The Fight of Our Lives: Confronting the Unmet Need in Lung Cancer

Medical advancements, over the past year, have been game changing for lung cancer patients. In 1971, President Richard Nixon declared war on cancer, and now, we finally have a war on lung cancer.

In 2015, the FDA approved 7 new treatments for lung cancer patients, and 5 of these approvals came over a 2-month period. FDA programs, such as the Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track designations, have allowed the expedited approval of life-saving lung cancer medicines that address unmet medical needs and provide clinical benefit to patients.

As we march into the era of personalized precision medicine and improved clinical trial design, genomic profiling allows us to target and treat specific cancer mutations, by identifying and prescribing the right drug to the right patient, at the right time. Another fantastic addition to our armamentarium is, immuno-oncology (I-O), a therapy that completely upends traditional treatment options using medicines to boost a patient’s own immune system to fight their disease.

Many of us now have a second chance because of the doctors, scientists, and medical researchers working on our behalf, to provide new medicines and treatments for lung cancer patients.

My Story

Eleven years ago, I was at the peak of my career as a CEO when my world came crashing down around me. After 14 hours of surgery, a battery of nurses and doctors, an army of radiation and chemotherapy treatments, blood clots, procedures, and tubes, I lost my right lung to cancer. I am a survivor.

Today, we not only have new treatments; we have new surgical approaches; new medicines, and skilled, passionate researchers fighting for people with lung cancer; we have information, patient resources, and collaboration among patients, researchers, clinicians, and physicians. It is finally the century of patient-driven lung cancer research!

Throughout my diagnosis and treatment, I realized the huge unmet need for patient resources and information on lung cancer. Survival gave me a new goal: address a deficiency in lung cancer healthcare resources and research initiatives.

In 2006, my family and I founded the Bonnie J. Addario Lung Cancer Foundation (ALCF), where we work with patients to support research and advocate for innovative lung cancer medicines and treatments. In 2008, we started another nonprofit, Addario Lung Cancer Medical Institute (ALCMI), a global consortium dedicated to facilitating and driving research. We work with thousands of patients and families worldwide, providing free education and support programs, connecting patients with doctors and clinical trials, and funding innovative research where the need is greatest.

The Promise of Immunotherapy

Clinical research holds the key to discovering the causes of lung cancer, developing effective treatment options, and delivering those treatments to patients, in a timely manner. What can we do to predict lung cancer risk, detect the disease at early onset, and prevent it? Are there novel drug combinations to pre-empt and overcome cancer cells? How can we personalize and provide targeted treatment for each individual patient?

For the first time in decades, we have momentum and hope in the progress made with immunotherapy and companion drug trials. Timely approval and availability of breakthrough therapies allow more families to think of lung cancer survival in terms of years, not just months, and provide hope to make lung cancer a chronic, manageable disease by 2023. It can’t get more personalized than using your own immune system to fight your cancer!

Immunotherapy is a game-changer; a breakthrough that oncology desperately needs. Now, for the first time, we can begin to talk about long-lasting effects, even a cure. Unlike other therapies, immunotherapies afford a sustained, durable response that continues even after treatment is stopped—a first for diseases like lung cancer that have had poor prognoses.

This is a quantum leap forward—a moonshot. Before now, patients had limited options, especially after their disease progressed beyond the current standard of care therapies.

Unfortunately, immunotherapy does not work with every patient, every time. Approximately 70% to 80% of cancer patients do not respond to immunotherapy treatments, which may be an outcome of clinical trial design, including selection of the appropriate patient population.

Among patients who do respond to immunotherapy, not all have dramatic, long-lasting effects. Several patients present with pseudoprogression, meaning the disease appears to get worse before it gets better. Physicians, patients, and their caregivers need to be prepared for this to avoid discontinuing a potentially effective therapeutic regimen.

The Need to Redesign Clinical Studies for Maximal Benefit

On a broader level, we also need to examine clinical trial design in order to change the current dismal patient accrual rates of 3% to 5%. Clinical trial design needs an overhaul that would allow trials to be more inclusive, patient friendly, and easier to access, so that precious research dollars can be maximized to speed up the development of newer diagnostics, prognostics, and therapeutics. We need clinical trial data that is publicly available, so that it may advance the current state of lung cancer science and research, and inform the design of future clinical trials.

