On April 29, Roche's innovative tumor immune drug Tecentriq® (common name: atelizumab) combined with chemotherapy for first-line treatment of extensive-stage small cell lung cancer was officially launched in China The first indication for Tecentriq®® to be approved and listed in China. On February 13 this year, China's State Drug Administration formally approved Tecentriq® combined chemotherapy for first-line treatment of a wide range of small cell lung cancer, marking Roche's formal entry into the field of tumor immunotherapy in China. Since then, there is no longer any medicine to cure, breaking the 30-year "drug shortage" dilemma.
· Tecentriq® (English name: Tecentriq®, common name: atezolizumab) combined chemotherapy is the first in the world, and currently the only one in China approved for first-line treatment of extensive stage small cell lung cancer therapy.
Tecentriq® is also the first innovative drug proven to bring significant benefits to patients with small cell lung cancer in more than 30 years.
Urgent clinical needs, the current status of patient survival needs to be improved
Malignant tumors have become one of the major public health issues that seriously threaten the health of the Chinese population. According to the 2017 "Current Situation and Trends of Cancers in China" report, lung cancer has ranked first in the incidence of malignant tumors in China for 16 consecutive years. In 2015, the number of deaths from lung cancer in China was about 631,000, and the mortality rate was 45.87 per 100,000. In recent years, the incidence of lung cancer is still increasing year by year, and it is showing a younger trend.
According to the pathological type, lung cancer can be divided into non-small cell lung cancer and small cell lung cancer. Small cell lung cancer accounts for about 15% of lung cancer. It is a highly invasive and rapidly proliferating malignant tumor. The prognosis of patients with small cell lung cancer is extremely poor. Two thirds of patients have already reached the extensive stage at the time of first diagnosis, that is, distant organ or lymph node metastasis has occurred at the time of disease detection. The 5-year average survival rate after diagnosis is only 2%.
The vice chairman of the Chinese Society of Clinical Oncology (CSCO), the chairman of the CSCO small cell lung cancer professional committee, and Professor Cheng Ying of the Jilin Provincial Cancer Hospital introduced: "Small cell lung cancer is the most invasive subtype of lung cancer. Difficult symptoms and persistent cough and other symptoms are often metastasized when they come to the doctor. Etoposide combined with platinum-based chemotherapy is still the standard first-line treatment for extensive small-cell lung cancer for more than 30 years. Although most patients receive remission after initial treatment, However, drug resistance recurs quickly, and there is a lack of effective treatment after relapse, so the 5-year survival rate of extensive small cell lung cancer is very low. "
Innovative immunotherapy "breaks the situation", bringing greater benefits to patients
Tecentriq® (Atilizumab) combined with chemotherapy for the first-line treatment of a wide range of small cell lung cancer was approved for marketing, mainly based on the results of the IMpower133 trial of a global multi-center phase III clinical trial. The trial enrolled 403 patients with extensive-stage small-cell lung cancer and were randomly divided into two groups to compare the efficacy and safety of combined treatment with Tecentriq® (atelizumab) and single chemotherapy for small-cell lung cancer.
The study showed that Taishengqi® (Atilizumab) combined with chemotherapy can significantly reduce the risk of disease progression and death (PFS = 5.2 vs 4.3 months; HR = 0.77, 95% CI: 0.62-0.96; p = 0.017), the study also suggests that Taishengqi (Atelizumab) combined with chemotherapy can bring long-term benefits to patients with small cell lung cancer. During the 13.9-month follow-up, the proportion of patients in the experimental group who found continuous remission of the disease was 3 times that of the chemotherapy group (15% vs. 5%). During the longer follow-up, Taishengqi Monoclonal antibody) combined with chemotherapy, 1/3 of patients survived more than 18 months, compared with 21% in the chemotherapy group, there was a significant increase. In terms of safety, the performance of Tecentriq® combined with chemotherapy group is consistent with the previous safety of Tecentriq®.
Professor Cheng Ying said: The IMpower133 study is the first phase III study of immunotherapy in the first-line treatment of extensive-stage small cell lung cancer. China also contributed 100 patients in this study. Studies have shown that the median survival of the Taishengqi® combination chemotherapy group is 12.3 months. Compared with standard chemotherapy, Tecentriq® combination chemotherapy can significantly prolong the overall survival of patients with extensive-stage small cell lung cancer and reduce the risk of death. The IMpower133 study is the first phase III study in 30 years to achieve a median improvement in the systematic treatment of patients with extensive-stage small cell lung cancer. The listing of Taishengqi means that China's small cell lung cancer has officially entered a new era of immunization.
Tecentriq® is an innovative monoclonal antibody independently developed by Roche for tumor immunotherapy. Unlike tumor immunotherapy specifically for PD1, Tecentriq® not only prevents the binding of PD-L1 to the PD-1 receptor, but also prevents it by binding to the PD-L1 protein on the surface of tumor cells and the surface of tumor-infiltrating immune cells. The combination of PD-L1 and B7.1 receptors not only helps the human immune system recognize tumor cells, but also further activates human immune system T cells to attack tumor cells.
With the listing of Tecentriq® in China, it marks that Roche will achieve full coverage in the field of lung cancer treatment in China and provide comprehensive lung cancer individualized treatment options for Chinese lung cancer patients:
· Trokai® (generic name: erlotinib hydrochloride) for the treatment of EGFR gene mutations in non-small cell lung cancer
· Anti-angiogenic drug Avastin® (generic name: bevacizumab)
· ALSA positive for the treatment of locally advanced or metastatic non-small cell lung cancer with ALK positive (common name: alectinib)
· Innovative tumor immunotherapy drug Tecentriq® (generic name: atelizumab) for the treatment of extensive-stage small cell lung cancer
In addition, Roche is also conducting phase III clinical research on rare targets of lung cancer, such as NTRK and ROS1, to further promote individualized treatment of lung cancer.