Clinical Trials
3
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2019
Active, not recruiting
1
33.3%
Completed
1
33.3%
Terminated
1
33.3%
No approval data available
- The GEMSTONE-303 Phase III trial demonstrated that sugemalimab plus chemotherapy significantly improved overall survival to 15.6 months versus 12.6 months with chemotherapy alone in advanced gastric cancer patients with PD-L1 CPS ≥5. - Cost-effectiveness analysis revealed incremental cost-effectiveness ratios of $80,573.50 per QALY for CPS ≥5 patients and $64,428.81 per QALY for CPS ≥10 patients, both exceeding China's willingness-to-pay threshold of $40,344. - A 40% price reduction could make sugemalimab cost-effective in the CPS ≥10 subgroup, with a 48% probability of being economically viable at the current threshold. - Higher PD-L1 expression levels showed improved cost-effectiveness ratios, suggesting biomarker-driven patient selection could optimize treatment value.
- Orbital Therapeutics has appointed Adam Raff, M.D., Ph.D., as Senior Vice President of Clinical Development to oversee clinical and regulatory strategy for the company's RNA medicine portfolio. - Dr. Raff will lead the advancement of OTX-201, a potential best-in-class program targeting B cell-driven autoimmune diseases, with clinical development expected to begin in the first half of 2026. - The appointment comes as Orbital progresses OTX-201 through IND-enabling studies following encouraging preclinical data, positioning the company to translate its innovative RNA platform into clinical applications. - Dr. Raff brings over a decade of drug development experience, including leadership roles at Montai Therapeutics, EQRx, and LEO Pharma, with extensive expertise in immunology and inflammatory disorders.
• The Janus Kinase (JAK) inhibitor pipeline is actively being developed by multiple companies, showing promise in treating various autoimmune and inflammatory diseases. • Key companies such as Incyte, AbbVie, and Bristol Myers Squibb are advancing JAK inhibitor therapies through clinical trials and regulatory submissions. • Emerging therapies like povorcitinib, upadacitinib, and deucravacitinib have demonstrated efficacy in treating conditions like hidradenitis suppurativa, axial spondyloarthritis, and plaque psoriasis. • The JAK inhibitor market is driven by the rising prevalence of chronic diseases and substantial investments in research and development, offering targeted treatment approaches.
• RMC-6236 demonstrates encouraging anti-tumor activity across multiple RAS variants (G12D, G12V, and G12R), with a 38% objective response rate in non-small cell lung cancer. • RMC-6291 shows a 50% objective response rate in lung cancer patients who progressed on prior KRAS G12C inhibitors, suggesting clinically meaningful differentiation. • Revolution Medicines anticipates initiating a pivotal Phase 3 trial for RMC-6236 in second-line RAS-mutant non-small cell lung cancer in 2024. • The company expects to acquire EQRx, gaining $1.1 billion in net capital to support the late-stage development of its RAS(ON) inhibitor pipeline.
