Chloe Ramirez
Vaccines for lung cancer are being studied in new clinical trials, with the aim of stimulating the immune system to target and eliminate tumor cells. While lung cancer vaccines have been in development for over a decade, recent advances in immunotherapy and a greater understanding of the immune system have led to more promising results. One such vaccine, CIMAvax-EGF, has been proven safe and immunogenic in the treatment of patients with advanced non-small cell lung cancer (NSCLC) in several clinical trials. It is currently available in Cuba, Belarus, Colombia, Bosnia and Herzegovina, Peru, and Paraguay, and trials are being organized in the United States, the European Union, Japan, and Serbia. Roswell Park Comprehensive Cancer Center in Buffalo, New York, is the only U.S. institution with clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials with this immunotherapy. Other lung cancer vaccines in development include BNT166 and belagenpumatucel-L, which are in early-phase trials.
| Characteristics | Values |
|---|---|
| Vaccine Name | CIMAvax-EGF |
| Type | Immunotherapy |
| Mechanism | Blocks epidermal growth factor (EGF), a protein that cancer cells need to grow |
| Availability | Cuba, Belarus, Colombia, Bosnia and Herzegovina, Peru, Paraguay, US (only at Roswell Park Comprehensive Cancer Center in Buffalo, NY) |
| Eligibility | Patients with NSCLC stage IA to 3A at the initial diagnosis with no evidence of disease |
| Side Effects | Mild: chills, fever, feeling sick |
| Cost | Approximately USD $1 per shot to manufacture |
| Ongoing Trials | Phase I/II trial of CIMAvax-EGF in combination with nivolumab (anti-PD1 checkpoint inhibitor) for patients with advanced NSCLC |
| Other Vaccines in Trial | BNT116 (UK), LungVax (University of Oxford) |
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What You'll Learn
Roswell Park Comprehensive Cancer Center
The CIMAvax-EGF vaccine is a type of immunotherapy that stimulates the body's immune system to fight lung cancer. It works by blocking a type of protein called epidermal growth factor (EGF) that cancer cells need to grow. This prevents EGF from attaching to its receptor (EGFR) on the cell, thereby "starving" the cancer cells. Roswell Park initiated a Phase I/II clinical trial in 2017 to study the combination of CIMAvax-EGF with the anti-PD1 checkpoint inhibitor nivolumab (Opdivo®) in patients previously treated for advanced non-small cell lung cancer (NSCLC). Another trial is testing CIMAvax-EGF for lung cancer prevention in patients at high risk or to prevent recurrence.
To be eligible for the CIMAvax-EGF clinical trial at Roswell Park, patients must meet certain criteria. They should have received surgery or any adjuvant therapy for the initial diagnosis of lung cancer, completed at least three months prior to enrollment, although prior surgery or therapy is not required for eligibility. Patients should have confirmed NSCLC stage IA to 3A at the initial diagnosis and currently show no evidence of the disease. Additionally, eligible patients must be willing to undergo a complete screening period, including procedures such as bronchoscopy, pulmonary function tests, chest CT scans, and a complete physical examination.
Regarding lung cancer staging, Roswell Park provides detailed information on its website. Lung cancer stages are essential for determining treatment plans and understanding the extent of the disease. The TNM Staging System, developed by the American Joint Committee on Cancer (AJCC), assesses features such as the size of the original primary tumour (T), involvement of lymph nodes (N), and distant metastasis (M). For example, in Stage IIA, the lung tumour is no more than 3 cm across, but cancer cells are found in nearby lymph nodes. Accurate staging of lung cancer is crucial, and Roswell Park's Dr. Chukwumere Nwogu has received grants to investigate more effective methods for staging and postsurgical treatment options.
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CIMAvax-EGF
The vaccine works by blocking a type of protein called epidermal growth factor (EGF) that cancer cells need to grow. EGF is chemically linked to the Neisseria meningitidis outer protein P64k for immunogenicity. By raising antibodies against EGF, which is the epidermal growth factor receptor's (EGFR) major ligand, the concentrations of EGF in the blood are reduced. This, in turn, deprives cancer cells of the growth stimulus they require.
