Welcome to the September 2025 edition of the Rare Mutations and Fusions newsletter from LUNGevity's Patient Gateways.
Since our last newsletter in March, we have seen a lot of progress in the lung cancer space for treating patients with rare driver mutations, including new drug approvals by the US Food and Drug Administration (FDA).
In June, the FDA approved taletrectinib to treat locally advanced and metastatic NSCLC with ROS1 rearrangements. Taletrectinib is a tyrosine kinase inhibitor (TKI) that targets ROS1 and is used to treat newly diagnosed patients and patients whose tumors have become resistant to prior treatments. Studies have shown that 85%-90% of patients without previous treatments had their cancer shrink or disappear with taletrectinib treatment (overall response rate).
Later, in August, the FDA issued an accelerated approval for zongertinib to treat patients with unresectable or metastatic NSCLC with mutations in the HER2 gene. Zongertinib is a TKI that disrupts the activity of the mutated HER2 protein to slow or stop cancer growth. A clinical trial studying 71 patients with HER2 mutations who were previously treated with chemotherapy showed 75% of patients had their tumors shrink or disappear with zongertinib treatment (overall response rate).
While these treatments have made it all the way to FDA approval stage, there are many treatments being tested in the laboratory and in clinical trials. One promising example that was showcased at the recent World Conference on Lung Cancer is zidesamtinib, a TKI being tested in the phase1/2 ARROS-1 trial. This drug has been developed to target tumors with ROS1 mutations, with a particular emphasis on treating brain metastasis and drug-resistant tumors. The results were exciting, with 84% of the patients in the study seeing a benefit from treatment for at least 6 months and 62% benefiting from treatment for at least 18 months (duration of response).
You can learn more about innovative research that is underway for many different types of lung cancer. Be sure to check out LUNGevity’s ongoing coverage of the world’s biggest research conferences and their impact on lung cancer treatment and patient care.
Research News
Dr Dietrich on the Efficacy and Safety of Taletrectinib in ROS1+ NSCLC
OncLive
July 31, 2025
FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC
Drugs
August 10, 2025
HER2 alterations in non-small cell lung cancer (NSCLC): from biology and testing to advances in treatment modalities
Frontiers Blog
June 20, 2025
Emerging Oral HER2-Targeted TKIs (Zongertinib and Sevabertinib): Efficacy and Safety in HER2-Mutated NSCLC
OncLive
June 13, 2025
Zidesamtinib Demonstrates Responses in ROS1-Positive NSCLC
ASCO Post
September 9, 2025
Get Connected
It’s Finally Here! The International Lung Cancer Survivorship Conference
This free, virtual conference will give you a better understanding of the science behind your disease so you can collaborate more effectively with your healthcare team. Connect in real time with specialists and patient advocates who understand your diagnosis, hear inspiring survivor stories, and learn how to use your voice in research and policy advocacy. This online conference is September 26-27, 2025. Register today.
Join us for the Rare Mutations Virtual Meetup
This is an easy way to build your community. On the first Wednesday of each month, you can connect with others who understand what it’s like to live with rare mutations lung cancer. The next Rare Mutations Meetup is happening on Wednesday, October 1, 2025 at 3 pm ET.
Register for this virtual meetup to get a confirmation email with details about how to join the meeting. New attendees are always welcome and encouraged to join! Can’t make it? Don’t worry, there’s a full list of virtual meetups to fit your schedule.
Have You Seen?
Highlights from the Biggest Research Conferences
LUNGevity brings you coverage from all the big oncology conferences so you can stay up to date on the progress and breakthroughs in lung cancer research and treatment. Stay tuned for our upcoming coverage from the World Conference on Lung Cancer that took place in Barcelona, Spain, from September 6-9, 2025. In the meantime, be sure to check out the summer’s research highlights from the annual meeting of the American Society of Clinical Oncology. Learn more.
Throwing RET+ Lung Cancer into the Trash Can
Researchers are taking an innovative approach to overcoming drug resistance by harnessing the tumor cell’s recycling system to break down cancer-driving RET proteins. This exciting work could lead to longer-lasting treatments with fewer side effects for people living with RET-positive cancers. This groundbreaking research is conducted by Dr. Justin Drake at the University of Minnesota through the 2024 RETpositive/LUNGevity Translational Research Award. Learn more.
Integrative Medicine: What Is It? And Why You Should Know About It
Integrative medicine is a growing field that can be used to improve a patient's quality of life. People living with many types of cancer, including lung cancer with rare mutations and fusions, have benefited from integrative medicine. Learn about integrative medicine from Kim Lowery Walker, MBA, LCSW, Integrative Psycho-Oncology Program Manager and oncology therapist at Inova Peterson Life with Cancer, through a recorded webinar moderated by Misty Shields, MD, PhD, IU Health, and LUNGevity’s Ann Fish-Steagall, RN, BSN, SVP of Patient Services and Health Care Delivery. Learn more.
… and there is always so much more to explore on the Rare Mutations & Fusions Patient Gateway.
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If you need further assistance along your lung cancer journey, please email us at support@lungevity.org. Our team is always here to assist you.
