dm+d

Unassigned

New Medicines

Advanced nasopharyngeal cancer - first-line in combination with gemcitabine + carboplatin

Information

New molecular entity
Tessa Therapeutics
Tessa Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Dec 20No longer listed in Tessa pipeline, but no press releases or documents explaining why; plans for development uncertain [6].
Nov 18Has orphan drug status in US [3].
Sep 15FDA grants fast track status to TT10 for treatment of EBV-positive head and neck cancers, including nasopharyngeal carcinoma [3].

Category

Ex vivo activated and expanded, autologous Epstein-Barr virus (EBV) antigen-specific cytotoxic T-lymphocytes
Pharyngeal cancer is relatively uncommon in England and Wales but higher among those with a South Asian background. Nasopharyngeal carcinoma is endemic in Asia and is aetiologically associated with Epstein-Barr virus (EBV). During the past decades, the overall five-year survival rate has improved from 60% to 80% [1].
Advanced nasopharyngeal cancer - first-line in combination with gemcitabine + carboplatin
Intravenous infusion

Trial or other data

Feb 20PIII VANCE study (NCT02578641) is now due to complete collection of primary outcome data in Feb 21 [5].
Dec 19PIII trial (NCT02578641) is no longer recruiting; collection of primary outcome data is due to complete Dec 20 [4].
Jan 18PIII trial (NCT02578641) is still recruiting [2].
Jul 14PIII trial to assess safety and efficacy of gemcitabine and carboplatin followed by TT 10 vs. gemcitabine and carboplatin as first-line therapy, in patients with advanced nasopharyngeal carcinoma starts (FF01; NCT02578641). 330 patientswill be recruited in the US, Taiwan, Thailand, Malaysia and Singapore. The treatment protocol consists of four cycles of gemcitabine and carboplatin, followed by up to six infusions of TT 10. Primary outcome is overall survival; collection of these data is due to complete Dec 19 [2].