In Cuba, CIMAvax-EGF was approved as a "maintenance treatment for patients with stage IIIB/IV NSCLC" in 2014 and commercialization began in 2015. It has also been made available in several other countries, including Argentina, Belarus, Colombia, Bosnia and Herzegovina, Peru, and Paraguay. In the United States, Roswell Park Comprehensive Cancer Center in Buffalo, New York, is the only institution with clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials with this immunotherapy. These trials are currently open to eligible patients and are evaluating the effectiveness of CIMAvax-EGF in treating and preventing lung cancer.
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Clinical trials
For lung cancer vaccine clinical trials, there are several ongoing or upcoming studies at various institutions:
- Roswell Park Comprehensive Cancer Center, Buffalo, NY: They are conducting a Phase I/II clinical trial of the CIMAvax-EGF lung cancer vaccine, which was developed in Cuba. This trial combines CIMAvax-EGF with an anti-PD1 checkpoint inhibitor called nivolumab (Opdivo®) in patients previously treated for advanced non-small cell lung cancer (NSCLC). Roswell Park is the only institution in the US with FDA clearance to conduct CIMAvax clinical trials.
- UCLA: UCLA is conducting multiple lung cancer clinical trials in 2025. One of these trials is a Phase Ib/II study that investigates the combination of trastuzumab, necitumumab, and osimertinib for the treatment of stage IV NSCLC with EGFR mutations that are resistant to other treatments. Another UCLA trial is a Phase III study evaluating the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with clinical Stage I/II lymph node-negative NSCLC.
- UCSD: UCSD has several lung cancer clinical trials planned for 2025. One of these is a Phase II trial investigating the use of neoadjuvant and adjuvant atezolizumab, with or without tiragolumab, in combination with chemoradiotherapy for unresectable stage III NSCLC. Another UCSD trial is a Phase IIa study that evaluates the potential usefulness of leucoselect phytosome (LP), a special formulation of grape seed extract, for the pre-surgical treatment of early-stage lung cancer patients.
- UCSF: UCSF has several lung cancer clinical trials ongoing in 2025. One of these is a Phase III trial studying how well erlotinib hydrochloride works in treating patients with stage IB-IIIA NSCLC that has been completely removed by surgery. Another UCSF trial is a Phase II basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors, including NSCLC, that harbor specific gene fusions.
- Memorial Sloan Kettering Cancer Center (MSK): MSK is conducting various lung cancer clinical trials. One of their studies is a Phase 2 trial for TIL therapy to treat NSCLC. They are also testing the drug sotorasib as a first-line treatment in people with advanced lung cancer with the KRAS-G12C mutation.
- University of Oxford: Researchers at the University of Oxford have initiated the LungVax project, aiming to employ a vaccine to prevent the development of lung cancer in patients at high risk.
- BNT116 Vaccine Trial: A Phase 1 trial of the BNT116 lung cancer vaccine, similar to COVID-19 vaccines, is underway in the UK for patients with NSCLC. A Phase 2 trial is also mentioned, but the details are not provided.
It is important to note that clinical trials have specific eligibility criteria, and factors such as age, gender, the type and stage of the disease, past treatments, and other health conditions may determine whether an individual qualifies for a particular trial.
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Cancer prevention
Lifestyle Changes
Maintaining a healthy lifestyle is an important part of cancer prevention. This includes:
- A balanced diet: Eating plenty of fruits, vegetables, and whole grains while limiting processed foods and red meat can reduce the risk of various cancers.
- Weight management: Obesity is a risk factor for several types of cancer, so maintaining a healthy weight through diet and exercise is crucial.
- Physical activity: Regular physical activity can lower the risk of certain cancers, such as breast and colon cancer.
- Limiting alcohol consumption: Excessive alcohol intake is linked to an increased risk of various cancers, including liver and colorectal cancer.
- Avoiding tobacco: Tobacco use is a significant risk factor for lung, mouth, throat, and bladder cancer, among others. Quitting smoking and avoiding secondhand smoke can greatly reduce cancer risk.
