Nuvalent has developed NVL-520, a new treatment for patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have previously undergone treatment with two or more ROS1 tyrosine kinase inhibitors (TKIs).
NVL-520 is an innovative brain-penetrant ROS1-selective tyrosine kinase inhibitor (TKI). It aims to address key clinical challenges such as treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events associated with existing ROS1 TKIs.
Unlike current options, NVL-520 is engineered to maintain effectiveness against tumours that have developed resistance to other ROS1 inhibitors, including those with specific mutations like G2032R.
Moreover, its design enables better penetration into the central nervous system, offering improved treatment for patients with brain metastases, while avoiding inhibition of the related tropomyosin receptor kinase (TRK) family. These features make it a promising candidate for driving significant and lasting responses in patients across various stages of therapy.
ROS1 rearrangements are found in around 3% of metastatic NSCLCs, with a significant portion of patients presenting with brain metastases at diagnosis and developing resistance mutations after initial treatment. Currently, there is no established standard treatment for patients who have undergone multiple rounds of ROS1 TKIs.
Nuvalent has received breakthrough therapy designation from the U.S. FDA for NVL-520, recognising its potential to address significant unmet medical needs in this patient population.
