pembrolizumab (KEYTRUDA®)
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Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers
Prnewswire· 2026-03-10 12:47
Core Insights - Citius Oncology announced positive topline results from a Phase 1 clinical trial of LYMPHIR in combination with pembrolizumab for patients with relapsed or refractory gynecologic cancers, indicating potential for enhanced efficacy of immune checkpoint inhibitors [1][2] - The study showed a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR) among evaluable patients, suggesting promising anti-tumor activity [1] Company Overview - Citius Oncology is focused on developing and commercializing novel targeted oncology therapies, with LYMPHIR being a key product approved for treating relapsed or refractory cutaneous T-cell lymphoma [1][2] - The company has robust intellectual property protections, including orphan drug designation and pending patents for immuno-oncology applications, which strengthen its competitive position in the market [2] Clinical Study Details - The Phase 1 study was led by the University of Pittsburgh and involved 25 evaluable patients, with no unexpected safety signals reported [1] - LYMPHIR was administered intravenously in escalating doses alongside pembrolizumab, with the aim of establishing a recommended dose for future studies [1] Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [2] - The combination therapy approach with LYMPHIR and pembrolizumab may address the unmet needs in treating recurrent or metastatic gynecologic cancers, which have limited treatment options [1][2]