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Three PD-1 Anti-cancer drugs listed in Chinese Healthcare System! Much more Affordable!
Three PD-1 Anti-cancer drugs listed in Chinese Healthcare System!. As a representative of immunotherapy, PD-1/PD-L1 inhibitors can activate the body’s own immune system to attack tumor cells. It has the advantages of broad-spectrum, relatively long-lasting curative effect, and fewer side effects than traditional chemotherapy. It has been highly sought after since its inception.
Immunotherapy is particularly suitable for non-solid tumors. Currently, it has shown excellent efficacy in solid tumors such as lung cancer, urothelial cancer, and kidney cancer. However, most of the annual treatment costs of PD-1/PD-L1 inhibitors are still more than 100,000 yuan. Due to their high costs, some patients are “daunted” and eventually miss the best time to use immunotherapy.
In view of the current increasing demand for immunotherapy by cancer patients, immunotherapy can be said to be the “top priority” of this medical insurance negotiation. After more than three months of negotiations, the National Medical Insurance Bureau held a press conference on December 28 to officially announce the results of the 2020 National Medical Insurance Drug Catalogue negotiations! Let us take a look at which three immunization drugs officially “debut” this time and enter the ranks of medical insurance.
According to the published information, in this medical insurance negotiation, a total of 162 drugs were negotiated and 119 successfully negotiated, including 96 exclusive drugs. The negotiation success rate was 73.46%, an average decrease of over 50%! There are 14 kinds of anti-cancer drugs in the medical insurance catalog.
Among them, three domestic PD-1, including Hengrui Medicine’s carrelizumab, BeiGene’s tislelizumab, and Junshi Biologics’ teriprizumab, were successfully included in medical insurance through negotiations.
After Carrelizumab is successfully included in medical insurance negotiations, the price of the drug may drop by more than 80%, and each only costs about 3,000 yuan! The four approved indications for Karelizumab (Hodgkin’s lymphoma, non-squamous non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma) are all included in the medical insurance.
01. What is PD-1?
Before understanding PD-1, we first need to know what tumor immunotherapy is.
When the body’s own immune system is functioning normally, it will attack those substances that shouldn’t exist in the body (such as cancer cells) and avoid attacking normal cells. The task of tumor immunotherapy is to help the body’s own immune system recognize cancer cells and eventually kill them.
However, cancer cells are cunning. In the biological evolution process of survival of the fittest, they have developed a strategy to avoid the “chase” of the immune system-producing a protein called PD-L1 on the cell surface.
PD-L1 binds to the PD-1 receptor on the T cell membrane to’turn off’ the T cell, which causes the immune system to paralyze. Of the two currently approved lung cancer immunotherapy drugs in the United States, one acts on PD-L1 and the other acts on PD-1 receptors, preventing cancer cells by inhibiting or blocking the binding of PD-L1 to PD-1 receptors ‘Turn off’ the T cell. After the treatment, the T cells are activated again to restore the functioning of the immune system, thus being able to fight cancer again. In addition, there are other kinds of drugs in clinical trials of lung cancer immunotherapy, which can achieve the purpose of treatment through other ways.
Mechanism of action of PD-1 drugs
Nowadays, related PD-1 drugs have been used clinically, and they have performed gratifyingly in the treatment of cancer. They can even significantly extend the lives of patients and reduce their pain in many advanced or even terminal cancers where traditional therapies have limited effects. pain.
02. PD-1 drugs that were successfully negotiated
As an innovative drug originally developed by some countries, carrelizumab has attracted industry attention since its inception, and has repeatedly appeared on the international stage and has been widely recognized in the oncology field at home and abroad. Four major indications have been approved:
Treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma who have undergone at least second-line chemotherapy;
Treatment of advanced hepatocellular carcinoma patients who have previously received sorafenib treatment and/or oxaliplatin-containing chemotherapy;
The combination of pemetrexed and carboplatin is suitable for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, non-resectable locally advanced or metastatic non-squamous non-small cell lung cancer ( NSCLC) first-line treatment;
Previously received treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma who had disease progression or intolerability after first-line chemotherapy.
The approval of carrelizumab for lung cancer indications is based on the CameL study-carrelizumab combined with carboplatin + pemetrexed for the first-line treatment of advanced/metastatic EGFR-/ALK-non-squamous non-small cell lung cancer The randomized, open, multi-center phase III clinical pivotal study.
