It has to be said that lung cancer patients in China have caught up with an unprecedented good era. September just welcomed the 10th immune drug. Just one month later, the 11th immune checkpoint inhibitor was launched on the market, injecting new strength into the front-line treatment of lung squamous cell carcinoma patients!
On October 31, 2022, the official website of the National Medical Products Administration (NMPA) announced that the new indication for domestically produced PD-1 inhibitor slulizumab (trade name: Hans-shaped, H-drug) was approved, and combined with carboplatin and albumin paclitaxel is used for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). It is worth mentioning that this is the second indication approved by H drug in China and the 11th immunotherapy approved for non-small cell lung cancer in the world.
progression-free survival time hits a new high! Patients with lung squamous cell carcinoma usher in the "first-line" vitality
For the non-small cell lung cancer patient population in China, lung adenocarcinoma has more treatment options than lung squamous cell carcinoma, because lung adenocarcinoma often has various mutations and there are many targeted drugs to choose from. The current main treatment plan for patients with lung squamous cell carcinoma is chemotherapy + immunity. The approval of this time undoubtedly adds a "first-line" chance for patients with lung squamous cell carcinoma with limited treatment plans. The approval of the new adaptation of
Slulizumab is based on outstanding clinical data from a global multicenter Phase III study codenamed ASTRUM-004. It is also worth mentioning that is the first large-scale international clinical study of lung squamous cell carcinoma led by Chinese researchers (Professor Zhou Caicun , Shanghai Pulmonary Hospital).
This study enrolled 537 patients with advanced squamous cell carcinoma who had not received systemic treatment before, and received treatment plans of slulizumab combined with chemotherapy or placebo combined with chemotherapy respectively.
Results show:
In the currently published interim analysis data of the Asian population, the objective response rate of the slurizumab combined with chemotherapy group was as high as 75%, while the control group was only 55.5%. This means that 75% of tumors have significantly reduced by more than 30% in patients receiving a new combination therapy regimen.
In addition, the median progression-free survival time (PFS) was 9.79 months vs 5.72 months, and the median duration of remission (DoR) was 10.64 months vs 4.50 months. Slulizumab combined with chemotherapy has brought significant benefits to patients with pulmonary squamous cell carcinoma.
What is more worth mentioning is that the median progression-free survival time (PFS) of can reach 9.79 months. This is the longest PFS result seen in the Phase III study of the first-line treatment of lung squamous cell carcinoma , which is very exciting, which means that patients with lung squamous cell carcinoma have a new choice to obtain longer survival time.
About slulizumab
Slulizumab (H drug, serplulimab, HLX10) is an innovative PD-1 drug independently developed by China.
On March 24, 2022, it was approved for the first time in China for the first time for the treatment of single-drug treatment, unresectable, metastatic highly microsatellite unstable (MSI-H) solid tumor after failure of standard treatment. It is the seventh PD-1 monoclonal antibody approved for marketing in China. It is also the first domestic "pan-cancer" PD-1, fully opening a new era of unlimited cancer treatment in China.
In addition to the two major indications of lung squamous cell carcinoma and solid tumor , the trial of slulizumab in other multiple tumor types such as liver cancer , head and neck tumors, etc. is in full swing. A major good news for the majority of domestic patients is that clinical trials have been launched for this excellent drug. Patients who hope to try new drugs can contact the Medical Department of Global Oncology Doctors Network for details.
11 PD-1/L1 models worldwide have been approved, constantly refreshing the survival period for lung cancer
At present, there are many PD-1/L1 drugs approved at home and abroad. In addition to Slurimucin, which has just entered the front line, 11 PD-1/L1 models worldwide have been approved for non-small cell lung cancer.The Department of Medicine of Global Cancer Doctors Network has compiled the immunotherapy currently approved by the US FDA and China's NMPA for all lung cancer patients, and there are also many new immunotherapy methods under development for your reference.
In addition to the drugs approved above, there are more new drugs under development. The good news is that many new immunotherapies launched at home and abroad and under development are being recruited in China for clinical trials!
hope that immunotherapy can achieve a more brilliant record, and also hope that our domestic anti-cancer drugs can catch up with the United States as soon as possible, and more affordable anti-cancer drugs will benefit more patients.
Reference:
https://www.nmpa.gov.cn/