From Rare Mutation to FDA Approval for NTRK-Positive Lung Cancer
By Dhru Deb, PhD Senior Director, Research and Administration, LCRF
NTRK gene fusions are rare oncogenic drivers, occurring in only a small fraction of lung tumors, and their rarity meant they were often overlooked in drug development. Unlike more common drivers such as EGFR or ALK, there were no targeted therapies specifically designed for patients with NTRK-driven lung cancers, leaving clinicians with limited options beyond conventional chemotherapy and making research both scientifically challenging and financially risky.
In this situation, the Lung Cancer Research Foundation (LCRF) made a prescient bet. By mediating intentions of visionary donors, in 2012 and again in 2015, LCRF awarded Young Investigator grants to Dr. Alexander Drilon, supporting his early work on rare oncogenic drivers like NTRK fusions—at a time when few believed such uncommon alterations could yield viable therapies.
When I reached out, reflecting on this partnership, Alex shared, “We really appreciate the work you are doing with LCRF as well and look forward to continuing to partner.”
That support helped generate the foundational evidence showing NTRK fusions were rare but highly actionable drivers of cancer.
Building on this early work, Dr. Drilon began leading the NAVIGATE clinical trial (NCT02576431) in 2015, testing larotrectinib, a selective TRK inhibitor, in patients with NTRK-driven tumors regardless of cancer type. For NTRK-positive lung cancer patients, the results were encouraging, with many experiencing rapid and durable responses.
As progress continued, attention turned to resistance. In 2021, Dr. Drilon and Dr. Emiliano Cocco identified a new resistance mechanism publishing their findings in prestigious Nature Medicine. As Dr. Cocco noted, “Lung cancer doesn’t stand still and neither can we.”
LCRF sustained its commitment in 2022 by funding Dr. Cocco’s ongoing work to refine treatment strategies.
The impact of this long-term investment became clear in 2025, when NAVIGATE demonstrated clear clinical benefit and the FDA fully approved larotrectinib for NTRK-positive tumors, following its accelerated approval in 2018—the first targeted therapy for this rare driver. What began as a high-risk idea ultimately reshaped care for an underserved group of lung cancer patients, showing how early funding can ensure that even patients with rare cancers are not left behind.
Foundation funds five new research projects, bringing 2025 total to $5.2 million
NEW YORK, January 6, 2026 — The Lung Cancer Research Foundation® (LCRF) recently awarded five new research grants in the following areas: three LCRF Leading-Edge Research Awards, one LCRF Research Grant on Overcoming Resistance in Lung Cancer Award, and one LCRF Minority Career Development Award (CDA) for Lung Cancer. These awards are in addition to the 14 research awards announced in early December 2025.
Also in 2025, LCRF awarded the American Lung Cancer Screening Initiative (ALCSI) a grant to conduct its “Plus One” screening initiative and research study, funded a three-year project in collaboration with the Israeli Cancer Research Fund, and announced two research grants focused on innovative strategies to advance the understanding and management of lung cancers harboring HER2 mutations and/or other HER2 alterations in collaboration with Bayer Pharmaceuticals. Additionally, AstraZeneca partnered with LCRF to fund three awards focused on prevention and early detection.
“AstraZeneca shares LCRF’s commitment to improving survival of people with a lung cancer diagnosis,” remarked Nabil Chebab, US Medical Head, Lung Cancer, AstraZeneca. “We are delighted to collaborate on projects focused on prevention and early detection.”
LCRF funds projects that demonstrate profound promise to make a sustained and lasting impact on lung cancer research and outcomes. The strength of LCRF’s research program is underscored by the trust, generosity, and vision of its partners, fundraisers, and donors.
“LCRF is grateful to everyone who has made this grant cycle the largest in its history – 21 grant awards for more than $5 million,” said Aubrey Rhodes, LCRF’s Executive Director. “Ensuring that lung cancer research maintains momentum in an uncertain funding environment is of utmost importance. LCRF is committed to filling the funding gap. Working toward improving survival for people with lung cancer is our priority.”
