Globally, lung cancer can be said to be the "number one killer" that threatens human health. In China, lung cancer ranks first in incidence and mortality of all malignant tumors. According to the latest global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC), there will be about 820,000 new lung cancer cases in China in 2020, about 710,000 lung cancer patients will die, and almost every minute a lung cancer patient will be diagnosed. The reason for this situation is the harsh environmental factors of the past few decades and the low rate of early detection of lung cancer in China.
Thankfully, with the development of molecular biology in recent years, new drugs and new treatment models have emerged. Immunotherapy has been in the "C" position in lung cancer treatment. Domestic original research new drugs are also emerging in an endless stream, following the carellizumab, sindilimab, tripril monoclonal antibody and tirelizumab, the fifth domestic original research PD1 inhibitor came, the name is paiamprizumab.
Pisaprizumab is a new IgG1 subtype PD-1 monoclonal antibody, and its advantages are reflected in the following three points:
1. The new PD-1 monoclonal antibody with Fc segment modification of IgG1 subtype has better stability and can effectively avoid the problem of traditional PD-1 monoclonal antibody IgG4 intergamerization and inhibition of humoral immunity.
2. The Fc effect is completely eliminated by Fc segment modification (the Fc segment and other IgG FCs aggregate themselves to form dimers, reducing the binding to PD-1).
3.Fc segment modification inhibits macrophage secretion of IL-6, thereby reducing the occurrence of immune-related inflammation and enhancing the safety of the drug.
In fact, on August 5, 2021, paemprizumab injection was approved for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have at least undergone second-line systemic chemotherapy.
So, how effective is paemprizumab on lung cancer?
In the randomized, double-blind, multicenter Phase III clinical study (AK105-302), 350 patients diagnosed with locally advanced or metastatic squamous cell carcinoma who had not previously received systemic therapy were randomized to trial and control groups on a 1:1 basis. The trial group received paemprilliumab plus paclitaxel + carboplatin for 4 cycles, followed by maintenance therapy with pisapramineab until disease progression occurred, intolerable toxicity developed, or the researchers judged that the subjects could not continue to benefit. The control group received placebo + paclitaxel + carboplatin, and the control group subjects were allowed to cross-receive open-ended piambrylizumab monotherapy after disease progression for up to 24 months.
The results showed that patients with metastatic squamous cell carcinoma who received paenoprulimab plus chemotherapy had a median progression-free survival (mPFS) of 7.0 months, which was significantly better than the 4.2 months in the placebo group. The objective response rate (ORR) in the paganprizumab treatment group was 69.7%, which was also significantly higher than the 43.4% in the placebo group. The median duration of remission (mDoR) was 9.4 months, significantly longer than the 3.0 months in the placebo group. In terms of adverse reactions, the incidence of adverse events of the second and higher grades 3 is similar.
Based on the above research, a few months ago, the State Food and Drug Administration has accepted the application for a new indication for the treatment of locally advanced or metastatic squamous non-small cell lung cancer in the first line of paamprizumab combined with chemotherapy, and it is estimated that it will soon be approved as an indication for lung squamous cell carcinoma.