At ALCMI, we have successfully implemented a remote clinical study participation platform that allows young, lung cancer patients, from countries around the world—Italy, Turkey, Brazil, and New Zealand—to participate in the Genomics of Young Lung Study (GoYLC) trial¹ that is investigating mechanisms of tumor initiation and progression in patients under 40 years old. It is important that the field continues to change paradigms of how trials and studies are run, so that patients can look forward to better outcomes and more hope.

Not only do we need the clinical medicine ecosystem to change and adapt in order to bring newer treatments forward, we also need the patient to take a seat at the table, join clinical trials, and provide valuable data to drive faster cures.

Take Jeff Julian. Diagnosed in 2015, the 39-year-old former Olympic Trials finalist and Rose Bowl Aquatics head coach was shocked when he found out he had stage IV lung cancer. Because of his participation in a clinical trial for nivolumab, a breakthrough I-O drug, his tumors have significantly regressed and his disease is under control. Jeff knows, firsthand, that innovative treatments save countless lung cancer patients’ lives.

This year alone, more than 200,000 people in the United States received a lung cancer diagnosis.² Innovative medicines, like immunotherapy drugs, have and will save countless lung cancer patients’ lives. We need to continue to support the researchers and doctors pushing the envelope, and seeking new approaches and treatments to cure lung cancer.

Medical innovation works best when patients, donors, clinicians, pharma, biotech, payers, government, public, and private enterprise all take a seat at the table to collaboratively drive research. The lives of patients, around the world, are possible because of the stream of new research and novel drugs that help us fight lung cancer. It is a promising time for lung cancer patients and we are just getting started.

Personalized Medicine Should Lead the Way

Across the board, we see a heightened focus on precision medicine and personalized medicine, from President Obama’s Precision Medicine Initiative³ to the FDA’s Breakthrough Therapy and Fast Track approval process.⁴ Precision medicine empowers oncologists to test, profile, and target genomic mutations that cause cancer to grow and spread. Personalized medicine takes a step back and looks at the whole person, his or her age, medical history, ethnicity, and other factors that might influence treatment decisions.

As an advocate for personalized medicine, the ALCF has established 20 Centers of Excellence in community hospitals, nationwide, to ensure all patients receive genomic testing that can guide the treatments they receive. The ALCF also collaborated with 16 other lung cancer organizations on the Don’t Guess.Test. campaign⁵ to expand awareness and educate patients about the importance of comprehensive genomic testing in lung cancer, so that each patient receives the right treatment at the right time. We have created both, an online patient portal and an app for lung cancer patients; we fund research initiatives, such as the GoYLC study and the Clinical Trials Innovation Prize. We are working hard to move the dial to improve the 16% survival rate for lung cancer patients.

We now have an arsenal of new resources for lung cancer patients who are living well longer than previously imagined; yet, in the United States alone, 450 patients die from lung cancer every day.² Lung cancer is the top cancer killer of men and women, killing almost twice as many women, as any other cancers. It accounts for 27% of all cancer deaths and is the second leading cause of all deaths in the country.

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As a lung cancer patient and a patient advocate, I know the stakes have never been higher for patients waiting for new medicines that could improve treatment, save lives, and offer hope to families. Supporting, funding, and protecting the research and development of new medicines and new treatments is more critical, now than ever, to provide better treatments and better outcomes to all cancer patients. Patients deserve it.

Bonnie J. Addario is a stage IIIB lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation (ALCF) and the Addario Lung Cancer Medical Institute (ALCMI). For more information please visit www.lungcancerfoundation.org.References

1. Genomics of Young Lung Cancer study. Addario Lung Cancer Medical Institute website. http://alcmi.net/research/goylc-study/. Accessed January 12, 2016.
2. American Cancer Society. Cancer facts & figures 2015. http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf. Accessed January 12, 2015.
3. Fact sheet: President Obama’s Precision Medicine Initiative [press release]. Washington, DC: The White House; January 30, 2015. https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative.
4. Walia G. Breakthrough medicines usher in hopeful era for lung cancer patients. Bonnie J. Addario Lung Cancer Foundation website. http://www.lungcancerfoundation.org/patients/news/breakthrough-medicines-usher-in-hopeful-era-for-lung-cancer-patients/. Published December 18, 2015. Accessed January 7, 2016.
5. Don’t Guess Test website. http://www.dontguesstestlungcancer.com/. Accessed January 7, 2016.

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