“It is gratifying to be able to fund even more innovative projects,” said Kathryn O’Donnell, PhD, chair of LCRF’s Scientific Advisory Board and Associate Professor, Molecular Biology, UT Southwestern Medical Center. “With this year’s grants, LCRF’s total active research portfolio supports more than $21 million in lung cancer research projects. More funding for research means greater opportunities to uncover advances that will have a positive impact for patients.”
LCRF’s Leading-Edge Research Grant in Lung Cancer funds innovative research focused on the diagnosis, treatment, and cure of lung cancer. The LCRF Research Grant on Overcoming Resistance in Lung Cancer is awarded to projects focused on combating therapeutic resistance.
LCRF’s Minority Career Development Award for Lung Cancer is a two-year funding initiative aimed at advancing early-stage researchers from underfunded groups and enhancing their contribution to the lung cancer research workforce.
Additional LCRF 2025 Research Grant Awardees
Leading Edge Grant Program
Riyue Bao, PhD University of Pittsburgh Radiomics to decipher patient and organ heterogeneity in response to immunotherapies in non-small cell lung cancer
Radiomics is emerging as a non-invasive biomarker to predict the efficacy of anti-PD1/PDL1 therapy across cancers and patients with increased organ-level metastasis heterogeneity are more likely to progress. This study aims to develop machine-learning and artificial-intelligence models to distinguish disease control from progression with organ specificity in patients with non-small cell lung cancer. By linking these findings to tumor biology, the resulting data will not only shed light on the mechanisms underlying variations in response to immunotherapies but will also provide essential advancement in the non-invasive biomarker development investigating therapy resistance.
Joseph Chan, MD, PhD Memorial Sloan Kettering Cancer CenterUniversity of Virginia School of Medicine, Charlottesville Biomarkers of response and toxicity to tarlatamab in patients with metastatic small cell lung cancer
Small cell lung cancer (SCLC) is an aggressive and deadly form of lung cancer with limited treatment options and poor long-term survival. However, a newly approved drug represents a promising advance. Although it has shown encouraging early results, one side effect is cytokine release syndrome (CRS)—a potentially serious immune reaction that can cause fever, low blood pressure, and difficulty breathing. The goal of this study is to utilize new technologies in tandem with advanced computer modeling to improve how to predict which patients will benefit from this treatment and who is at higher risk for CRS. The study has two main aims: (1) Predicting who responds to the drug, and (2) Identifying who is at risk for CRS in order to develop a new framework for personalizing treatment, making it more effective and safer, allowing patients to receive treatment more conveniently, avoid dangerous side effects, and ultimately, live longer.
Tom Cunningham, PhD University of Cincinnati Understanding the dependency of RAS-driven lung adenocarcinomas on PRPS enzyme remodeling
Alterations in cellular metabolism are a well-established hallmark of lung cancers driven by the oncogene KRAS. Although much is known about how this occurs, we still lack clinically effective therapies targeting these processes. This study aims to leverage a novel metabolic vulnerability as a safe starting point in order to systematically dismantle the metabolic resiliency of KRAS-driven lung adenocarcinomas, will nominate a path for the development of effective, but less toxic, targeted therapies, and address key questions in basic lung cancer biology at a broad biochemical level. It will deliver new knowledge regarding the mechanisms oncogenic KRAS employs to deregulate gene expression and metabolism, and it will supply new diagnostic assays and therapeutic tools that can translate to the clinic to help patients with lung cancer.
Research Grant on Overcoming Resistance in Lung Cancer
Chendi Li, PhD Massachusetts General Hospital Enhancing anti-tumor chemokines in KRAS G12C inhibitor-resistant non-small cell lung cancer
Over the past few years, treatment options for patients with the KRAS-mutant non small cell lung cancer (NSCLC) have expanded to include immunotherapies and targeted KRAS inhibitors. These agents, while effective in some patients, do not induce deep or durable responses in the majority of patients. This has prompted clinical trials combining KRAS inhibitors with immunotherapies. Early results look promising, with response rates greater than either agent alone. However, 25–40% of patients still do not respond to the combination. Thus, there remains an urgent need to understand why these treatments fail in order to develop new strategies with enhanced efficacy to benefit a greater number of patients. This project seeks to understand mechanisms underlying the failure of some tumors to respond to combined KRAS and PD-L1/PD-1 inhibition. By identifying the transcriptional regulators of chemokines that recruit T cells and turn immune “cold” tumors “hot”, this work will provide a foundation for future efforts to design therapeutic strategies to promote immune cell infiltration.
