#USA #Cambridge #Nuvalent #Neladalkib #ALK-positive cancers

Nuvalent Unveils Exciting Preliminary Data on Neladalkib

Overview

On October 18, 2025, Nuvalent, Inc. (Nasdaq: NUVL) announced preliminary findings from its ALKOVE-1 Phase 1/2 clinical trial of neladalkib, showcasing its efficacy in treating advanced ALK-positive solid tumors beyond non-small cell lung cancer (NSCLC) during the ESMO Congress 2025 held in Berlin, Germany. This investigational ALK-selective inhibitor is designed to meet critical medical needs within the oncology landscape.

Study Details

Neladalkib is a next-generation ALK inhibitor targeting kinases related to cancer proliferation. As of the data cutoff on August 7, 2025, observations included 34 response-evaluable patients from various solid tumor types outside of NSCLC. Impressively, the overall objective response rate stood at 44%, with significant responses noted among both TKI-naïve (38%) and TKI pre-treated patients (62%). Moreover, 80% of responders maintained treatment without disease progression, demonstrating neladalkib’s potential in offering durable treatment solutions.

Key Findings

Notable individual case studies reinforced the preliminary data, including:

• - A TKI-naïve patient with an inflammatory myofibroblastic tumor achieved partial response ongoing for approximately 12 months, post-standard chemotherapy treatment.
• - A TKI and chemotherapy pre-treated patient with peritoneal mesothelioma also showed partial response for around 16 months.
• - A TKI pre-treated patient with an adenocarcinoma of unknown origin, who previously had brain metastases with an ALK V1180L resistance mutation, displayed a confirmed complete intracranial response after around 10 months of treatment.

Tolerability and Ongoing Trials

Neladalkib exhibited a favorable safety profile, with minimal dose reductions (8.8%) and no treatment discontinuations due to adverse events. This aligns well with its selective design to limit off-target reactions associated with existing therapies.

Currently, the global Phase 2 cohort enrollment continues, focusing on adult and adolescent patients with advanced ALK-positive solid tumors beyond NSCLC. The firm aims to present topline data for TKI pre-treated patients with ALK-positive NSCLC by year-end 2025.

About Neladalkib

Developed to surpass the limitations seen in first and second-generation ALK inhibitors, neladalkib not only aims to treat existing resistance but also provides an improved option for patients facing brain metastases. Its breakthrough therapy designation reflects its potential in addressing unmet medical needs.

Conclusion

The promising preliminary data announced by Nuvalent offers exhilarating insights into neladalkib’s efficacy for patients struggling with advanced ALK-positive solid tumors. Continued development and research in the field of targeted oncology therapies remain crucial as Nuvalent progresses towards delivering potentially groundbreaking treatment methodologies in the fight against cancer.