Dr. Horn on Monitoring Response and Resistance to Ensartinib in ALK+ NSCLC

Xcovery Announces the Appointment of Li Mao as Chief Executive Officer and Giovanni Selvaggi as Chief Medical Officer

Xcovery Announces Initiation of Phase 2 Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations

Check out our recent article posted on OncLive highlighting the promising activity observed with our investigational ensartinib agent!  https://lnkd.in/eMTwb-i

 

Xcovery is presenting a poster entitled:

eXalt3: First-Line Ensartinib (X396) versus Crizotinib in Advanced ALK-Rearranged NSCLC (eXalt3): A Randomized, Open-Label, Phase 3 Study

Yi-Long Wu, Tony S. Mok, Martin Reck, Heather A. Wakelee, Chris Liang, Fenlai Tan, Kimberly Harrow, Vance Oertel, Gary Dukart, Lieming Ding, Leora Horn

The overall study objective is to evaluate the efficacy and safety of ensartinib vs crizotinib in patients with ALK+ NCSLC that have received up to 1 prior chemotherapy regimen and no prior ALK TKI. Ensartinib exhibited favorable effectiveness in in vitro and in vivo studies, including mutations that are resistant or become resistant to crizotinib. The eXalt3 trial was initiated in June 2016 and over 42 sites have been activated. Xcovery is presenting updated preliminary data on the efficacy and safety of ensartinib.

Xcovery is presenting a mini-oral presentation entitled:


Response to Ensartinib in TKI naïve ALK+ NSCLC patients

Heather A. Wakelee, Rachel E. Sanborn, Jorge Nieva,  Saiama Naheed Waqar, Christina E. Brzezniak, Jessica Bauman, Joel W. Neal,  Gary Dukart,  Fenlai Tan, Kimberly Harrow, Chris Liang, Leora Horn

Ensartinib has shown clinical activity in patients harboring an ALK alteration including EML4-ALK fusion or point mutation such as T1151M, G1269A, L1196M, G1202R and V1149M. Xcovery is presenting preliminary results from the ongoing eXalt2 phase 2 study. Overall response rates in the ALK TKI naïve sub-population are 92{78c6e071319c08d812d0e84a9525ce4b74a9cc2d8ca16eea73b7762889119219} in NGS confirmed ALK+ subjects.

Durable responses and clinically meaningful intracranial responses were observed. Ensartinib is generally well tolerated with the most common AE, rash, being easily treated. Responses are also seen in patients treated with at least one 2nd generation ALK TKI and in patients with prior crizotinib. The eXalt3, a phase III trial, is ongoing, comparing ensartinib to crizotinib in TKI naïve ALK-positive NSCLC patients.