Early Detection and Screening
Early detection of cancer can often lead to better treatment outcomes. Regular cancer screenings, such as mammograms for breast cancer, Pap tests for cervical cancer, and colonoscopies for colorectal cancer, can help identify cancer in its early stages when it is more treatable. Self-exams and being aware of any unusual symptoms or changes in the body are also important for early detection.
Preventive Medications and Vaccines
Certain medications and vaccines can help lower the risk of specific cancers:
- Chemoprevention: Some drugs, such as tamoxifen for breast cancer, can be used to reduce the risk in people with a high risk of developing certain cancers.
- Vaccines: Vaccines are being developed to prevent certain types of cancer. For example, the HPV vaccine can help prevent cervical cancer, and researchers are working on vaccines for lung cancer and other types.
Treatment of Pre-Cancerous Conditions
Treating pre-cancerous conditions can prevent them from progressing to cancer. This may include removing pre-cancerous lesions, such as actinic keratoses or certain types of polyps, or treating conditions like Barrett's esophagus or dysplasia, which can lead to esophageal or cervical cancer, respectively.
Stage II Cancer Treatment and Prevention of Progression
For individuals diagnosed with stage II cancer, the focus is typically on treating the cancer and preventing its progression to later stages. Treatment options may include surgery, radiation therapy, chemotherapy, hormone therapy, or a combination of these approaches. While there may not be a specific "vaccine" for stage II cancer, the goal of treatment is to eradicate the cancer and prevent recurrence. Maintaining a healthy lifestyle, regular follow-up care, and surveillance for potential cancer recurrence are all part of preventing cancer progression and improving long-term outcomes.
In summary, cancer prevention encompasses a range of strategies, from lifestyle modifications to early detection and the use of preventive medications or vaccines. For individuals with stage II cancer, the focus shifts to effective treatment and surveillance to prevent further progression and improve overall outcomes.
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Immunotherapy
In 2017, Roswell Park initiated a Phase I/II study of CIMAvax-EGF in combination with the anti-PD1 checkpoint inhibitor nivolumab (Opdivo®) in patients previously treated for advanced non-small cell lung cancer (NSCLC). Another trial is testing CIMAvax-EGF for the prevention of lung cancer in patients at high risk or to prevent recurrence. CIMAvax-EGF has also completed a Phase IV clinical trial for NSCLC in 2017 and is approved as a "maintenance treatment for patients with stage IIIB/IV NSCLC".
In addition to CIMAvax-EGF, other immunotherapies have shown promising outcomes in treating metastatic lung cancer. Durvalumab (Imfinzi), for example, has been approved by the FDA for treating stage 3 NSCLC that cannot be removed surgically and has not progressed after concurrent treatment with chemotherapy and radiotherapy. The approval was based on results from the PACIFIC clinical trial, which showed that durvalumab almost tripled the median time before disease progression compared to a placebo. Durvalumab works by releasing a brake on natural cancer-fighting immune cells called T cells, allowing them to destroy cancer cells.
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Frequently asked questions
CIMAvax-EGF is a lung cancer treatment that was developed in Cuba. It is a type of immunotherapy that uses the body's immune system to fight lung cancer. It is currently available in Cuba, Belarus, Colombia, Bosnia and Herzegovina, Peru, and Paraguay.
Roswell Park Comprehensive Cancer Center in Buffalo, New York, is the only U.S. institution with clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials with this immunotherapy. To qualify for the trial, you must have received surgery or any adjuvant therapy for the initial diagnosis of lung cancer, completed at least 3 months prior to enrollment. The cancer must be confirmed as NSCLC stage IA to 3A at the initial diagnosis, with no evidence of disease.
Vaccines for the prevention and/or treatment of non-small cell lung cancer (NSCLC) are being studied in new clinical trials. Another lung cancer vaccine, BNT116, is a messenger RNA vaccine that works by stimulating the immune system with tumor markers from NSCLC. An early-phase trial (phase 1) has recently started in the UK, treating patients with NSCLC.
