On September 30, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, reported updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain (Press release, Five Prime Therapeutics, SEP 30, 2019, View Source [SID1234539934]). The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The FPA150 data presented at ESMO (Free ESMO Whitepaper) included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer.
"B7-H4 is a novel T cell immune checkpoint and the early results from the phase 1b monotherapy portion of our FPA150 study provide the first clinical demonstration of B7-H4 as a potential therapeutic target," said Helen Collins, Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Based on the study results to-date, we continue to believe that the most promising opportunity for FPA150 is in combination with other therapeutic agents."
Key highlights from the presentation include:
Phase 1 FPA150 Monotherapy:
Two patients with B7-H4 positive ovarian cancer experienced a confirmed partial response (one in the dose escalation and one at the recommended dose of 20mg/kg)
10 patients with stable disease remain on therapy as of August 9, 2019
Increased tumor infiltration of T cells and NK cells observed in patients with a partial response or stable disease
Recommended dose of 20 mg/kg was well tolerated in all patients
Phase 1 Safety Lead-in Combination of FPA150 + Pembrolizumab :
Combination was well tolerated in the first four patients treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)
Expansion initiated in August 2019 in a cohort of ovarian cancer patients with B7-H4 overexpression
About FPA150
FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 overexpression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as promoting enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4.