Add fuel to the fire: Inflammation and immune response in lung cancer combined with COVID-19
Learning To Live With Advanced Non-Small Cell Lung Cancer
Coretta found a path towards positivity and hope through her journey of being diagnosed with advanced non-small cell lung cancer. Coretta is a LIBTAYO® (cemiplimab-rwlc) patient and is being compensated by Regeneron for her time in sharing her story. Source: Regeneron
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By Regeneron
When Coretta received a diagnosis of stage 4 non-small cell lung cancer (NSCLC), she was shocked. Thanks to her oncologists, they established a care plan together. Having her treatment plan underway allowed Coretta to return some of her attention to the things she enjoys such as spending time with her family, working on her business and visiting the beach when possible.
Before her diagnosis, Coretta enjoyed spending time with her husband and daughters, taking trips to Atlantic City, N.J., and visiting her mother in Florida. Coretta was excited to follow her entrepreneurial spirit and be her own boss by opening a new consignment shop, selling small businesses' wares from candles and lemonade to soaps and jars of honey. During the pandemic, businesses were suffering, and she was thrilled to help her community.
Shortly after opening her business, Coretta started experiencing back pain that would not go away. Thinking she had just pulled a muscle while restocking shelves and organizing her new shop, she went to see a doctor. During this first assessment she explained, "I was diagnosed with a urinary tract infection and sent home with antibiotics." A week later, the pain had not improved and, in fact, had gotten much worse. Coretta's primary care doctor sent her to the emergency room where, after several tests and hours of waiting, she was diagnosed with advanced NSCLC. Eight in 10 people diagnosed with NSCLC receive their diagnosis at a later stage, just like Corettai. Through additional testing, she soon discovered the cancer had metastasized – or spread – to her spine and brain.
"I wondered what was next," said Coretta. "I had heard of lung cancer before — in fact, my mother was diagnosed with lung cancer two years before I was," Coretta said. It was a scary diagnosis – lung cancer affects more than 230,000 people every yeari, but Coretta put her energy into learning more. "I started to do additional research online about advanced non-small cell lung cancer to prepare for conversations with my doctor."
After her diagnosis, it became increasingly difficult for Coretta to maintain her daily routine. Her family outings slowed down, and unfortunately, she had to close her business.
Coretta made a decision while in the hospital: "I wasn't going down without a fight."
When Coretta met with her oncologist for the first time, she felt very fortunate that he appreciated her desire to learn, understand more about the disease and be involved in her treatment plan. After going through a similar cancer diagnosis with her mother, whom she is incredibly close with, Coretta was determined.
"We sat down together and talked through all my options and agreed on a plan for my treatment: straight to radiation to try to shrink the tumors, and then treatment with something he explained was an immunotherapy," Coretta said.
Coretta enjoys a picnic with her daughter, Iyyonnah. Source: Regeneron
After learning that her tumors had a high PD-L1 expression, which is a cancer cell marker that can help oncologists determine if a targeted treatment option might be right for patientsii, her oncologist recommended an immunotherapy that had been approved by the U.S. Food and Drug Administration called LIBTAYO® (cemiplimab-rwlc).
LIBTAYO (cemiplimab-rwlc) is a prescription medicine used to treat adults with NSCLC. LIBTAYO may be used alone as a first treatment option when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1," and your tumor does not have an abnormal "EGFR," "ALK," or "ROS1" gene. It is not known if LIBTAYO is safe and effective in children.
LIBTAYO can cause your immune system to attack normal organs and tissues in areas of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems can happen anytime during treatment or even after treatment has ended.
LIBTAYO can be administered in a hospital, clinic or infusion center as a 30-minute intravenous (IV) infusion every three weeks until the disease progresses or if side effects become intolerable.
Coretta's oncologist explained to her the risks and benefits of LIBTAYO. She was appreciative that her healthcare team took the time to make sure she was well informed prior to making any definitive decisions about her course of treatment. After deciding to move forward with LIBTAYO treatment, she learned more about a patient support program that helps patients navigate their journey by providing support, financial and educational tools, and resources and healthcare referrals for those who may be eligible.
"The oncology clinic even sent me home with information about treatment and patient support options, which answered a lot of my questions," said Coretta. "My advice to anyone else newly diagnosed would be to do your research – get a good understanding of your condition and treatment options before meeting with your doctor. I encourage you to advocate for yourself and keep fighting."
Coretta continues to receive infusions. She plans to continue to work with her doctor and monitor her treatment. "I trust my doctor immensely."
When asked what she's learned since her diagnosis, Coretta said, "I have had to learn to live with this disease and cope with all of it. I've learned to focus on my mental health and have patience which has been great for me."
Coretta's journey has proven the strength of her relationships with her family as well. "My husband and daughters are amazing. They are my rocks," she said. Her experience has also inspired her family and loved ones to be more aware about cancer and to receive regular checkups.
Individual results with LIBTAYO treatment may vary. Coretta has gone back to some of her routines, from re-opening her business to making plans for the activities she enjoys with the people she loves. Her plans include travel, such as resuming her visits with her mother and taking trips to different places when she can. "I'd be happy to go anywhere nice with a beach," Coretta said.
