Phase II Clinical Trial NCT05384626 by Nuvalent, Inc. A Study of NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Who is this trial for: NVL-655 is a 4th generation, brain-penetrant, ALK TKI inhibitor created to overcome several limitations observed with currently available therapies. NVL-655 is designed to have activity in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R/L1196M (“GRLM”), G1202R/G1269A (“GRGA”), or G1202R/L1198F (“GRLF”). In other words, it is for patients for whom other ALK TKIs have failed under certain conditions.

Clinical TrialsKirk SmithNovember 5, 2024Clinical Trials, Nuvalent, NVL-655, ALKOVE-1

Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655

CAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).

Clinical TrialsKirk SmithMay 23, 2024Nuvalent, Research

First two weeks on NVL-655 clinical trial: Field Research for the Clinical Trials Committee

I started on the Phase II NVL-655 trial on March 1st, 2024, at UC Davis’s Sacramento campus, a seventy-five-mile ride from my house. I had pre-registered with Dr. Jonathan Riess’s trial coordinator in December, sending records from my oncologist electronically, and answering a lot of questions. They wanted a record of my initial cancer, and details on the mutations that came up with various progressions, along with all the dates. The current mutational profile was most important to the doctor for qualification to participate. My local oncologist knew Dr. Riess personally, which helped, I think, and having your oncologist touch base with a prospective trial-coordinating doctor can help open the door.

Clinical Trials, Patient Stories, ResearchKirk SmithMarch 24, 2024Nuvalent, Clinical Trials

PATIENT SPOTLIGHT: Andrej Krivda, Wettingen, Switzerland

We interviewed fellow ALKie Andrej Krivda on his very interesting journey with ALK+ lung cancer and all the unexpected twists and turns he’s had to navigate since diagnosis. Andrej is the very first person to enter the Nuvalent NVL-655 clinical trial in Spain and one of the first patients to take part in the trial in all of Europe, and we were very interested in his perspective. He also happens to have a fascinating personal history. Enjoy the read!

Patient Stories, Clinical TrialsKirk SmithMarch 19, 2023Patient Spotlight, Clinical Trials, Nuvalent

The New ALK Inhibitor: NVL-655 Expands Clinical Trial Sites

NVL-655 is a new experimental ALK inhibitor that is designed to treat ALK cancers, especially those that have become resistant to ALK inhibitors like Lorlatinib, Alectinib, and Brigatinib. This brain-penetrable drug not only addresses the typical ALK mutation, but it also targets compound mutations that tend to occur when there is tumor progression.

Clinical TrialsKirk SmithNovember 8, 2022Clinical Trials, Nuvalent

ALKOVE Clinical Trial, a 4th Generation TKI from Nuvalent

The Phase 1/2 trial of Nuvalent, Inc.’s NVL-655, the fourth generation ALK TKI, has begun at Sarah Cannon Research Institute in Nashville, soon to be followed by additional locations. For patients currently on Lorlatinib, NVL-655 provides a hope-filled option for those who test positive for certain mutations that are common upon progression on Lorlatinib. The trial is also open to a range of patients described below that are progressing after other treatment options.

Clinical TrialsKirk SmithJuly 18, 2022Clinical Trials, Nuvalent, ALKOVE-1