Clinical Trial News

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.

The FDA granted accelerated approval to encorafenib, cetuximab, and mFOLFOX6 for mCRC with a BRAF V600E mutation. Data from the BREAKWATER trial showed a 61% ORR with the combination vs 40% with chemotherapy. Common adverse events included peripheral neuropathy and nausea. Encorafenib is recommended at 300 mg daily with cetuximab and mFOLFOX6.

Vivos Inc. initiates first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India, successfully treating five cancer patients. The trial aligns with the protocol for the planned Mayo Clinic study in the U.S., focusing on safety. Vivos continues discussions with the FDA to initiate trials at Mayo Clinic, aiming to expand indications for RadioGel® in the U.S. The study plans to expand to 30 patients, targeting various cancerous nodes, with results expected in H1 2025.

Nuvation Bio Inc. announced the FDA accepted its NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, with a PDUFA goal date of June 23, 2025. The NDA is supported by TRUST-I and TRUST-II Phase 2 studies data, showing durable responses and prolonged PFS. The company's stock has returned 79.87% over the past year, and it maintains strong financial health with a current ratio of 9.57. Taletrectinib has Breakthrough Therapy Designation and Orphan Drug Designation.