Developing the First Vaccine for Treating ALK-Positive Lung Cancer

Juhi Kunde, MA, LUNGevity Science Writer
Dr. Mark Awad
Dr. Mark Awad

Approximately 5% of non-small cell lung cancer patients have tumors resulting from the fusion of the ALK gene with another gene (usually EML4). While there are a number of tyrosine kinase inhibitors (TKIs) approved to treat ALK-positive lung cancers, the cancer is likely to recur because of the development of resistance to them.

“In many types of lung cancer, immunotherapy, which harnesses the body’s natural ability to fight illness, is a useful treatment option. However, for ALK-positive patients, the immunotherapies that are currently available have not shown significant benefits,” explains Mark Awad, MD, PhD, clinical director of the Lowe Center for Thoracic Oncology Treatment Center at the Dana-Farber Cancer Institute in Boston. “We needed a different approach to help ALK-positive patients.”  

Working with a close collaborator, Roberto Chiarle, MD, associate professor in the Department of Pathology at Boston Children’s Hospital, Dr. Awad was excited to learn that some ALK-positive lung cancer patients have immune systems that recognize the tumors as something the body needs to fight. “It meant that we could use that to our advantage. We could find a way to rev up the body’s natural immune system to not just “see” the tumor, but to also attack it,” says Dr. Awad.

Using mouse models, the researchers demonstrated that it was possible to use a vaccine to amplify the natural immune response against ALK-positive tumors. The researchers also saw improved outcomes when combining the vaccine with TKI therapies in mice.

With a 2018 LUNGevity research grant funded by ALK Positive, a patient advocacy group dedicated to advancing research and advocacy to change the future of ALK-positive lung cancer, Drs. Awad and Chiarle are developing a therapeutic vaccine that could improve the survival rates for ALK-positive lung cancer patients.

Similar to a flu shot, the vaccine introduces pieces of the mutated ALK protein into a patient’s body. These protein pieces are carefully selected to prepare the immune system to fight any cells with the mutated ALK protein. The immune cells then circulate through the body looking for and killing any cells that have the mutated ALK protein.

Because the mutated ALK protein is only found in cancerous cells, the researchers expect that side effects for patients using the therapeutic vaccine will be minimized. “We are hopeful that patients will be able to tolerate this treatment quite well. Of course, we won’t know for sure until we conduct the phase 1 clinical trial to confirm the safety of the treatment,” notes Dr. Awad.

The research team’s next steps are to manufacture the vaccine and then begin the clinical trial (which will include about 20-25 patients) to demonstrate that the vaccine is safe for ALK-positive lung cancer patients. Because manufacturing the vaccine and conducting the clinical trial are expensive (it will cost approximately $750,000 to manufacture the vaccine and another $1 million to conduct the clinical trial), the researchers are discussing potential partnerships with pharmaceutical companies to manufacture and test the vaccine quickly and efficiently.

Drs. Awad and Chiarle are on the cusp of getting this vaccine to patients. They continue working to optimize the protein pieces chosen for the vaccine, improve their plan for the clinical trial, and acquire the necessary funding to begin the clinical trial as soon as possible.

“I am so impressed, and so grateful, for all the patients and their family members in advocacy groups, such as ALK Positive and LUNGevity, for their efforts,” said Dr. Awad. “By participating in clinical trials, providing biopsy and blood samples, and educating themselves and others, these groups have helped advance the field. Their involvement is really making a difference.”


Related Reading:

Juhi Kunde, MA, is a science writer for LUNGevity. Juhi Kunde

Blog category: 
From the experts
-> Biomarker testing
-> Lung cancer types
-> Treatment


I am a 67 year old non smoker with NSCLC. I am 100%ALK POSITIVE. I have been on ALECENSA for almost 2 years with excellent results. I had malignant lymph nodes in mediastinum, in both sides of neck, and under left arm. Recent CAT SCAN —- NO EVIDENCE OF DISEASE!! Am due for CAT SCAN November 11.

Very exciting development. This is great example of passionate researchers working in collaboration with patients group.

How can patients enrole in this clinical trial? Is there somewhere to sign up for wanting to participate?

Hello Iselin.  LUNGevity has tools to help determine if a clinical trial is right for a lung cancer patient. You can learn more about how to find clinical trials by checking out Clinical Trials 101 or the Clinical Trial Finder. After reviewing these resources, it’s best to talk to the treating physician about different options. You can also use questions listed here to start a discussion with the treating physician.

Add new comment