LONDON (AP) — An international clinical trial testing a new cancer immunotherapy that prevents skin cancer from recurring has recruited its first patient in Britain this week.
The mRNA-based technology, the same vaccine technology used for some COVID vaccinations, is being targeted at people who have already had high-risk melanoma – the most serious of cancers – removed.
For the trial, doctors at University College London Hospitals (UCLH) are giving Eye along with another drug, pembrolizumab or Keytruda, which also helps the immune system kill cancer cells.
One of the first patients to sign up for the trial is British musician Steve Young, 52, from Hertfordshire, eastern England, who was diagnosed with Stage I melanoma, which was removed.
“I feel fortunate to be a part of this clinical trial.Of course, when I was diagnosed with skin cancer I wasn't feeling lucky, in fact, it was quite a shock but now that I've had treatment, I'm keen to make sure it doesn't happen again. yes. Young said, this is my best chance to stop cancer in its original form.
The personalized treatment works by instructing the body to make 3 proteins, each targeting a "neoantigen" identified by gene sequencing and however causing cancer in that particular patient. Neoantigen proteins are found only on cancer cells, and personalized neoantigen therapy is designed to prime the immune system to attack the tumor cells in each patient, while Keytruda blocks an immunological “brake” that slows the cancer down. Protects.
"The idea behind this immunotherapy is that, by prompting the body to make the protein, it will cause the immune system to quickly identify and attack cancer cells, with the aim of preventing the recurrence of melanoma," said the medical oncologist at University College London. Can prepare to attack." Heather Shaw, national coordinating investigator of the new trial.
The new Phase 3 clinical trial, led by UCLH, is evaluating the combination of mRNA-4157 (V940) and Keytruda (pembrolizumab) versus current standard of care (pembrolizumab), as a risk-reducing treatment option for high-risk patients. Is in the form. Risk, stage IIB to IV melanoma.
It follows a successful Phase 2 study, which found that in patients with stage IIIB to IV resected melanoma, this treatment option improved survival after three years compared with Keytruda treatment alone in patients with advanced melanoma after surgical removal. The risk of cancer recurrence or death was almost halved. of cancer.
Melanoma is characterized by uncontrolled growth of pigment-producing cells.Rates of melanoma have been increasing over the past few decades, with approximately 3,25,000 new cases reported worldwide in 2020. In the UK, melanoma is the fifth most common type of cancer. , approximately 8,400 new cases are reported every year.
The mRNA technology was developed by Moderna in collaboration with Merck Sharp N Dohme (MSD), using lessons learned from COVID research developments and was expected to contribute to new treatments for cancer patients.
Researchers are now hoping that the Phase 3 study, which is ongoing at multiple sites across the UK, will confirm the findings of the earlier trial.The phase I trial, named INterpath-001, will enroll about 1,089 patients worldwide. The primary outcome measure is recurrence-free survival, with overall survival and metastasis-free survival as secondary outcomes.
V940-001 is a Phase 3 global, randomized, double-blind, placebo-active-comparator-controlled study. This means Steve Young knows he is getting Keytruda, but he won't know whether he is getting personalized cancer treatment or a placebo.
The mRNA-based technology, the same vaccine technology used for some COVID vaccinations, is being targeted at people who have already had high-risk melanoma – the most serious of cancers – removed.
For the trial, doctors at University College London Hospitals (UCLH) are giving Eye along with another drug, pembrolizumab or Keytruda, which also helps the immune system kill cancer cells.
One of the first patients to sign up for the trial is British musician Steve Young, 52, from Hertfordshire, eastern England, who was diagnosed with Stage I melanoma, which was removed.
“I feel fortunate to be a part of this clinical trial.Of course, when I was diagnosed with skin cancer I wasn't feeling lucky, in fact, it was quite a shock but now that I've had treatment, I'm keen to make sure it doesn't happen again. yes. Young said, this is my best chance to stop cancer in its original form.
The personalized treatment works by instructing the body to make 3 proteins, each targeting a "neoantigen" identified by gene sequencing and however causing cancer in that particular patient. Neoantigen proteins are found only on cancer cells, and personalized neoantigen therapy is designed to prime the immune system to attack the tumor cells in each patient, while Keytruda blocks an immunological “brake” that slows the cancer down. Protects.
"The idea behind this immunotherapy is that, by prompting the body to make the protein, it will cause the immune system to quickly identify and attack cancer cells, with the aim of preventing the recurrence of melanoma," said the medical oncologist at University College London. Can prepare to attack." Heather Shaw, national coordinating investigator of the new trial.
The new Phase 3 clinical trial, led by UCLH, is evaluating the combination of mRNA-4157 (V940) and Keytruda (pembrolizumab) versus current standard of care (pembrolizumab), as a risk-reducing treatment option for high-risk patients. Is in the form. Risk, stage IIB to IV melanoma.
It follows a successful Phase 2 study, which found that in patients with stage IIIB to IV resected melanoma, this treatment option improved survival after three years compared with Keytruda treatment alone in patients with advanced melanoma after surgical removal. The risk of cancer recurrence or death was almost halved. of cancer.
Melanoma is characterized by uncontrolled growth of pigment-producing cells.Rates of melanoma have been increasing over the past few decades, with approximately 3,25,000 new cases reported worldwide in 2020. In the UK, melanoma is the fifth most common type of cancer. , approximately 8,400 new cases are reported every year.
The mRNA technology was developed by Moderna in collaboration with Merck Sharp N Dohme (MSD), using lessons learned from COVID research developments and was expected to contribute to new treatments for cancer patients.
Researchers are now hoping that the Phase 3 study, which is ongoing at multiple sites across the UK, will confirm the findings of the earlier trial.The phase I trial, named INterpath-001, will enroll about 1,089 patients worldwide. The primary outcome measure is recurrence-free survival, with overall survival and metastasis-free survival as secondary outcomes.
V940-001 is a Phase 3 global, randomized, double-blind, placebo-active-comparator-controlled study. This means Steve Young knows he is getting Keytruda, but he won't know whether he is getting personalized cancer treatment or a placebo.
