Date: 2018-04-26
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Association for Cancer Research Annual Meeting
Company: Y-mAbs Therapeutics (USA - NY)
Product: burtomab (131-I-8H9), now omburtamab
Action
mechanism:
- monoclonal antibody/radiopharmaceutical product. 131-I-8H9 monoclonal antibody is a radioimmunoconjugate consisting of the iodine 131-radiolabeled murine IgG1 monoclonal antibody 8H9 directed against the surface immunomodulatory glycoprotein 4Ig-B7-H3 with potential radioimaging and radioimmunotherapeutic uses. Iodine I 131 monoclonal antibody 8H9 binds to 4Ig-B7-H3 (human B7-H3 with 4 Ig-like domains) and may be used to radioimage and/or destroy tumor cells that express tenascin. In vitro, it has been shown that monoclonal antibody-mediated masking of 4Ig-B7-H3 on neuroblastoma cells resulted in the enhancement of natural killer (NK)-mediated lysis of target cells.
- Burtomab has been created by Memorial Sloan Kettering Cancer Center and licensed to Y-mAbs Therapeutics. MSK’s Nai-Kong Cheung, MD, PhD, created and tested this antibody.
Disease: desmoplastic small round cell tumor (DSRCT)
Therapeutic
area: Cancer - Oncology - Rare diseases
Country: USA
Trial
details: (NCT00445965)
Latest
news:
- • On April 16, 2018, Y-mAbs Therapeutics announced Phase I clinical trial data for omburtamab in Desmoplastic Small Round Cell Tumor (DSRCT), which is a rare sarcoma of adolescents and young adults. Dr. Shakell Modak from Memorial Sloan Kettering Cancer Center (MSK) presented data at the American Association for Cancer Research Annual Meeting on April 15, 2018 in Chicago, Illinois.
- The phase I study of radioiodinated omburtamab was conducted at MSK to evaluate toxicity, pharmacokinetics, biodistribution and efficacy. Cohorts of 3-6 patients were treated with escalated doses of intraperitoneal 131I- omburtamab. A prior dose of 2mCi 124I-omburtamab intraperitoneal was used to acquire PET images and biodistribution data. A total of 41 DSRCT patients were treated at doses of 30-90mCi/m2. Maximum tolerated dose was not reached and there were no dose-limiting toxicities. Major adverse events were grade 4 neutropenia (n=3). Median progression-free survival in patients undergoing complete cytoreductive surgery (n=20) followed by RIT and whole-abdominal radiotherapy was 18.5±2.4 months from administration of RIT. Of these, 18 and 11 patients are overall and progression-free survivors, respectively, at a median follow up of 14 months post-RIT. In contrast a patient with gross residual disease pre- RIT (n=1) had median progression free survival of 5.3±3.8 months (p<0.05 for PFS and OS compared to patients undergoing complete surgery). 131I-omburtamab intraperitoneal RIT appears to have activity against micro-metastatic DSRCT.
- A Phase II trial in this indication is anticipated to commence shortly.
Is
general: Yes
