, focuses on TGFβ family, linked to rare and common diseases. Chen co-founded VasoRx, developing a lipid nanoparticle drug delivery system for safer, targeted drug release, aiming for human clinical trials soon.

Inavolisib (GDC-0077) showed a favorable safety profile and disease control rates of 60% at week 8 and 32% at week 16 in patients with refractory, PIK3CA-mutated solid tumors, according to the phase 2 CRAFT trial. The median progression-free survival was 3.52 months, and the 12-month overall survival rate was 51%. The most common PIK3CA mutations were E545K, E542K, and H1047R/L, with 7 patients achieving disease control at week 16. Adverse effects included hyperglycemia, diarrhea, fatigue, and constipation, mostly at grade 1 or 2.

Tecovirimat prescribed to over 7,100 US mpox patients (2022-2023) for rash and pain, with most SAEs in immune-compromised patients. Skin and anogenital regions most affected. 223 SAEs (3.1%) and 40 deaths (0.6%) reported, mainly in severely immunocompromised. HIV patients with low CD4 counts had poor outcomes. EA-IND data insufficient; controlled trials needed.

Biotronik's Selectra 3D catheter and Solia S lead receive FDA approval for left bundle branch area pacing (LBBAP), used in over 80,000 patients globally. BIO-CONDUCT trial results show high implant success (95.7%) and low complications (1.7%) at 3 months.

Angeles Alvarez Secord, MD, presented promising data on mirvetuximab soravtansine (MIRV) for platinum-sensitive ovarian cancer (PROC) at the European Society for Medical Oncology meeting. The Phase II PICCOLO trial showed a 51.9% overall response rate, with effects lasting 8.25 months. MIRV, an antibody-drug conjugate targeting folate receptor alpha (FRα), offers a less toxic alternative to platinum-based chemotherapy, especially for patients previously treated with PARP inhibitors. The drug is FDA-approved in the U.S. and under evaluation in Europe.

AMG 193, an MTA-cooperative PRMT5 inhibitor, showed responses in patients with MTAP-deleted solid tumors, with an acceptable safety profile. The phase 1 trial results, presented at the 2024 ESMO Congress, revealed partial responses and stable disease across various tumor types, including NSCLC, pancreatic ductal adenocarcinoma, biliary tract cancer, and esophageal/gastric cancer. AMG 193 targets MTAP-deleted tumors selectively, avoiding normal cells, and preliminary data suggest potential for delayed responses and clinical benefit beyond partial responses.

An antibody-drug conjugate, T-DXd, shows 'impressive' activity against HER2-positive breast cancer with brain metastases, according to the DESTINY-Breast 12 trial. Median progression-free survival was 17.3 months for patients with brain metastases, with 61.6% achieving 12-month PFS and 71% showing intracranial objective response. Side effects were consistent with previous studies, emphasizing the need for monitoring.

FDA approves Apple Watch sleep apnea detection feature, enabling its inclusion in Apple Watch Series 10, Series 9, and Ultra 2, rolling out in September to over 150 countries.