Lung cancer! Sanofi/Regenerative Dollar Libtayo single-drug first-line treatment PD-L1 high expression lung cancer stage III significantly prolongs survival, early termination!

April 27, 2020 /
prnewswire
BIOON/ -- Sanofi and partner Regeneron recently announced that a Phase III trial evaluating anti-PD-1 therapy Libtayo (cemiplimab) for the treatment of non-small cell lung cancer (NSCLC) has reached its primary end in total survival (OS) Under the recommendation of the Independent Data Monitoring Board (IDMC) to discontinue the trial as soon as possible, the trial will be modified to allow all patients to receive Libtayo treatment The data will serve as a basis for filing regulatory filings with the United States and the European Union in 2020 This is an open label, randomized, multicenter Phase III trial, which was conducted in patients who tested positive for PD-L1 in tumor cells, comparing the efficacy and safety of Libtayo monotherapy with platinum-containing double-acting chemotherapy for first-line therapy The trial included a total of 712 patients (710 cases included in the interim analysis), including patients who were not suitable for surgical excision or curative radiation chemotherapy or advanced after the treatment of chemotherapy( phase IIIB/C) NSCLC, and patients with previously untreated metastatic (phase IV) NSCLC The trial provides the most of big data that are currently available in critical trials in this patient population in the trial, patients were randomly grouped with 1:1, one group received an intravenous infusion of 350 mg of Libtayo every 3 weeks until 108 weeks, and the other group received a platinum-containing double-effect chemotherapy regimen selected by the researchers for 4-6 cycles (with or without pemerace to maintain chemotherapy) The primary endpoints are Total Lifetime (OS) and Progressless Lifetime (PFS), and secondary endpoints include Total Mitigation Rate (ORR), Mitigation Duration (DOR), and Quality of Life the trial is designed to reflect current and emerging treatment patterns The inclusion criteria allow NSCLC patients to have: controlled hepatitis B, hepatitis C, HIV, with pre-treatment and stable brain metastasis, and/or localized advanced diseases that have progressed in the treatment of chemotherapy Patients who progressed in the trial could change their treatment regimen: patients in the chemotherapy group could cross into the Libtayo group, while patients in the Libtayo group could combine Libtayo treatment with 4-6 cycles of chemotherapy mid-term analysis, specified by an agreement conducted by IDMC, showed a significant increase in OS in patients receiving Libtayo monotherapy Although up to one-third of patients have been tested in the last six months, and all chemotherapy patients can cross to Libtayo if their condition worsens, Libtayo significantly reduced the risk of death by 32.4% compared to platinum-containing double-effect chemotherapy (HR-0.676; CI: 0.525-0.870, p-0.002) No new safety signals were found in libtayo in the test Detailed trial data will be published at the upcoming medical conference , a separate Phase III trial is under way to evaluate Libtayo's first-line chemotherapy treatment for advanced NSCLC patients, regardless of PD-L1 expression levels The trial is expected to be completed in the patient group by 2020 Dr George D Yancopoulo, co-founder, president and chief scientific officer of Regeneration, said: "While proving that the survival benefits of first-line treatment of NSCLC have been challenging for immunotherapy, An anti-PD-1 monodotherapy approved by the FDA has changed treatment patterns We are pleased with the results of this trial, which demonstrates the survival benefits of Libtayo for these patients, and we hope that the drug will be a potential alternative for doctors and patients John Reed, M.D., head of global research and development at sanofi
, said: "This is an assessment of the largest-scale
clinical
trial spree for a PD-1 inhibitor as a first-line single-drug therapy for patients with advanced non-small cell lung cancer, which is highly expressive in patients with advanced non-small cell lung cancer, and these positive results are very encouraging, and we look forward to bringing a potential new treatment to these patients, and we thank all the researchers and patients involved in this global trial "
lung cancer is the leading cause of cancer death worldwide More than 2.2 million new cases are expected to be confirmed worldwide by 2020, with 228,800 new cases in the United States alone Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC), and an estimated 25% to 30% of cases are high expression of PD-L1 (PD-L1 positive in cells with a tumor of 50%) in the country) 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, a high-profile class of tumor immunotherapy designed to use the body's own immune system to fight cancer, and to kill cancer cells by blocking the PD-1/PD-L1 signaling pathway, with the potential to treat multiple types of tumor Libtayo is an all-human monoantigen that targets the immunocheckpoint receptor PD-1 on T cells By binding to PD-1, Libtayo has been shown to prevent cancer cells from inhibiting the activation of T cells through PD-1 in the United States, the European Union and other countries, Libtayo has been approved for treatment in adult patients who are not suitable for metastatic or localized advanced skin squamous cell carcinoma (CSCC) that are not suitable for curative surgery or curative radiotherapy Libtayo was created and optimized using the regenerative element patented Velocimmune technology platform, which is currently being jointly developed within the framework of the Global Cooperation Agreement between Regenerative Elements and Sanofi for the treatment of a wide range of cancers Libtayo's extensive clinical programs focus on cancers that are difficult to treat, including skin cancer, cervical cancer, solid tumors and blood cancers (biovalleybioon.com) original source: Phae 3 Trial of Libtayo ® (cemiplimab) a Monotherapy for Firt-Line Advanced-Mal Cell Lung Cancer Stopped Early Due To HighLy Highlight In 66 Survival