Minority Career Development Award (CDA)
Juliana Cazarin de Menezes, PhD University of Rochester The role of BMAL1 and circadian disruption in modulating tumor immunity and immunotherapy response in lung adenocarcinoma
Our body runs on a natural 24-hour cycle known as the circadian rhythm, which regulates many important functions, such as sleep, metabolism, and the immune system. Interestingly, recent research has shown that these internal clocks also affect how well cancer treatments work, especially a type of immunotherapy called immune checkpoint inhibitors (ICIs), which help the immune system attack tumors. In people with lung cancer, ICI treatments given in the morning are up to four times more effective than those given later in the day. The main question is why timed immunotherapy might not work in some patients, and what factors might cause it to not work. In lung cancer, the circadian rhythm in the cancer cells is often altered or completely absent. Ultimately, this research could help improve outcomes for lung cancer patients by optimizing the timing of immunotherapy and identifying new markers to guide treatment. If successful, our findings may lead to more personalized and effective approaches to cancer care, taking into account not only the genetic makeup of the tumor but also the biological clock that governs the immune system.
For more information about LCRF and the Scientific Grant Program, visit LCRF.org/Research.
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About the Lung Cancer Research Foundation The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF’s mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 450 research grants, totaling nearly $53 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information about the LCRF grant program and funding opportunities, visit LCRF.org/research.
Contact: Sheila Sullivan Sr. Director, Marketing and Communications ssullivan@LCRF.org
Early Research Funding and Recent FDA Approval of Immunotherapy for Small Cell Lung Cancer
By Dhru Deb, PhD Senior Director, Research and Administration, LCRF
Every so often in cancer research, you experience a moment where everything clicks: years of individual projects, grants, and hypotheses suddenly line up and reveal a bigger story. I felt that recently while tracing the path from the Lung Cancer Research Foundation‘s early investments in small cell lung cancer (SCLC) to the FDA approval of durvalumab in 2024.
And the more I dug in, the clearer it became. This breakthrough didn’t appear out of thin air. It grew directly out of the seeds planted more than a decade ago.
Then came a series of grants from 2014 to 2017 focused on the PD-1/PD-L1 immune axis. At the time, this space was still emerging, especially for SCLC. But those LCRF-funded projects and investigators helped create the basic scientific understanding needed for immunotherapy to be considered for this disease.
Fast-forward to 2018, when the ADRIATIC trial launched and those early threads came together: both Anna Farago and Christine Hann were investigators on this trial. And the therapy being tested was durvalumab, an anti-PD-L1 drug.
In 2021, LCRF funded new research projects focused on figuring out how to improve durvalumab’s effectiveness in SCLC.
Then came the turning point. In 2024, the New England Journal of Medicine published results showing that durvalumab significantly improved both overall survival and progression-free survival for people with limited-stage SCLC. Months later, the FDA approved durvalumab for these patients—a truly meaningful progress in this space in decades. Looking back at the timeline, so many of the people, technologies, and ideas behind this advance could be traced to early LCRF support.
But the story doesn’t end there.
As of December 2025, Christine Hann, who is still at the forefront of SCLC research, is now involved with a new clinical trial (NCT06287775) led by Dr. Charlie Rudin, at Memorial Sloan Kettering Cancer Center. This trial is testing durvalumab combined with ladademstat, an epigenetic therapy, and it’s actively recruiting patients. It seeks to build on the success of PD-L1 inhibition by pairing immunotherapy with epigenetic modulation.
When I spoke to Charlie about the progress so far, he summed it up perfectly:
“Very exciting progress. Much more to do still!”
And he’s right. The durvalumab approval was a milestone, but it’s also a launching point.
