ALKAZAR Ph 3 Trial of Neladalkib for Patients with TKI-naïve ALK-positive NSCLC initiated

“Neladalkib is rationally designed with the goal of addressing the combined medical needs of treating key drivers of disease progression such as brain metastases and treatment-emergent resistance mutations, while also offering a generally safe and well-tolerated safety profile supportive of long-term treatment,” said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. “We have been encouraged by neladalkib’s clinical profile to date, which we believe not only supports its potential to address clear medical needs for TKI pre-treated patients with advanced ALK-positive NSCLC, but also to translate to deep, durable responses for patients in the front-line setting. The initiation of the registration-directed ALKAZAR study enables us to explore this potential by comparing neladalkib to a front-line standard of care in a randomized, controlled clinical trial setting, and advances us towards our ultimate goal of bringing neladalkib to all patients with advanced ALK-positive NSCLC.”