Alternative Nuvalent drug for patients disqualified from NVL-655 for liver toxicity
| Patients that left the Nuvalent neladalkib (NVL-655) trial because of liver toxicity may have another Nuvalent drug available in this specific clinical situation. A small subset of ALK patients was discontinued from the ALKOVE-1 neladalkib trial due to hepatotoxicity, i.e. persistently elevated liver enzymes ALT and AST despite dose reductions. Nuvalent may be willing to treat those discontinued patients with another of their drugs that is currently in trials for ROS1 NSCLC called zidesamtinib, or NVL-520. ROS1 is an oncogene driven lung cancer similar to ALK that affects 1-2% of all lung cancer patients. Zidesamtinib is also a brain-penetrant ALK tyrosine kinase inhibitor (TKI) with promising preclinical anti-tumor activity for ALK-driven NSCLC. I am an ALK patient currently on zidesamtinib since December 15th, 2025 under a single patient investigational new drug (SPIND) filing with the FDA. I had to discontinue neladalkib on the ALKOVE-1 trial because my liver did not tolerate even the lowest dose. This opportunity was initiated via a protocol created by Dr. Jonathan Riess, of University of California, Davis’s Comprehensive Cancer Center in collaboration with Nuvalent. Dr. Riess is a principal investigator (PI) for both the neladalkib trial I left because of hepatotoxicity, and for the zidesamtinib trial. Dr. Riess worked with the Nuvalent team for my SPIND FDA filing, and I am now under his care, as I was during the neladalkib trial. For other patients that left the neladalkib trial due to hepatotoxicity to gain access to zidesamtinib, they must have a doctor that has used the drug and he/she must approach Nuvalent directly. There is no guarantee that additional ALK+ lung cancer patients will be enrolled in a Zidesamtinib SPIND study. Dr. Reiss will be on the next ALKtALK, so join the ZOOM to learn more about the SPIND process. If you had to discontinue neladalkib in the ALKOVE-1 trial due to hepatoxicity, you are welcome to contact me to learn more about this process, please reach out via Facebook Messenger. At this writing I am doing well on zidesamtinib, with only mild side effects typical to TKIs. Jeff Sturm Eleven-year ALK NSCLC survivor |