This is just another example of the journey of scientific breakthrough. Breakthroughs like this don’t happen because of one big discovery. They happen because, over many years, visionary donors and research partners help LCRF bet early on smart researchers with bold ideas. That impact is felt deeply by people living with lung cancer—as Maida Harris Mangiameli, small cell lung cancer survivor and research advocate, echoed my sentiment:
“LCRF is very important to those of us with lung cancer.”
When we connect the dots, we see a clear, steady line from those early grants to the treatment options patients are relying on today — and hopeful for tomorrow.
From Early Research to New Treatments for Patients with ROS1-positive Lung Cancer
By Dhru Deb, PhD Senior Director, Research and Administration, LCRF
One of my favorite parts of my work at the Lung Cancer Research Foundation (LCRF) is connecting the dots — between groundbreaking research and the real impact it has on people living with lung cancer.
Earlier this summer, the FDA approved Taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
One of the toughest challenges with earlier therapies has been disease progression, especially when the cancer spreads to the brain. Taletrectinib has shown strong response rates and durable efficacy, including the ability to cross into the central nervous system and help patients with brain metastases.
What’s remarkable is how far back the story goes. Thirteen years ago, LCRF recognized the urgent need to explore targeted treatments for ROS1-positive lung cancer. Donors who believe in scientific progress helped to fund the study“Targeted Therapy Approaches to Lung Cancers Harboring ROS1 Gene Rearrangements,” led by Dr. Alice Shaw at Massachusetts General Hospital. Her work laid the foundation for the first-in-human study of Taletrectinib in the U.S. in 2020.
When I reached out to congratulate Dr. Shaw, she said:
“It’s incredibly exciting that ROS1 patients have so many treatment options.”
Moments like this remind me why our mission matters so deeply. The approval of Taletrectinib reflects the long-term impact of LCRF’s early investments in innovative research and the power of visionary donors.
And this is just one of many promising advancements still to come.
Three grants awarded for projects focused on HER2-driven lung cancer
NEW YORK, NY (December 9, 2025) – The Lung Cancer Research Foundation (LCRF), in collaboration with Boehringer Ingelheim, has granted two-year $250,000 awards to three early career investigators for projects that address novel approaches for the treatment of HER2-mutated lung cancer.
The2025 LCRF | Boehringer Ingelheim Early Investigator Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer is awarded to projects that focus on the science behind HER2 mutations as oncogenic drivers of malignancy and/or the development of novel therapeutic approaches for patients with tumors harboring HER2 mutations.
“There is a critical need to define how HER2 alterations drive cancer progression and contribute to both response and resistance,” said LCRF’s Chief Scientific Officer, Antoinette Wozniak, MD. “We are hopeful that these projects will yield discoveries that directly improve care for patients with HER2-altered tumors.”
“We’re proud to support early career scientists follow the spark of an idea that can lead to tomorrow’s breakthrough. Embracing the power of partnership with LCRF and celebrating a diversity of minds brings us closer to meaningful advances in medicines for patients — congratulations to all recipients of this award!” said Bjoern Rueter, U.S. Vice President, Clinical Development and Medical Affairs.
This is one of two funding mechanisms supported by Boehringer Ingelheim in collaboration with LCRF designed to address HER2 mutations in lung cancer. As with all grants selected, these projects underwent rigorous review by LCRF’s Scientific Advisory Board.
The recipients of the 2025 LCRF | Boehringer Ingelheim Early Investigator Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer are:
Pinar Özden Eser, PhD Broad Institute of MIT and Harvard Identifying actionable targets to improve response to therapy among patients with HER2-driven NSCLC
Elizabeth Brunk, PhD The University of North Carolina at Chapel Hill Linking Structural DNA Variation to Therapeutic Response and Resistance in HER2-Mutated NSCLC
Paul Stockhammer, MD, PhD Yale University Molecular determinants of tumor growth and therapeutic response in ERBB2-mutant lung cancer
In 2025, LCRF funded 19 projects totaling $4.45 million, more than any other funding year in its history, thanks to the generosity, commitment and vision of its donors, fundraisers and partners.
