Breakthrough! Breast Cancer Vaccine GP2's latest study finds no recurrence in 5 years after HER2-positive breast cancer surgery!

The standard treatment for HER2-plus breast cancer is curvature and pato-pearl monoantigen.
Of course, at least nine drugs have been approved worldwide for the treatment of HER2 plus breast cancer, in addition to queto-bead monoanti and pato-bead monoanti, Rapatini, T-DM1, nairatini, python, DS-8201, Takatini, and Phesgo (Patoju single-resistance/queto-pearl monoantigen/hyalonidasexf), which was approved in June this year.
these drugs, which give HER2 breast cancer patients a clear therapeutic effect and more treatment options.
Even so, under the existing treatment options, one in eight women is still affected by relapsed breast cancer, about 50% of women with relapsed breast cancer do not respond to drugs such as curtojudan, resulting in metastasis breast cancer and poor prognostication, 80 to 85% of metastasis breast cancer patients can not survive.
9, 2020, at the prestigious San Antonio Breast Cancer Conference, a study shocked the world! A cancer vaccine called GP2, so that breast cancer patients 5 years recurrence rate of zero, can be called a clinical cure! This comes from a Phase IIb clinical trial, which is a forward-looking, randomized, placebo-controlled, single-blind, multi-center clinical study.
: 168 patients were included at 16 clinical points, randomly divided into two groups: receiving GP2 plus GM-CSF and using GM-CSF alone.
, there were 96 cases of HER2 3 plus patients who received terroid bead monoantial therapy after surgery in the combined GP2-GM-CSF or individual GM-CSF.
results: After 5 years of follow-up, 46 herr2 plus breast cancer patients treated with GP2-GM-CSF had a 100% 5-year DFS incidence, compared with 59.4% of 50 placebo patients treated with GM-CSF.
from the following survival curve graph, popularly available, the treatment group from the beginning of treatment, to 5 years after treatment, all patients do not relapse! So what you see is a straight line.
, the GP2 group of HER2 plus breast cancer patients are likely to be "cured" in this way, I believe that with the longer follow-up time, the effect may continue longer.
: In terms of security, GP2 does not have SAEs (severe adverse events) and exhibits good tolerance.
GP2 passed local skin and immune tests and obtained a strong immune response, indicating that the peak of immunity was reached six months after the completion of PIS.
results suggest that patients with HER2-plus breast cancer will be the first to be "cured" after surgery and curvature monotherapy, and then receive GP2-GM-CSF treatment.
synergy between the GP2-GM-CSF and the curvature bead monoant.
fact, a study published in April found no clear benefits in the treatment of HER2-positive breast cancer patients with both AE37 and GP2 vaccines.
article was published on Breast Cancer Res Treat.
AE37 and GP2 are HER2-derived peptide vaccines.
AE37 mainly triggers CD4 responses, while GP2 triggers CD8 responses for HER2 antigens.
these peptides were tested in a large randomized trial to assess their ability to prevent recurrence in breast cancer patients who expressED HER2.
analysis found no difference in total disease-free life (DFS) of 5 years, but subgroups may benefit.
: In this 4-arm, forward-looking, randomized, single-blind, multi-center Phase II clinical trial, patients with non-positive lymph nodes and high-risk lymph node-negative breast cancer received standard treatment.
vaccine (VG) is given six times a month relative to the control (CG), and as the main vaccine series, is given four times every six months.
demographics, safety, immunology and DFS data were evaluated.
results: 456 patients were selected; AE37 was selected for 154 patients in VG, 147 in CG, 89 in GP2 and 91 in CG.
DFS in the AE37 group was no different from the CG, but a pre-existing exploratory subgroup analysis showed a trend towards benefits in the later stages (p s 0.132, HR 0.573 CI 0.275-1.193), HER2 under-expression (p s 0.181, HR 0.756 CI 0.499-1.145) and triple negative breast cancer (p . . . 0.266, HR 0.443 CI 0.114-1.717).
