Nuvalent Doses First Patient in Phase 3 ALKAZAR Trial for Neladalkib in ALK-Positive NSCLC

Nuvalent Inc. (NASDAQ:NUVL) is one of the best mid cap pharma stocks to buy. On July 21, Nuvalent announced that the first patient had been dosed in ALKAZAR, which is its global Phase 3 randomized, controlled trial. The trial is evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer/NSCLC, comparing it against ALECENSA (alectinib), which is a front-line standard of care.

The ALKAZAR trial is designed to enroll ~450 TKI-naïve patients with advanced ALK-positive NSCLC. Patients will be randomized 1:1 to receive either neladalkib monotherapy or alectinib monotherapy. The primary endpoint for the trial is progression-free survival/PFS based on Blinded Independent Central Review/BICR.

Nuvalent Doses First Patient in Phase 3 ALKAZAR Trial for Neladalkib in ALK-Positive NSCLC

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Neladalkib is a novel brain-penetrant ALK-selective inhibitor specifically created to overcome the limitations of currently available ALK inhibitors. It is designed to remain active in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including those with single or compound treatment-emergent ALK mutations like G1202R.

Nuvalent Inc. is a clinical-stage biopharmaceutical company that develops therapies for patients with cancer.

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This article is originally published at Insider Monkey.