“Funding investigators early in their careers is often the catalyst to keeping scientists focused on advancing their best science,” says Kathryn O’Donnell, PhD, LCRF Scientific Advisory Board chair. “With the current uncertainties of federal funding, including the elimination of the Congressionally Directed Medical Research Program’s lung cancer program, funding from organizations like LCRF becomes even more important in maintaining momentum in lung cancer research.”
To learn more about LCRF funded research and its grants program, visit LCRF.org/research.
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About the Lung Cancer Research Foundation (LCRF) The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF’s mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 445 research grants, totaling nearly $53 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information, visit LCRF.org.
About Boehringer Ingelheim in Oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim’s generational commitment to driving scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer’s ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at Cancer | Boehringer Ingelheim US
Balazs Halmos, MD, MS; Lyudmila Bazhenova, MD; and our moderator, Isabel Preeshagul, DO, MBS talked about the exciting research breakthroughs of 2025 and what they’re looking forward to seeing in 2026.
The Lung Cancer Research Foundation® (LCRF) awarded its annual 2025 Scientific Grant Program awards, funding another $1.65 million in new research. This year’s grant cycle includes 11 awards in the following areas: LCRF Leading-Edge Grant in Lung Cancer, LCRF Research Grant on Prevention and Early Detection in Lung Cancer, LCRF Research Grants on Overcoming Resistance in Lung Cancer, and LCRF Minority Career Development Award (CDA) for Lung Cancer.
Earlier this year, LCRF awarded the American Lung Cancer Screening Initiative (ALCSI) a grant to conduct its “Plus One” screening initiative and research study, funded a three-year project in collaboration with the Israeli Cancer Research Fund, and announced two research grants focused on innovative strategies to advance the understanding and management of lung cancers harboring HER2 mutations and/or other HER2 alterations in collaboration with Bayer Pharmaceuticals.
LCRF awards grants for projects that demonstrate profound promise to make a sustained and lasting impact on lung cancer research and outcomes. Support from LCRF’s generous donors and fundraisers made these grant awards possible.
“Our Scientific Advisory Board and Research Advocates reviewed hundreds of submissions, and we’re excited to support the work of these grantees,” said Colleen Conner Ziegler, Chair of LCRF’s Board of Directors. “Keeping patients’ voices at the forefront of the research process is of utmost importance to LCRF and is evident in the projects that were selected for funding.”
“Each year, we are presented with many ideas that have the potential to change how we approach lung cancer prevention, detection and treatment,” said Kathryn O’Donnell, PhD, chair of LCRF’s Scientific Advisory Board and Associate Professor, Molecular Biology, UT Southwestern Medical Center. “At LCRF, we’re committed to funding the most innovative research projects that will have a positive impact on the lives of people living with lung cancer.”
Through its Leading-Edge Research Grant in Lung Cancer, LCRF funds innovative research focused on the prevention, diagnosis, treatment, and cure of lung cancer. This year, LCRF will be funding four projects through this mechanism.
LCRF’s Research Grant on Prevention and Early Detection in Lung Cancer is presented to four investigators whose project facilitates or advances the understanding and characterization of pre-neoplasia or approaches for early detection in non-small cell and small cell lung cancer.
The LCRF Research Grants on Overcoming Resistance in Lung Cancer are presented to two recipients whose projects focus on combating therapeutic resistance.
LCRF’s Minority Career Development Award for Lung Cancer, supported in part by a grant from the LRE Foundation, is a two-year funding initiative aimed at advancing early-stage researchers from underrepresented groups and enhancing their representation in the lung cancer research workforce.
LCRF recognizes exemplary projects through its Joan H. Schiller, MD Award for Scientific Merit in honor of the contributions to LCRF made by Dr. Schiller in her roles as co-founder, scientific advisory board member and board member, as well as her innumerable contributions to the lung cancer community as a clinician, researcher and advocate. This award is presented to the investigator whose proposal was selected for outstanding overall merit by the Foundation’s Scientific Advisory Board. This year’s recipient is Lu Wang, PhD of Northwestern University Feinberg School of Medicine, whose project is titled Therapeutic targeting of ASXL3 protein stability in small cell lung cancer.
