JessicaJLinMD

We are pleased to share this article out today in @CD_AACR on the preclinical development and proof-of-concept clinical activity of NVL-655
✅4th-generation, #ALK-selective TKI
✅CNS-penetrant
✅Broad coverage of ALK fusions and mutations, including lorlatinib-refractory compound mutations
🔥Fills an important unmet need for pts with ALK+ lung cancer and other solid tumors

📢Tune in for updated prelim efficacy&safety data from the global ongoing phase I/II study (ALKOVE-1) of NVL-655 to be presented TOMORROW at #ESMO2024!

@ALKPositiveinc @ALKpositiveINT @MGHCancerCenter @MassGeneralNews @alexdrilon @MSKCancerCenter @BenjaminBesseMD @MLJohnsonMD2 @DRCamidge @jii_bum_lee @ViolaWZhu

aacrjournals.org/cancerdiscover…

@MassGenBrigham Thoracic Oncology team couldn't be luckier. Love this group. The future is bright! 🌟🌟 @aebchang @MaryBoulanger4 @SWaliany @ynie_md , Jacqueline Aredo

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

👉 MTD not reached, RP2D selected (100 mg oral daily)
🔥 ORR 44% in pts who were heavily pretreated (1-4 prior ROS1 inhibitors), 51% if repotrectinib-naive
🔥 ORR 41% in pts who received 2 or more prior ROS1 TKIs
🔥 ORR 38% in pts post-repotrectinib and with ROS1 G2032R mutation (the most common on-target mutation resistant to earlier-generation ROS1 TKIs)
✅ CNS-active with IC-ORR of 50%, including in pts post-lorlatinib / post-repotrectinib
🌟 Safety profile very favorable, well tolerated by pts notably with sparing of TRK-mediated neuro-toxicity (‼️important in the ROS1 treatment landscape‼️)

Encouraging results, warranting further investigation including in TKI-naive and TKI-pretreated settings

👏 Congratulations to @BenjaminBesseMD on the presentation
🙏 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

🌟And here with the efficacy and safety data of #NVL655, ALK-selective, TRK-sparing and brain-penetrant 4G ALK TKI, from ALKOVE-1, presented today #ESMO24 by @alexdrilon
✅ ORR 38% in heavily pretreated pts overall (1-5 prior ALK TKIs)
✅ ORR 35% in pts post-lorlatinib (in which setting we currently have no approved ALK TKIs) --> 50-64% in pts with single or compound ALK resistance mutations
✅ ORR 57% in pts lorlatinib-naive

Pleased to share an updated efficacy, safety, and biomarker analysis of Larotrectinib in TRK fusion+ NSCLC, presented at the #WCLC24 today
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