At the 2022 Chinese Society of Clinical Oncology (CSCO) Guidelines Conference, the domestic original research immunodrug Piamprizumab combined with chemotherapy was listed as a recommended regimen in the new CSCO guidelines for the treatment of advanced pulmonary squamous cells first-line cancer treatment.
Piamprimab is a novel programmed cell death protein-1 (PD-1) monoclonal antibody drug. It is currently the only drug using immunoglobulin G1. (IgG1) subtype and Fc segment modified new PD-1 monoclonal antibody. The advantage of this antibody upgrade is that it can reduce the immune response during drug use, increase drug safety, and reduce adverse reactions.
Actually, on August 5, 2021, Pembrolizumab was approved by the National Medical Products Administration (NMPA) of China for the treatment of patients who have undergone at least second-line systemic chemotherapy for relapse or Adult patients with refractory classical Hodgkin lymphoma (r/r cHL).
In terms of lung cancer, the phase III clinical study (AK105-302 study) of Piamprimab combined with chemotherapy in the first-line treatment of metastatic squamous NSCLC led by Professor Han Baohui was announced at this year’s CSCO conference The latest data show its surprising efficacy. The results of the study showed that compared with the chemotherapy group, Pienpilimumab combined with chemotherapy significantly improved the progression-free survival (PFS, 7 months vs 4.2 months) and objective response rate (ORR, 69.7% vs 26.3) of squamous NSCLC %), and the safety is good. With the recommendation of the 2022 version of the CSCO Lung Cancer Guidelines, the approval of the first-line indications of Piamprimab for squamous cell carcinoma of the lung should not be far off.
Today, let’s take a look at the domestic PD-1/PD-L1 inhibitors that have been approved by the Food and Drug Administration for the treatment of lung squamous cell carcinoma
1. Tislelizumab
On January 13, 2021, tislelizumab (Bai Zean) was approved for the treatment of lung squamous cell carcinoma. The specific indications are: combined with paclitaxel and carboplatin for locally advanced or first-line treatment of metastatic squamous non-small cell lung cancer. Tislelizumab became the first domestic PD-1 inhibitor approved for first-line treatment of advanced squamous cell carcinoma of the lung. The approval is based on the Phase III RATIONALE 307 study. The results showed that tislelizumab combined with chemotherapy significantly prolonged PFS (median PFS: 7.6 vs 5.5 months), and tislelizumab combined with paclitaxel and carboplatin reduced the risk of disease progression or death by 48%.
2. Sintilimab
On June 3, 2021, the State Drug Administration approved a new indication of sintilimab (Dabosu), which is the first-line treatment of advanced squamous cell carcinoma in combination with chemotherapy drugs , the specific indications are: combination chemotherapy drugs gemcitabine and carboplatin, first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer adult patients. Based on the phase III ORIENT-12 trial, the study results showed that the median PFS assessed by the independent imaging committee was 5.5 months in the sintilimab combination arm and 4.9 months in the chemotherapy arm, and the median PFS assessed by the investigator was 5.5 months and 4.9 months, respectively. At 6.7 months and 4.9 months, the median OS data is not yet mature, and the sintilimab combination group has a trend of benefiting overall survival compared with the chemotherapy group.
3. Camrelizumab
On December 10, 2021, camrelizumab (Erica) was approved for first-line treatment of squamous cell carcinoma of the lung. Specifically: combined paclitaxel and carboplatin for the first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer. This indication is based on the phase III CameL-sq study, which showed that the median progression-free survival (PFS) of camrelizumab combined with carboplatin and paclitaxel in the first-line treatment of advanced squamous non-small cell lung cancer reached 8.5 months, and the treatment had an objective response. The rate ORR was 64.8%.
Because the first-line indication of camrelizumab for the treatment of advanced squamous cell carcinoma was approved too late, in the new medical insurance catalogue in January 2022, the indication for squamous cell carcinoma of the lung is still not available. to reimburse.
4. Sugelimumab
On December 21, 2021, the State Food and Drug Administration approved the launch of a new domestic drug, sugelimab (Zejiemei). The biggest highlight is the simultaneous approval of first-line treatment of squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. The indications for squamous cell carcinoma of the lung are: first-line treatment of patients with metastatic squamous non-small cell lung cancer in combination with paclitaxel and carboplatin. Based on the multicenter, randomized, double-blind GEMSTONE-302 study, sugelimab combined with chemotherapy has obvious advantages in the diagnosis and treatment of lung squamous cell carcinoma. The risk of death is 66%.