Clinical Trial News

Sumitomo Pharma America announces FDA approval of GEMTESA® (vibegron), the first β3 agonist for men with OAB symptoms on pharmacological therapy for BPH, available for prescription in the U.S.

Axena Health announces a feasibility study in Nigeria using the Leva® Pelvic Health System for female incontinence, supported by ArcHealth Foundation. The study aims to assess a clinic-based treatment program combining Leva technology with a home-based digital health education and pelvic floor muscle training (PFMT) program. The trial will enroll 60 women at two Nigerian hospitals to evaluate the acceptance and success of the treatment.

A double-blind, placebo-controlled clinical trial evaluated ProBC Plus (Bacillus coagulans LMG S-31876) for stress relief, immune status, lipid parameters, and vital signs. Results showed significant improvements, indicating its safety and effectiveness for overall well-being.

The CheckMate 73L study found that adding nivolumab to concurrent chemoradiation followed by nivolumab plus ipilimumab did not significantly improve progression-free survival over chemoradiation followed by durvalumab in patients with stage III NSCLC. Median PFS was 16.7 months vs 15.6 months, missing the primary endpoint. Median overall survival was 34.6 months vs 40.2 months. Objective response rates were 68% vs 64%. No new safety signals were observed, but pneumonitis increased with concurrent immunotherapy and chemoradiation.

Puma Biotechnology announced NCCN updated cervical cancer guidelines to include neratinib for HER2-mutated tumors. This addition is based on the Phase II SUMMIT trial results, offering neratinib as a second-line therapy option for patients with HER2-mutated recurrent or metastatic cervical cancer.

The U.S. FDA accepted Nuvation Bio's NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, for Priority Review, with a PDUFA goal date of June 23, 2025. The NDA is based on Phase 2 TRUST-I and TRUST-II studies showing durable responses and prolonged PFS in ROS1+ NSCLC patients. Taletrectinib could be a best-in-class treatment option for this patient population.

Puma Biotechnology announced NCCN updated cervical cancer guidelines to include neratinib monotherapy for HER2-mutated tumors, based on Phase II SUMMIT trial results.

XBiotech suspended its rheumatology program after its Phase II study of Natrunix for Rheumatoid Arthritis failed to meet the ACR20 response rate primary endpoint and revealed significant irregularities, including multiple enrollments of the same subjects at high-enrolling sites. Planned studies in arthritis and ankylosing spondylitis are now on hold.

Puma Biotechnology announced NERLYNX® inclusion in NCCN Cervical Cancer Guidelines as a second-line therapy for HER2-mutated tumors, based on Phase II SUMMIT trial results.

Glaukos submitted its US FDA New Drug Application for Epioxa, a non-invasive corneal cross-linking therapy for keratoconus, with data from 2 Phase 3 trials. Epioxa aims to reduce procedure times, improve comfort, and shorten recovery, without requiring epithelium removal.