“This LCRF Leading-Edge Research Grant will enable my laboratory to investigate how cancer-specific transcriptional programming is driven by dysregulated transcription factors and epigenetic regulators,” remarked Dr. Wang. “Our goal is to leverage these findings to develop new personalized therapeutic strategies targeting transcriptional dysregulation in lung cancer.”
LCRF 2025 Research Grant Awardees
Leading Edge Grant Program
Lu Wang, PhD Northwestern University Feinberg College of Medicine Therapeutic targeting of ASXL3 protein stability in small cell lung cancer Joan H. Schiller, MD Award for Scientific Merit
Timothy Martin, PhD University of Virginia School of Medicine, Charlottesville Defining how UFMylation pathway inhibition enhances anti-lung tumor immunity
Patricia Pereira, PhD Washington University School of Medicine, St. Louis Antibody click for lung cancer therapy
John Prensner, MD, PhD University of Michigan Microproteins as novel disease targets in squamous cell lung cancer
Research Grant on Prevention and Early Detection in Lung Cancer
David Adler, MD, MPH University of Rochester Increasing Lung Cancer Screening Uptake Among Emergency Department Patients
Crispin Hiley, MD, PhD University College, London Determinants of immune age and immune surveillance for early detection
Nicholas Juul, MD Stanford University School of Medicine Identifying biomarkers of precancerous copy number alteration in normal alveolar epithelium
Hilary Robbins, PhD International Agency for Research on Cancer (IARC) Lung cancer risk assessment for people who never smoked
Research Grant on Overcoming Resistance in Lung Cancer
Ximeng Liu, PhD University of Texas MD Anderson Cancer Center Deciphering response and resistance mechanisms to firmonertinib in NSCLC patients with EGFR PACC mutations
Dongsung Kim, PhD Ohio State University A novel targeted therapeutic strategy for KRAS inhibitor resistant lung cancers
Minority Career Development Award (CDA)
Nelson LaMarche, PhD Yale University Defining clinically targetable drivers of pathogenic myeloid cell development for NSCLC immunotherapy
For more information about LCRF and the Scientific Grant Program, visit LCRF.org/Research.
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About the Lung Cancer Research Foundation The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF’s mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 442 research grants, totaling nearly $51 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information about the LCRF grant program and funding opportunities, visit LCRF.org/research.
Contact: Sheila Sullivan Sr. Director, Marketing and Communications ssullivan@lcrf.org
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy. This is the most recent oral tyrosine kinase inhibitor (TKI) that has been approved.
Why it’s important
Alterations in the HER2 gene have been associated with the development and spread of cancer. HER2 mutations occur in about 2-4% of patients with NSCLC. In the past two decades, several clinical trials have investigated the use of anti-HER2 therapies in lung cancer but have led to disappointing results. Progress was made when in 2022, the FDA granted accelerated approval to trastuzumab deruxtecan for patients with unresectable or metastatic NSCLC whose tumors have HER2 mutations and who have received prior therapy. This drug is an antibody drug conjugate, which is a form of “targeted chemotherapy.” Thanks to continued research, zongertinib (another TKI) was approved earlier this year for previously treated HER2-mutated NSCLC — and now, sevabertinib is the third therapy approved for this rare subtype of NSCLC.
Sevabertinib is an oral TKI that specifically targets HER2 mutations. In the SOHO-01 (NCT05099172) clinical trial, 70 patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) mutations who had received prior systemic therapy were treated with sevabertinib. An impressive 71% of the patients had significant shrinkage of their cancer and control of the cancer lasted over 9 months for many of the patients.
The most common side effect was diarrhea which was managed without the need to discontinue the drug. Other common toxicities included rash and nail changes. The prescribing information also contains warnings for potential liver toxicity, pneumonitis (lung inflammation), eye toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.
What it means for patients
Sevabertinib represents another advancement in the treatment of NSCLC patients with HER2 mutations. Since this is an accelerated FDA approval, there will be more trials that will be performed to confirm the effectiveness of the drug. It is important that patients with advanced non-squamous NSCLC have their tumors tested for HER2 mutations.