, HER2 under-expression and late-stage patients benefited significantly from VG (p . . . 0.039, HR 0.375 CI 0.142-0.988).
there was no significant difference in DFS in the GP2 group compared to CG, but in the subgroup analysis, THERE2-positive patients did not relapse, and VG DFS showed an improved trend compared to CG (p s 0.052).
fact, patients with HER2 over-expression who received the GP2 vaccine had a 5-year estimated trend of significant improvement in DFS compared to the control group (100% vs 87.2%, p s 0.052, Figure 3c).
conclusions were consistent with the study, i.e. in her2-positive patients, 5-year DFS was also 100%, and the control group was similar.
, there was no significant difference in statistics and was the result of subgroup analysis.
GP2 final 5-year-year-old indexed disease-free survival a Intention to Treat b Per-treatment c Per-treatment subset of HER2 Over-expressing breast cancers concluded that this Phase II clinical trial has shown that AE37 and GP2 are safe and may be associated with improved clinical outcomes in some breast cancer patients in subgroup DFS.
these findings, the combined and/or individually given AE37 and GP2 vaccines can be further evaluated based on the biological characteristics of the disease in breast cancer patients.
, Mays believes the two studies are different.
this study is optimized for use, using GP2 plus GM-CSF, which may have synergies and produce better results.
that vaccines are not available, but that they need to be treated in a properly combined treatment.
, research design is important, and the newly published study focuses solely on her2 plus breast cancer, which is key.
cancer vaccine is used to awaken the body's cancer-fighting immune system by using antigens associated with tumor cells.
A U.S. Food and Drug Administration (FDA) advisory board voted unanimously to allow Merck's cervical cancer vaccine to go on sale, meaning the human fight against cancer is entering a landmark new phase.
In addition to HPV, there are a number of vaccines that have been on the market for years, such as Japan's Hasumi Vaccine, even though the huge clinical trial costs in various countries have not been approved by the FDA.
, however, people would most like to see more than just a vaccine against cancer, in fact the cervical cancer vaccine is exactly the HPV vaccine, which prevents this viral infection and thus reduces the incidence of cervical cancer.
, however, once HPV has been infected, or cervical cancer has occurred, such a vaccine is still ineffective.
then, is there a "therapeutic vaccine", that is, already suffering from cancer, can still be treated with a vaccine? It has been explored for the first 20 years, but with little success.
some preliminary research results have emerged.
developed a vaccine at Harvard University's Institute of Biological Research.
this time the new anti-cancer vaccine is mainly aimed at three-negative breast cancer.
found in animal studies that 100 percent of the injected mice survived.
and did not relapse or metastasis.
by directly injecting the vaccine at the tumor site, the vaccine was found to activate the body's immune system, leading to cancer cell death.
, PD-1 vaccine PD1-Vaxx activates both B-cell and T-cell functions to promote tumor removal.
, the goal of the treatment is to block signaling path paths that are critical to tumor growth and maintenance.
, the U.S. Food and Drug Administration approved PD1-Vaxx to enter the first phase of human trials in the United States, which will focus on patients with non-small cell lung cancer.
earlier this year, Australian authorities also approved the start of the first phase of the trial there.
the realization of the breast cancer vaccine needs to have two conditions: one is to have a suitable and efficient antigen delivery system, and the other is to have sufficiently specific and efficient antigen.
antigen delivery is mainly carried out by four methods, such as synaptic cells, whole tumor cells, peptide-related antigens and viral protons.
1. Dexter cell vaccine: dexterous cells are the most promising antigen delivery cells known, it is widely found in exosome tissue, mature dexterous cells can break down antigens into several peptide fragments, and peptide fragments presented to the original T cells, producing CD4 auxiliary T cells and CD8T cells mediated cell immunity;
tree protrusion cell vaccine is first necessary to obtain dexterity cells from the patient's body, mature them in vitro and expose them to tumor antigens for identification, and then inject the dexterity cells that recognize tumor antigens into the patient's body to activate the immune system.
currently in the study of dendritic cell vaccine Her-2 point autoimmune vaccine and P53 vaccine, its Phase I clinical trials have been completed, has entered the Phase II clinical trial stage.
