Keytruda's new appevertic crash Libtayo PD-1/L1 competition is intensifying.

, Keytruda (pembrolizumab) was approved by the FDA for extended indications for the treatment of patients with recurrent/metastatic skin squamous cell carcinoma (CSCC) who cannot be cured by surgery or radiotherapyThis approval, or will directly threaten Sanofi/Regenerative Dollar Libtayo (cemiplimab-rwlc) in the field of skin cancerCSCC is one of the most common skin cancers in the world and can be cured at an early stage by root surgery or radiotherapy, but clinical treatment options are limited when CSCC invades deep skin or adjacent tissues (local late-stage CSCC) or spreads to other distant parts of the body (metastatic CSCC)According to historical data, the life expectancy of patients with advanced CSCC (including patients with local advanced and metastatic CSCC) is about one year, and new and effective treatments are urgently neededLibtayo is also an all-human monoclonal antibody for immune checkpoint receptor PD-1 (procedural cell death protein-1), approved by the FDA in September 2018 for the treatment of local late-stage CSCC and metastatic CSCC adult patients not suitable for root surgery or therapeutic radiotherapy, making it the first drug in the U.Smarket to receive regulatory approval for advanced CSCC treatmentIn July 2019, the indication was accelerated in the European UnionLibtayo's sales in the first quarter of this year were 12 million euros, according to Sanofi's Q1 2020 report, in addition to CSCC, Libtayo has been developed to treat other cancers, such as non-small cell lung cancer (NSCLC), cervical cancer, head and neck cancer, prostate cancer, melanoma, B-cell lymphoma, etc., with clinical trials for cervical cancer and NSCLC progressing to Phase IIIApril this year, Libtayo achieved the primary endpoint of the Total Survival (OS) in an open-label, randomized, multicenter Phase III trial in patients with advanced NSCLC patients who tested positive for PD-L1 in 50% of tumor cellsThe study, which aims to compare the efficacy and safety of Libtayo monodrug therapy with platinum-containing bipharmaceutical chemotherapy for first-line therapy, was described in an interim analysis by an agreement conducted by the Independent Data Monitoring Board to show that Libtayo reduced the risk of death by 32.4 per cent compared to chemotherapy with platinum-containing bipharmaceuticalsthe approval of Keytruda CSCC Indications is based on a multi-center, multi-queue, non-randomized, open PHASE II trial, KEYNOTE-629 (NCT03284424)The data showed that Keytruda showed meaningful efficacy and lasting remission, with an objective mitigation rate (ORR) of 34% (95% CI:25-44), a full mitigation rate (CR) of 4%, and a partial mitigation rate (PR) of 31%In patients with remission, 69% of patients with remission lasted 6 months or moreAfter 9.5 months of median follow-up, the median mitigation duration (DOR) still did not reach (2.7-13.1 months)In terms of safety, adverse reactions in CSCC patients were similar to those in Keytruda single drug treatment for melanoma or non-small cell lung cancer, and the common adverse event of 3-4 is lymphocyte reductionBefore , Keytruda has been approved by the FDA for more than 20 indications, including NSCLC, SCLC, kidney cell carcinoma, head and neck squamous cell carcinoma, urinary tract cancer (UC), bladder cancer, stomach cancer or gastroesophageal cancer, Hodgkin lymphoma (HL), cervical cancer, liver cancer, etc and two non-cancer-resistant types of indications -- microsatellite instability (MSI-H) / mismatch repair defect (dMMR) solid tumors and non-removable or metastatic solid tumors with a high tissue tumor mutation load (TMB-H) of 10 mutations/Mb (using FDA-specified tests) in addition, Keytruda has recently been approved by the FDA for single-drug first-line treatment for patients with non-removable or metastatic microsatellite instability (MSI-H) or mismatch edimen (dMMR) colorectal cancer This is the first-ever first-line immunotherapy approved by Keytruda based on MSI-H or dMMR biomarkers, and another breakthrough in the screening of patients with molecular biology markers from the above information can be seen, Libtayo and Keytruda have been in the CSCC indications crash, as to the efficacy of who is better, due to no head-to-head test, it is not yet possible to judge, but the author estimates that Keytruda's approval will more or less affect Libtayo's position in the field of skin cancer, and according to the development of Libtayo adaptation, it is expected that the two drugs will soon be in THE UC, NSCLC crash PD-1/L1 inhibitors are a hot type of immunotherapy developed in recent years, so far, according to the insight database globally has approved 10 PD-1/L1 monotonica, see the table below, of which only the doflizumab, atilizumab and Aviru monotonica target simply PD-L1 of these 10 drugs, Keytruda has performed well, with the most approved indications, the highest global sales, and the $10 billion mark for the first time in 2019 The second, third and fourth-ranked sales were Opivo, Tecentriq and Imfinzi, with sales of $8.005 billion, $1.886 billion and $1,469 million in 2019, respectively Libtayo and Bavencio's 2019 sales were not as good as they could have been, although Libtayo reported sales of 12 million euros in the first quarter of 2020 and Bavencio's global sales for 2018 were 69 million euros, and Bavencio's sales in 2019 were higher than Libtayo's The remaining four domestic PD-1 single resistance, because only approved in China, sales can not be compared with the above four imported PD-1/L1 single resistance, but Daberschu, Tuyi 2019 sales are 1.0159 billion yuan, 774.1 million yuan, Erica 2019 specific sales were not announced, the industry estimated to exceed 1 billion yuan, Baize An in the late sales of 2019 as can be seen from the above table, 10 PD-1/L1 monoabs have been approved for intersecting in the field of indications, particularly in the field of lung cancer And the above-mentioned drugs are still developing new indications, presumably in the future with the approval of the new PD-1/L1 monoantiphoresis and the approval of PD-1/L1 monoantithed new indications, the global PD-1/L1 market is bound to have a fierce killing.