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Libtayo: First immunotherapy significantly improve survival of Cervical cancer
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Libtayo: First immunotherapy significantly improve survival of Cervical cancer.
Cervical cancer immunotherapy! Sanofi/Regeneron anti-PD-L1 therapy Libtayo: the first immunotherapy that can significantly improve survival (OS)!
Sanofi and its partner Regeneron recently announced the positive results of a phase 3 clinical trial of anti-PD-1 therapy Libtayo (cemiplimab) for the treatment of cervical cancer at the ESMO Virtual Plenary of the European Society for Medical Oncology (ESMO Virtual Plenary) .
The trial is in patients with recurrent or metastatic cervical cancer who have previously received chemotherapy, regardless of the PD-L1 expression status.
The results announced at this meeting supplemented the previously reported data, showing that compared with chemotherapy, Libtayo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
In addition, Libtayo is superior to chemotherapy in terms of patient-reported results (PRO), and there are significant differences.
These data will become the basis for submitting a regulatory application in 2021.
It is worth mentioning that Libtayo is the first immunotherapy shown to significantly improve OS, PFS, and ORR in cervical cancer patients: Compared with chemotherapy, it reduces the risk of death by 31% (HR=0.69, unilateral p=0.00011 ), reduce the risk of disease progression by 25% (HR=0.75, unilateral p=0.00048), and significantly increase ORR (16% vs 6%; unilateral p=0.00004).
Up to now, Libtayo has obtained positive key data in 4 cancer types. Prior to this, Libtayo also obtained the first key results of its kind in the treatment of advanced basal cell carcinoma (BBC) and advanced skin squamous cell (CSCC).
Recurrent or metastatic cervical cancer is notoriously difficult to treat, and there is no approved standard care regimen after first-line chemotherapy.
In this trial, patients enrolled regardless of their tumor PD-L1 status. The results confirmed that Libtayo has a significant effect compared with chemotherapy.
Krishnansu S. Tewari, an investigator of the trial and professor and director of the Department of Gynecological Oncology at the University of California, said: “In this phase 3 clinical trial, patients with recurrent or metastatic cervical cancer who have previously received platinum-containing chemotherapy are treated in the entire study population Compared with chemotherapy, Libtayo reduced the risk of death by 31%.
In addition, in the entire study population, Libtayo also showed significant improvements in PFS and ORR compared with chemotherapy.
This milestone clinical achievement supports Libtayo is used as a new second-line treatment for female patients with advanced cervical cancer who have a poor prognosis and limited treatment options.”
The announcement this time is an open-label, randomized, multi-center, phase 3 clinical trial, which will be carried out in patients with recurrent or metastatic cervical cancer who have progressed after receiving platinum-containing chemotherapy, combining Libtayo monotherapy with the chemotherapy selected by the investigator The schemes were compared.
Regardless of the PD-L1 expression in the tumor, 78% of the patients were squamous cell carcinoma, and 22% of the patients were adenocarcinoma.
This is the largest phase 3 randomized clinical trial in the treatment of advanced cervical cancer, enrolling female patients in 14 countries around the world (median age: 51 years).
These patients were randomly assigned to the Libtayo monotherapy group (350 mg once every 3 weeks) or the usual chemotherapy regimen group selected by the investigator (pemetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine). Compared with the chemotherapy group, patients in the Libtayo treatment group experienced:
—In the entire study group:
(1) The risk of death was reduced by 31%. The median survival time of the Libtayo treatment group (n=304) was 12.0 months, and the chemotherapy group (n=305) was 8.5 months. The data are statistically available There was a significant difference in school (HR=0.69; 95%CI: 0.56-0.84; one-sided p=0.00011).
(2) The risk of disease progression is reduced by 25% (HR=0.75; 95%CI: 0.63-0.89; unilateral p=0.00048).
(3) ORR was significantly improved (16% vs 6%; p=0.00004), and the median duration of response (DOR) was significantly extended (16 months vs 7 months).
—In the squamous cell carcinoma population:
(1) The risk of death was reduced by 27%, the median survival time of the Libtayo treatment group (n=239) was 11.1 months, and the chemotherapy group (n=238) was 8.8 months. The data have Statistically significant difference (HR=0.73; 95%CI: 0.58-0.91; one-sided p=0.00306).
(2) The risk of disease progression was reduced by 29% (HR=0.71; 95%CI: 0.58-0.86; unilateral p=0.00026).
(3) ORR increased (18% vs 7%).
—In the adenocarcinoma group:
(1) The risk of death was reduced by 44%, the median survival time of the Libtayo treatment group (n=65) was 13.3 months, and the chemotherapy group (n=66) was 7.0 months. The data are statistically significant Significant difference (HR=0.56; 95%CI: 0.36-0.85; nominal one-sided p<0.005).
(2) The risk of disease progression is reduced by 9% (HR=0.91; 95%CI: 0.62-1.34).
(3) ORR increased (12% vs 5%).
—Health Status/Quality of Life:
Patients treated with Libtayo were able to improve or maintain their baseline overall health status/quality of life (GHS/QOL) over time, while those who received chemotherapy experienced the Clinically significant deterioration starting from 8 cycles, according to EORTC QLQ-C30 (overall estimated average change 95% CI: Libtayo improved 1.01[-2.033,4.047], chemotherapy worsened -6.81[-10.977,-2.637];difference=7.81; One-sided nominal p=0.00040).
—In this test, no new safety signal of Libtayo was observed.
Adverse events occurred in 88% of patients in the Libtayo treatment group, 91% in the chemotherapy group, and serious adverse events in 30% and 27% of patients, respectively.
Cervical cancer is the fourth leading cause of cancer deaths in women worldwide, and women aged 35-44 are most commonly diagnosed with cervical cancer.
Almost all cases are caused by human papillomavirus (HPV) infection. About 80% are classified as squamous cell carcinoma (cells originating in the bottom of the cervix), and most of the remaining are adenocarcinoma (originating in the upper part of the cervix). Glandular cells).
Cervical cancer is usually curable when it is detected and effectively treated at an early stage, but the treatment options for late stage are more limited.
It is estimated that about 570,000 women worldwide are diagnosed with cervical cancer each year. In the United States, 14,500 new cases are diagnosed each year, and about 4,000 deaths each year.
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.
Previously, Libtayo has been approved for the treatment of two most common 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 non- It is suitable for patients with locally advanced CSCC who have undergone radical surgery or radical radiotherapy;
(2) Libtayo is the first immunotherapy approved for the treatment of advanced basal cell carcinoma (BCC), which is suitable for the treatment of a previously accepted hedgehog pathway inhibition Patients with advanced BCC who are treated with HHI or are not suitable for treatment with such drugs.
In February 2021, Libtayo was approved by the US FDA for the third indication: for the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with tumors with high PD-L1 expression (tumor ratio score [TPS] ≥50%), specifically : NSCLC patients with tumors with high PD-L1 expression (TPS≥50%), metastatic or locally advanced tumors, unsuitable for surgical resection or radical radiotherapy and chemotherapy, and tumors without EGFR, ALK or ROS1 aberrations.
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 refractory cancers, including skin cancer, cervical cancer, solid tumors and blood cancers.
Libtayo: First immunotherapy significantly improve survival of Cervical cancer.
(source:internet, reference only)