Her-2 dot autoimmune vaccine is a vaccine that enables dendritic cells to identify Her-2 peptide E75 and E90 fragment antigens, and to vaccinate her-2 over-expression metastasis breast cancer in the treatment of yew alcohol and Herceptin, and to compare the comprehensive treatment of Noviben and Herceptin with the vaccine-free group; A trial enabled dendrites to identify peptide fragments of the P53 wild gene antigen and then make a vaccine to treat metastatic breast cancer with P53-positive, HLA-A2, and advances in first-line endocrine therapy.
It should be noted that the immunogenicity applied to cancer patients has been confirmed after the in-body identification of antigens, but the progenitor vaccine requires higher production conditions and the current experimental effect on its treatment of transsexual solid cancer is different.
2. Peptide vaccine: Peptide vaccine construction is relatively simple, tumor-related antigen polypeptide fragments are easy to mass production and purification, they are combined with antigen delivery cells (APC cells) or T cells to play their immunogenicity, induce cellular immunity and body fluid immunity.
people increase their molecular weight by increasing amino acids, or by applying immuno adulents simultaneously to improve their immunogenicity.
-macrophage cloning stimulation factor (GM-CSF) promotes antigen delivery and enhances vaccine-induced T-cell effects, thus enhancing vaccine efficacy.
Current vaccine trials have focused mostly on Her-2-related peptide vaccines, and a Phase II study used Her-2-related antigen peptides GP2 and AE37 as vaccines for high-risk patients who did not relapse after standard treatment, comparing vaccines with GM. Efficacy of the CSF group and the individual GM-CSF group.
another Phase II. study was a polypeptide vaccine for Her-2 intracellular antigen (intracellar domain, ICD) in patients with no metastasis or IV. phase III.B/1IIC with only stable bone metastasis.
Disis and others confirmed that in the phase I study of the study, all 11 patients developed T-cell reactions to the polypeptide vaccine, and 7 of them produced T-cell reactions at Her-2 bits other than the polypeptide vaccine.
five years of observation confirmed the continued existence of immunity.
also demonstrated the safety of the vaccine when applied in the same time as Hersatin.
3. Whole Tumor Cell Vaccine: Self-Full Tumor Cell Vaccine 3. Whole Tumor Cell Vaccine: Self-Full Tumor Cell Vaccine is the earliest vaccine preparation route, it has all the antigens of the tumor, theoretically can produce multiclonal immune response, and targeted individual tumor patients.
Whole tumor cells are obtained through the isolation of patient's own tumor cells or by known allogeneic cell line, the whole tumor cells have specificity for individual patients, and allogeneic cells are specific to breast cancer cells. There is currently a Phase II clinical trial for Her-2-positive underarm lymph nodes or advanced breast cancer, using Hercetin, cyclophosphamide, GM. CSF secreted whole-cell vaccine combination, compared with the vaccine-free group, and another trial was Her-2 negative advanced breast cancer, using Hercetin, cyclophosphamide, GM. CSF secretion-type whole-cell vaccine combination, compared to the Hersheytin-free group.
Although whole tumor cells can provide a large number of tumor cell surface specific antigens, but a large number of autologic tumor cell acquisition, the immunogenicity of many antigens in the specific antigen is not effective assessment method is insufficient.
because of the presence of a large number of normal cell antigens on the surface of the whole-cell vaccine, it may lead to immune tolerance and reduce the efficiency of the identification of tumor-specific antigens, the use of immuno-adulations is required.
4. Virus vector vaccine: through the gene transductivity and immunogenicity of the virus, the virus vector vaccine can be prepared.
virus vector vaccine with specific antigen gene fragments enters the human body, it can infect antigen delivery cells (APC cells) and make them express tumor-related resistance encoded by antigen genes in viral vector vaccines