What to look for
It is likely that sevabertinib will be evaluated as initial treatment for patients with HER2-mutated NSCLC in upcoming clinical trials with the hope that it will be more effective than chemotherapy as a first treatment. We could also see the evaluation of sevabertinib in combination with other agents such as chemotherapy. It is also important to remember that the drug is unlikely to be a cure for these patients and that there is still an urgent need to continue research efforts to determine why cancer cells are or become resistant to treatment. Expect that the development of novel drugs for this type of lung cancer will continue in the future.
To learn more about HER2-mutant NSCLC, download this educational resource. If you have questions, you can connect with our Lung Cancer Support Line at (844) 835-4325 or email support@LCRF.org.
Benay Taub Lung Cancer Research Act to create specialized federal task force
On Nov. 24, U.S. Congressman Josh Gottheimer (NJ-5) announced the introduction of new legislation to combat lung cancer, cut through red tape, streamline health care access, and increase funding for research.
The Benay Taub Lung Cancer Research Act would create a specialized federal task force made up of members from the National Cancer Institute (NCI), National Institute of Health (NIH), and CDC’s National Comprehensive Cancer Control Program to address gaps in access to lung cancer screenings, recommend best practices for early detection, and ensure sufficient funding. The bill is named after lung cancer research advocate and Lung Cancer Research Foundation board member, Benay Taub.
The IMPACT (Improving Medicaid Precision and Cancer Testing) Act would extend Medicaid coverage for medically necessary biomarker testing for lung cancer. The bipartisan bill is co-led by Rep. John Rutherford (FL-5).
The Lung Cancer MAP (Medicare Access to Precise Testing) Act cuts red tape to ensure patients receive the fastest specialized treatment, breaking down barriers that restrict testing only to later-staged cancer. The bipartisan bill is co-led by Rep. Jen Kiggans (VA-2).
Rep. Gottheimer is also supporting the Women and Lung Cancer Research and Preventive Services Act and the Increasing Access to Lung Cancer Screening Act.
“I still cannot believe that I have lung cancer, let alone stage 4 incurable metastatic lung cancer,” Taub told those gathered for the announcement. “I live a healthy lifestyle. I do not smoke. I had no known risk factors, other than one… I have lungs. And if you have lungs, you can get lung cancer.”
Hear her remarks below, along with some words from Rep. Gottheimer.
LCRF is very grateful for the supporters across the country who host creative events that bring people together and make a meaningful impact for lung cancer research. Two incredible examples are Toss for a Cause and the Drive for a Cure Golf Tournament — both born from love, loss, and the determination to make a difference.
Toss for a Cause
What started as a way to honor a father’s memory has grown into an annual tradition that unites an entire community. Founded by Ryan and Jordan Kurrle in memory of Jordan’s father, Alan Eng, who passed away from lung cancer in 2022, the BreathENG for Baba team has hosted a cornhole tournament for the past three years — raising more than $38,000 for lung cancer research.
Held at a local Elks Lodge in the Baltimore-Washington area, the event draws family and friends for an afternoon of cornhole, raffles, food trucks, and laughter. Even those who don’t toss a single bag still show up to support a cause that matters deeply to them. Jordan and Ryan are empowered to raise awareness about lung cancer and the need for research funding!
Drive for a Cure
In Rhode Island, the Drive for a Cure: Gregory Rubino Memorial Golf Tournament has been an annual labor of love for five years, raising approximately $68,000 to fund lifesaving research in Gregory’s memory. Gregory’s brother, Joseph Rubino, leads this special event alongside family and friends. With local sponsors, live music, dinner, and exciting raffles, the tournament has become a cherished tradition that brings hope to all who attend.
Gregory’s story began in late 2020, when he experienced headaches and confusion that led to a devastating diagnosis — stage 4 lung cancer that had spread to his brain. Just five months later, Greg passed away, leaving behind a legacy of strength and love.
This year marked the tournament’s final event, and it was truly one for the books. On behalf of LCRF and everyone impacted by lung cancer, we extend our heartfelt gratitude to the Rubino family for continuing Gregory’s legacy through this remarkable fundraiser.
Whether it’s cornhole or golf or another sport, events like these remind us that coming together can spark real change! (and create some friendly competition!)