Her determination to understand her diagnosis and be involved in her treatment plan gave her a different perspective for her future. "I know the experience is not going to be the same for everyone as it has been for me," Coretta shared, "and how you feel today is not necessarily how you will feel tomorrow, but you have to start with hope."
iAmerican Cancer Society (2024). Cancer Facts & Figures 2024. American Cancer Society. Https://www.Cancer.Org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.Pdf
iiAmerican Lung Association (2022). PD-L1, Pd1, TMB and Lung Cancer. American Lung Association. Https://www.Lung.Org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/pdl1-pd1-tmb
Story from Regeneron: US.LIB.24.09.0050 1/2025
Natera Announces Medicare Coverage Of Signatera™ For Surveillance In Lung Cancer
AUSTIN, Texas, February 25, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that its Signatera test has met coverage requirements from the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostics Services Program (MolDX) for patients with non-small cell lung cancer (NSCLC). This coverage applies to patients with stage I-III NSCLC with resectable or unresectable disease in the surveillance setting. It expands upon preexisting Medicare coverage of Signatera for monitoring of immunotherapy, a common form of treatment for NSCLC in both the adjuvant and metastatic settings.
Lung cancer is the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths. In 2025, it will have an estimated incidence and mortality of 226,650 and 124,730, respectively, and an average age at diagnosis of 70 years old.1 While significant advances have been made in the treatment of NSCLC in recent years, the 5-year overall survival rate remains poor (28% for all SEER stages combined).2
Several limitations exist with existing surveillance tools, including limited sensitivity,3 difficulty in interpretation of CT scan results,4 and non-specific findings,5 This highlights the need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms, at a time when therapy might provide greater clinical benefit.
Signatera test performance and utility in the surveillance setting for stage I-III NSCLC was validated in three independent peer-reviewed studies,6-8 to support this Medicare coverage determination. Across these studies, longitudinal sensitivity to extracranial recurrence ranged between 93-100%, with specificity ranging from 96-100% and an observed lead time up to one year ahead of imaging (median 5 months).
"CMS's coverage decision expands access to Signatera for patients with the most lethal and one of the most common forms of cancer in the U.S.," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The body of evidence continues to grow demonstrating Signatera's value in risk stratification, treatment response monitoring, and early detection of recurrence to inform treatment decisions across a broad range of cancer indications."
In addition to the coverage in NSCLC, Signatera is also covered by Medicare for adjuvant and recurrence monitoring in colorectal cancer, muscle-invasive bladder cancer, breast cancer, and ovarian cancer; neoadjuvant treatment monitoring in breast cancer; and pan-cancer immunotherapy response monitoring.
Story Continues
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 250 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.Natera.Com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.Natera.Com/investors and www.Sec.Gov.
References
American Cancer Society. Key Statistics for Lung Cancer. Accessed Feb 24, 2025 https://www.Cancer.Org/cancer/types/lung-cancer/about/key-statistics.Html#:~:text=The%20American%20Cancer%20Society%27s%20estimates,men%20and%2060%2C540%20in%20women
American Cancer Society. Lung Cancer Survival Rates. Accessed Feb 24, 2025 https://www.Cancer.Org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.Html
Lou F, Huang J, Sima CS, Dycoco J, Rusch V, Bach PB. Patterns of recurrence and second primary lung cancer in early-stage lung cancer survivors followed with routine computed tomography surveillance. J Thorac Cardiovasc Surg. 2013;145(1):75-81; discussion 81-2.
Zhang X, Liu H, Balter P, et al. Positron emission tomography for assessing local failure after stereotactic body radiotherapy for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012;83(5):1558-65.
Korst et al. Accuracy of Surveillance Computed Tomography in Detecting Recurrent or New Primary Lung Cancer in Patients With Completely Resected Lung Cancer. The Annals of Thoracic Surgery. Volume 82, Issue 3p1009-1015 September 2006
Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
Lebow ES, Shaverdian N, Eichholz JE, et al. CtDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy. Front Oncol. 2023;13:1253629.
Martin TK, Dinerman A, Sudhaman S, et al. Early real-world experience monitoring circulating tumor DNA in resected early-stage non-small cell lung cancer. J Thorac Cardiovasc Surg. 2024:S0022-5223(24)00075-8.
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20250225633734/en/
Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.ComMedia: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.Com
Updated TNM Staging System For SCLC Offers Better Predictive Power
Photo Credit: Mohammed Haneefa Nizamudeen
Researchers recently validated the ninth edition of the TNM staging system for SCLC, finding improved accuracy and predictive power.
The tumor-node-metastasis (TNM) staging system plays a critical role in the prognostic assessment and treatment decisions for lung cancer. Guidelines recommend treatment modalities for patients with small-cell lung cancer (SCLC), which accounts for approximately 10% of the global incidence of lung cancer, based on the TNM classification.
The ninth edition of the TNM staging system (TNM-9) of lung cancer was presented at the 2023 World Conference on Lung Cancer, but there remained a need for proper external validation of the staging system. Previously, researchers validated the TNM-9 using data from the Surveillance, Epidemiology, and End Results (SEER) database from patients with non-small cell lung cancer who underwent lung resection. However, limited by flaws in the SEERS database, researchers could not further differentiate between N2a and N2b classifications.
To address this, and externally validate the TNM-9, researchers examined multicenter data from patients with limited-stage SCLC. The findings were reported in Lung Cancer.
The multicenter study included 408 patients diagnosed with limited-stage SCLC from 2004 to 2021 who underwent lung resection. The majority (86.8%) of patients were men. Most of the cohort (65.7%) were aged 65 or younger; 34.3% were older than 65 years. Surgical approaches included lobectomy (80.4%), sublobectomy (7.8%), and pneumonectomy (11.8%).
Researchers found that the TNM-9 staging system had improved distinguishing ability versus the eighth edition. These findings were observed across all stage groups that were compared (all P<0.05):
Additionally, the TNM-9 demonstrated better predictive power and accuracy for the overall survival (OS) of patients with SCLC compared with the eighth edition:
"Our external validation demonstrates that the ninth edition of pathological TNM staging for limited-stage SCLC is reasonable and valid based on a multicenter study," investigators wrote. "The ninth edition has better prognostic accuracy than the eighth edition."
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