ViiV Healthcare, a global specialist HIV company majority-owned by GSK, in collaboration with United States-based Pfizer Inc and Japan-based Shionogi Limited as shareholders have revealed positive Week 48 results from the phase III TANGO study of dolutegravir plus lamivudine, it was reported yesterday.
The TANGO study was conducted to evaluate whether adults living with HIV-1 who had maintained viral suppression for around six months on a tenofovir alafenamide fumarate-containing regimen of around three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the tenofovir alafenamide fumarate -containing regimen. The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA up to 50 copies per millilitre using the FDA Snapshot algorithm at Week 48.
No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines. The complete results from the study will be presented at the 10th International AIDS Society Conference on HIV Science to be held from 21 July to 24 July in Mexico City.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval