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Sanofi/Regeneron anti-PD-1 therapy Libtayo: Treating lung cancer
Sanofi/Regeneron anti-PD-1 therapy Libtayo: Treating lung cancer. First-line immunotherapy for lung cancer! Sanofi/Regeneron anti-PD-1 therapy Libtayo: Treating lung cancer with high PD-L1 expression significantly prolongs overall survival!
Sanofi and its partner Regeneron recently announced that the key phase 3 EMPOWER-Lung 1 study results of the comparative anti-PD-1 therapy Libtayo (cemiplimab) in the treatment of non-small cell lung cancer (NSCLC) have been published internationally The medical journal “The Lancet” (The Lancet).
The study was carried out in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with ≥50% tumor cells expressing PD-L1. The data showed that compared with platinum-containing dual-effect chemotherapy, Libtayo first-line treatment significantly prolonged overall survival (OS). Although a very high proportion of patients in the chemotherapy group (with a crossover rate of 72%) switched to the Libtayo group after the disease progressed, Libtayo is still superior to chemotherapy in prolonging OS.
The data from the EMPOWER-Lung 1 trial is the basis of the regulatory application documents for Libtayo’s first-line treatment of PD-L1 high expression (≥50%) advanced NSCLC. Currently, the application for this indication is being reviewed by the US FDA and the EU EMA. In the United States, the target date of the “Prescription Drug User Charges Act” is February 28, 2021; in the European Union, the review results are expected to be obtained in the second quarter of 2021.
Dr. Ahmet Sezer, an investigator of the EMPOWER-Lung 1 trial and a professor of medical oncology at Adanabakan University in Turkey, said: “These clinical results published in The Lancet support Libtayo as a late stage with PD-L1 expression of ≥50%. Regulatory opinions on potential new treatment options for patients with non-small cell lung cancer.
Compared with chemotherapy, Libtayo is superior in prolonging overall survival, even though 74% of patients are converted to the Libtayo group after chemotherapy progresses. In this key trial, Libtayo reduced the risk of death by 32% in the entire study population, and Libtayo reduced the risk of death by 43% in patients with a positive PD-L1 expression rate of ≥50%.
In addition, the data also includes the more advanced patient population that is usually underrepresented in advanced non-small cell lung cancer trials, including 12% of patients who have previously received a large number of regimens (pretreated) and stable brain metastases, and 16% are not suitable for radiotherapy and chemotherapy. Patients with advanced non-small cell lung cancer. Therefore, the medical community now has very valuable new clinical evidence that can enhance our understanding of how to treat this deadly cancer. “
EMPOWER-Lung 1 is an open-label, randomized, multi-center phase III trial that was carried out in patients with squamous or non-squamous advanced NSCLC with positive PD-L1 expression in ≥50% of tumor cells. It compared the Libtayo single The efficacy and safety of drug therapy and platinum-containing dual-effect chemotherapy for first-line treatment. The trial enrolled 712 patients (710 were included in the interim analysis), including patients with locally advanced (IIIB/C) NSCLC who were not suitable for surgical resection or radical radiotherapy or chemotherapy or who had progressed after radical radiotherapy and chemotherapy, as well as previous Patients with untreated metastatic (stage IV) NSCLC.
The trial aims to reflect current and emerging treatment models. The inclusion criteria allow NSCLC patients to have: controlled hepatitis B, hepatitis C, HIV, with pre-treatment and stable brain metastasis, and/or receive radical radiotherapy and chemotherapy for locally advanced disease that has progressed. Patients who have progressed in the trial can change their treatment plan: patients in the chemotherapy group can cross into the Libtayo group, and patients in the Libtayo group can combine Libtayo treatment with 4-6 cycles of chemotherapy.
In April 2020, an agreement-designated interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed a significant increase in overall survival (OS) in patients receiving Libtayo monotherapy. Although as many as one-third of patients entered the trial within the past six months, and all chemotherapy patients could cross over to Libtayo treatment if their condition worsened, compared with platinum-containing dual-effect chemotherapy, Libtayo significantly reduced the risk of death by 32.4 %(HR=0.676; CI: 0.525-0.870, p=0.002). No new safety signals for Libtayo were found in the test.
The detailed data of the trial will be announced at the ESMO meeting in September 2020. The results show that:
——In the entire patient population (n=710):
(1) Compared with chemotherapy, Libtayo reduced the risk of death by 32% (HR=0.68; p=0.0022) and prolonged the overall survival (median OS: 22 months vs 14 months);
(2) Compared with chemotherapy, Libtayo reduced the risk of disease progression or death by 41% (HR=0.51; p<0.0001) and prolonged progression-free survival (median PFS: 6.2 months vs 5.6 months);
(3) Compared with chemotherapy, Libtayo improves the objective response rate (ORR: 37% vs 21%).
——In the patient population with PD-L1 expression ≥50% (n=563):
(1) Compared with chemotherapy, Libtayo reduced the risk of death by 43% (HR=0.57; p=0.0002) and prolonged the overall survival (median OS: not reached vs 14 months);
(2) Compared with chemotherapy, Libtayo reduced the risk of disease progression or death by 46% (HR=0.54; p<0.0001) and prolonged progression-free survival (median PFS: 8 months vs 6 months);
(3) Compared with chemotherapy, Libtayo improves the objective response rate (ORR: 39% vs 20%).
——The test also found that the tumor response in patients treated with Libtayo is directly related to PD-L1 expression.
Among tumors with PD-L1 expression ≥90%, ORR was the highest (46%; range: 36-56%), and the target tumor shrank by more than 40% on average after 6 months of treatment (based on the last observation). This correlation with PD-L1 expression level was not observed during chemotherapy.
Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that by 2020, more than 2.2 million new cases will be diagnosed globally, and there will be 228,800 new cases in the United States alone. Approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), and it is estimated that 25% to 30% of cases have high PD-L1 expression (PD-L1 positive is detected in ≥50% of tumor cells). In recent years, although immunotherapy has changed the treatment of patients with advanced NSCLC, there is still a need to optimize the identification and treatment of patients with high PD-L1 expression.
Libtayo is an anti-PD-(L)1 inhibitor, which is currently a high-profile tumor immunotherapy, which aims to use the body’s own immune system to fight cancer and block the PD-1/PD-L1 signaling pathway to make cancer Cell death has the potential to treat many types of tumors. Libtayo is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to prevent cancer cells from inhibiting T cell activation through the PD-1 pathway.
Currently, Libtayo has been approved for the treatment of the two most common types of advanced skin cancer patients:
(1) Libtayo is the first drug approved for the treatment of advanced skin squamous cells (CSCC), suitable for the treatment of patients with metastatic CSCC and locally advanced CSCC patients who are not suitable for radical surgery or radical radiotherapy;
(2) Libtayo is the first immunotherapy approved for the treatment of advanced basal cell carcinoma (BCC). The drug is suitable for the treatment of advanced stages that have previously received a hedgehog pathway inhibitor (HHI) treatment or are not suitable for this type of drug treatment BCC patients.
Libtayo uses Regeneron’s patented Velocimmune technology platform to create and optimize it. It is currently under joint development under the framework of a global cooperation agreement between Regeneron and Sanofi for the treatment of various types of cancer. Libtayo’s extensive clinical projects focus on intractable cancers, including skin cancer, cervical cancer, solid tumors and blood cancers.
(source:internet, reference only)