We are excited to share the updated efficacy&safety data of
#Zidesamtinib (NVL-520), a next-generation ROS1-selective, TRK-sparing, brain-penetrant inhibitor in ROS1 fusion solid tumors, from the ongoing
#ARROS1 global phase 1/2 trial, presented today
#ESMO24 by
@BenjaminBesseMD
๐ MTD not reached, RP2D selected (100 mg oral daily)
๐ฅ ORR 44% in pts who were heavily pretreated (1-4 prior ROS1 inhibitors), 51% if repotrectinib-naive
๐ฅ ORR 41% in pts who received 2 or more prior ROS1 TKIs
๐ฅ ORR 38% in pts post-repotrectinib and with ROS1 G2032R mutation (the most common on-target mutation resistant to earlier-generation ROS1 TKIs)
โ
CNS-active with IC-ORR of 50%, including in pts post-lorlatinib / post-repotrectinib
๐ Safety profile very favorable, well tolerated by pts notably with sparing of TRK-mediated neuro-toxicity (โผ๏ธimportant in the ROS1 treatment landscapeโผ๏ธ)
Encouraging results, warranting further investigation including in TKI-naive and TKI-pretreated settings
๐ Congratulations to
@BenjaminBesseMD on the presentation
๐ Grateful to co-investigators and patients, families and caregivers
@alexdrilon B.C. Cho
@DRCamidge @JoelNealMD C.C. Lin
@StephenVLiu @MNagasaka S. Kao
@EnriquetaFelip A.J. van der Wekken J. Bauman
@ShirishGadgeel @ViolaWZhu
@MGHCancerCenter
@MassGeneralNews @GustaveRoussy @MSKCancerCenter @ros1cancer #LCSM