The results of the study show that the combination of carrelizumab and pemetrexed/carboplatin has a strong curative effect. The ORR of the carrelizumab group was 60.0%, which was significantly higher than 39.1% of the chemotherapy group (p<0.0001); in terms of PFS, the median PFS of the carrelizumab group was 11.3 months, which was also higher than that of chemotherapy 8.3 months of the group (HR, 0.61[0.46‒0.80], p=0.0002).
Biozeran is the second independently developed drug approved by BeiGene and the first independently developed anti-cancer drug approved for marketing in China. The approved indications of tislelizumab are:
Treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line chemotherapy;
The failure of platinum-containing chemotherapy with high PD-L1 expression includes the treatment of locally advanced or metastatic urothelial cancer that has progressed within 12 months of neoadjuvant or adjuvant chemotherapy.
In addition to the above-mentioned declared or approved indications, the drug’s ongoing Phase 3 clinical studies for cancer types include: hepatocellular carcinoma, extensive-stage small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, nasopharyngeal carcinoma, etc. . Therefore, the fifth listing application for tislelizumab injection was submitted at CDE, and the indication may be one of the above five cancers that have advanced to the late clinical stage.
Previous studies have shown that in the treatment of patients with relapsed/refractory classic Hodgkin’s lymphoma with tislelizumab, patients who achieve CR are expected to have a longer duration of remission than those who achieve partial remission (PR). And progression-free survival time, suggesting that deeper remission may bring better long-term prognosis and survival benefits for patients with relapsed/refractory classic Hodgkin’s lymphoma.
Studies have shown that 61 patients (87.1%) achieved objective remission, and the vast majority of patients achieved remission at the first evaluation of efficacy (Figure 1). Among 61 patients who achieved objective remission, the median DOR and median PFS have not yet been achieved. It is worth noting that the depth of remission of tislelizumab treatment, most patients in remission achieved complete remission (44 cases, 62.9%).
PFS curve of patients with complete remission and partial remission after receiving tislelizumab
Teriplizumab is the first domestically-produced PD-1 inhibitor independently developed and approved for marketing in China. Based on its good efficacy and safety, the drug was approved by the National Medical Products Administration (NMPA) on December 17, 2018. ) Approved for marketing for the treatment of locally advanced or metastatic melanoma that has previously failed standard treatment.
In addition, clinical trials of teriprizumab in various solid tumors such as nasopharyngeal carcinoma (NPC), urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) have also been carried out and achieved gratifying results.
In a multi-evaluation center, open, one-arm, phase II of the effectiveness and safety of terreplimumab combined with chemotherapy in patients with advanced or recurring non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI treatment failure In the study, patients received teriprizumab combined with pemetrexed/carboplatin for 4 or 6 cycles (once every 3 weeks), and then received maintenance therapy with teriprizumab combined with pemetrexed until There is disease progression or no clinical benefit.
The results of the study showed that the overall ORR was 50.0%, the DCR was 87.5%, 20 cases of partial remission (PR) and 15 cases of stable disease (SD) (including 1 case of unconfirmed PR), and median duration of remission (DOR) reached 7.0 Month, median PFS was 7.0 months (95%CI, 4.8 months to 10.3 months).
For patients with advanced or relapsed NSCLC with EGFR-sensitive mutations who have failed EGFR-TKI treatment, the application of teriprizumab combined with carboplatin and pemetrexed has good anti-tumor efficacy and controllable safety. This treatment plan is expected Become a new standard treatment option for NSCLC patients after EGFR mutation-positive and EGFR-TKI treatment fails.
03. PD-1 drug market battle will continue
Speaking of domestic drugs, many people’s first impression is still in chemical generics, but in fact, in the higher-end biological drug field, local companies have already achieved corner overtaking.
Nowadays, the domestic PD-1 has begun to enter the era of rivalry. According to incomplete statistics, there are more than 20 domestic companies participating in the research and development of PD-1, which are in different clinical stages. It is expected that more PD-1 monoclonal antibodies will be born in the next two or three years.
During the medical insurance negotiations, foreign capital was wiped out, and domestically-made innovative drugs came to the fore. It is foreseeable that the domestic PD-(L)1 market competition will become fiercer next year, and domestic and imported varieties may also take completely different paths. , Many parties will fight in the medical insurance market and the self-pay market.
(source:chinanet, reference only)