A groundbreaking cancer ‘vaccine’ developed by a Yale University scientist has reversed the disease in nine patients.
All patients enrolled in the study between March 2019 and September 2021 were free from kidney cancer at the three-year follow-up in July 2023, marking a major milestone.
The type of kidney cancer they had – stages three and four clear cell renal cell carcinoma (ccRCC) – kills between 85 and 90 percent of patents.
The vaccine was able to snuff out the remaining cancer cells after surgery while avoiding healthy cells by being finely tuned to each patient’s biology.
The shots, developed by a team at the Yale Cancer Center and Dana-Farber Cancer, were designed to train the immune system to recognize only the specific mutations in a patient’s tumor that are not present in normal, healthy cells.
Dr David Braun, first author of the report and lead investigator at the Yale Cancer Center, said: ‘The idea behind this trial was to specifically steer the immune system toward a target that is unique to the tumor.’
Every case of cancer is unique, and researchers have been working to develop tumor-specific vaccines that can both destroy cancer cells in a highly targeted manner and prevent cancer from recurring, which happens to 20 to 50 percent of patients.
Their research is focused on this particular type of cancer, though if the shot proves efficacious in later studies, it could inform the way doctors in other specialties design theirs.
The phase one trial aimed to determine the vaccine’s safety and how well the patient’s bodies tolerated it.
All nine patients, each of whom received the vaccine, did not see their cancer return by the study’s end three years later.
Kidney cancer is the seventh most common type of cancer among men in the US and tenth most common among women.
Only around 10 to 15 percent of patients diagnosed with late stage ccRCC survive after five years.
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The latest study administered the vaccine to all nine participants.
Each patient received a total of seven doses of the vaccine during the study (5 doses during the priming phase and 2 during the booster phase).
Four patients received just the vaccine, and five others received small doses of the immunotherapy drug ipilimumab to evaluate how well the vaccine worked on its own, without the added influence of immunotherapy.
Adding small doses of ipilimumab helped researchers evaluate whether a low dose of this immunotherapy drug could enhance the vaccine’s effectiveness
Seven patients had stage three disease, and two had stage four.
All nine patients had an immune response to the vaccine, meaning it activated the body’s defenses.
The immune system was able to recognize and respond to up to 65 percent of cancer-causing mutations in patients’ tumors.
The vaccine uses small protein fragments that are designed to resemble cancer-specific proteins, known as neoantigens, which help the immune system recognize and target the cancer cells.
The study’s lead investigator, Dr. David Braun from Yale Cancer Center, explained that the trial aimed to guide the immune system to focus on a target specific to the tumor. For patients with stage III or IV clear cell renal cell carcinoma, the goal was to reduce the likelihood of cancer recurrence
Kidney and renal pelvis cancer affects 17.2 new cases and 3.4 deaths per 100,000 people annually. About 1.8 percent of people will be diagnosed with this cancer in their lifetime. As of 2021, an estimated 646,960 individuals were living with the disease in the US
The shots, developed by a team at the Yale Cancer Center and Dana-Farber Cancer, were designed to train the immune system to recognize only the specific mutations in a patient’s tumor that are not present in normal, healthy cells
Researchers sequenced the genetics of each patient’s tumors to identify their specific proteins, and peptides were synthesized in the lab to recognize them. Then, those peptides were pooled together to make the vaccine.
Patients who received the immune treatment and those who did not saw the same positive results, and no one experienced severe side effects other than flu-like symptoms after vaccination.
Dr Braun said: ‘This strong and durable activation in T cells was encouraging and indicates that we’re able to generate a long-lasting, anti-cancer immune response with the vaccine.’
Their findings were published in the journal Nature.
Trials with more patients will be needed to properly gauge its efficacy. Phase two trials are underway, in which a similar PCV will be administered in combination with the targeted therapy, Keytruda, also known as pembrolizumab.
While the early findings are far from decisive, they are invigorating for the world of oncology research, which has so far struggled to develop a cancer vaccine that can target a broader range of cancers and do so in the way that keeps cancer cells from sidestepping the immune system.
Renal cell carcinoma is among the 10 most common cancers worldwide, with more than 400,000 new cases diagnosed annually worldwide and about 80,000 new cases in the US. The highest rates of occurrence appear in the Western world and more often in men.
Older people, people who smoke, people with obesity, high blood pressure, and genetic conditions, and people with a family history of kidney cancer are more likely to get it.
Kidney cancer diagnoses have been rising steadily, from 6.82 new cases per 100,000 in 1975 to 15.75 in 2022, likely due to better detection, greater awareness, and lifestyle changes.
