On August 8, at the 21st World Congress on lung cancer, Professor Zhang Li, from the center for cancer control and prevention of Sun Yat sen University, released the results of a three-phase, double-blind, randomized controlled trial on the first-line treatment of advanced non-small-cell lung cancer. The data showed that the immune combined chemotherapy regimen significantly delayed the disease progression of patients with advanced NSCLC, and the risk of tumor progression was reduced by 52%.
this is one of the three clinical studies selected by the Organizing Committee and released in the form of oral reports. It is also the only study on PD-1 combined chemotherapy. This achievement has also been selected by the famous international journal of lung cancer, and published online on the same day by means of a fast track. This shows that the scientific and advanced research content is expected by the industry.
Professor Zhang introduced that cancer treatment can be achieved through surgery in the early stage, while patients in the late stage can only choose chemotherapy, targeted therapy or immunotherapy. In recent two years, immunotherapy, especially the clinical research of immunosuppressive checkpoint inhibitors, is a worldwide hotspot. According to data released by the National Cancer Center in 2019, the incidence rate and mortality rate of lung cancer in China ranks first among all cancers, according to
data released by the National Cancer Center. There are different types of lung cancer, among which non-small cell lung cancer accounts for about 80% to 85%, of which about 70% of patients are not suitable for radical surgery for locally advanced or metastatic lung cancer at the time of diagnosis. At the same time, a considerable proportion of patients with early non-small cell lung cancer undergoing surgical treatment will have recurrence or distant metastasis, and then die of disease progression. About 70% of non-small cell lung cancer patients in China are non squamous non-small cell lung cancer. Nearly 50% of the patients have no EGFR sensitive mutation or ALK gene rearrangement, which is not suitable for targeted therapy. Therefore, there is a huge unmet clinical demand.
the research led by Professor Zhang Li is the first double-blind, randomized, controlled phase III clinical study on the first-line treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) with immunochemotherapy in China. Dabashu combined with chemotherapy is compared with chemotherapy alone in the first-line treatment of such patients. The study was conducted in 48 hospitals across the country, with a total of 397 patients recruited. The study was enrolled from August 2018 to July 2019.
“the current research results show that patients who are not suitable for targeted therapy can be treated with immune combined chemotherapy, and the results of combined drug therapy are significantly better than those of chemotherapy alone.” Professor Zhang said.
the patients were randomly divided into two groups, one group was treated with dabetaxel combined with chemotherapy, the other group was treated with chemotherapy alone. According to the interim analysis conducted by the independent data Committee, as of November 2019, the median progression free survival time of the combined immunochemotherapy group was 8.9 months, that is, nearly 9 months from the beginning of treatment, and the data of chemotherapy alone group was only 5 months. The results showed that the risk of progression was reduced by 52% in the combined treatment group, and the safety characteristics were consistent with previous studies.
Professor Zhang said that the median overall survival time of the two groups is still under observation, but the current data seems to be very optimistic: “previous historical data show that the one-year survival rate of this kind of patients with chemotherapy alone is about 40% – 50%, but in this study, as of the mid-term analysis, about 80% of the patients in the combined treatment group are still alive, and the one-year survival rate is close to 70%. Immunotherapy has a so-called tailing effect, which takes longer once the patient benefits. The clinical trial was completed in July 2019. At present, in the continuous follow-up, it will take 1-2 years to report the two-year survival rate, and 3-5 years to report the five-year survival rate. But from now on, this result is obviously better than chemotherapy alone
it is understood that immunotherapy is a hot research field in the field of cancer treatment in recent years after chemotherapy, radiotherapy and targeted therapy. PD-1 inhibitors have attracted much attention in the field of immunotherapy and are suitable for many kinds of cancer.
Professor Zhang explained the treatment mechanism. In short, a special protein PD-L1 will be produced on the surface of cancer cells. When it is combined with PD-1 on the surface of immune cells, it will make immune cells produce “illusion” and lose the ability to kill cancer cells. The role of PD-1 inhibitors is to “insert a foot” between the two, so that PD-1 and PD-L1 can not bind, so that immune cells can recover the role of recognizing and killing cancer cells.
dabesu, a domestic PD-1 inhibitor used in this clinical study, was conditionally approved in China in January 2018 for recurrent or refractory classical Hodgkin’s lymphoma. It is the first Chinese immunotherapy product published in an authoritative medical journal. In November 2019, dabashu became the only PD-1 inhibitor to enter the new national health insurance catalogue. At present, the medical community is trying to expand the scope of its indications, carrying out a total of more than 20 clinical studies worldwide.
“in recent years, the pace of pharmaceutical innovation in China has accelerated. More and more clinical data are published in top medical journals and presented in international academic conferences. We hope that these drugs with positive clinical results will be approved and marketed as soon as possible to benefit more ordinary cancer patients. ” Tension. (for more news, please pay attention to Yangcheng school