Sanofi/Regeneron's Libtayo Achieves Positive Phase 3 Results in Cervical Cancer: First Immunotherapy to Significantly Improve Overall Survival

March 15, 2021 /Bio ValleyBIOON/ -- Sanofi and its partner Regeneron recently jointly announced the Phase 3 trial of the anti-PD-1 therapy Libtayo (cemiplimab) for the treatment of cervical cancerClinical Trialpositive results. The trial was conducted in patients with recurrent or metastatic cervical cancer who had previously received chemotherapy, regardless of PD-L1 expression status. The results showed that Libtayo significantly improved overall survival (OS) compared with chemotherapy. Based on the unanimous recommendation of the Independent Data Monitoring Committee (IDMC), the trial will be stopped early, and these data will form the basis for regulatory submissions in 2021.

It is worth mentioning that,Libtayo is the first immunotherapy shown to significantly improve overall survival (OS) in patients with cervical cancer, reducing the risk of death by 31% compared with chemotherapy.。To date, Libtayo has achieved positive pivotal data in four cancer types. Previously, Libtayo also secured the first-in-class pivotal results in the treatment of advanced basal cell carcinoma (BCC) and advanced cutaneous squamous cell carcinoma (CSCC).

Investigators of the trial, University of California GynecologyTumorProfessor and Department Chair Krishnansu S. Tewari stated, “Libtayo monotherapy is the first drug to demonstrate an improvement in overall survival in a Phase 3 trial involving patients with recurrent or metastatic cervical cancer who had previously received platinum-based chemotherapy. This milestone clinical achievement brings hope to patients with advanced cervical cancer, who are younger than those with other types of cancer, as reflected by the median age of only 51 years in this trial.”

Dr. Israel Lowy, Senior Vice President of Oncology Translational and Clinical Sciences at Regeneron, stated: “Recurrent or metastatic cervical cancer is notoriously difficult to treat, and there are no approved standard-of-care regimens after first-line chemotherapy. In this trial, regardless of patient”Tumor“Regardless of PD-L1 status, all patients were enrolled in the trial. The results confirmed that Libtayo monotherapy can help patients with recurrent or metastatic cervical cancer who have progressed after prior chemotherapy to survive longer. This is the fourth patient population in which Libtayo has demonstrated clinical benefit, and we look forward to submitting the results to regulatory authorities later this year.”

This announcement pertains to an open-label, randomized, multicenter, Phase 3Clinical Trials, conducted in patients with recurrent or metastatic cervical cancer whose disease progressed after platinum-based chemotherapy, comparing Libtayo monotherapy with investigator’s choice of chemotherapy. Regardless of patientTumorPatients were eligible for enrollment regardless of PD-L1 expression status; 78% had squamous cell carcinoma, and 22% had adenocarcinoma.

This is the largest Phase 3 randomized trial conducted in the treatment of advanced cervical cancer.Clinical Trial, a total of female patients from 14 countries worldwide were enrolled (median age: 51 years). These patients were randomized to receive either Libtayo monotherapy (350 mg every 3 weeks) or investigator’s choice of standard chemotherapy regimens (pemetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine). Compared with the chemotherapy group, patients in the Libtayo group experienced:

—In the overall study population, the risk of death was reduced by 31%.The median overall survival was 12.0 months in the Libtayo treatment group (n=304) and 8.5 months in the chemotherapy group (n=305), with a statistically significant difference (HR=0.69; 95% CI: 0.56-0.84; p<0.001).

—In the squamous cell carcinoma population, the risk of death was reduced by 27%.The median overall survival was 11.1 months in the Libtayo treatment group (n=239) and 8.8 months in the chemotherapy group (n=238), with a statistically significant difference (HR=0.73; 95% CI: 0.58–0.91; p=0.003).

——A 44% reduction in the risk of death was observed in the adenocarcinoma population.The median overall survival was 13.3 months in the Libtayo treatment group (n=65) and 7.0 months in the chemotherapy group (n=66), with a statistically significant difference (HR=0.56; 95% CI: 0.36-0.85; p<0.005; not adjusted for multiplicity).

—No new safety signals for Libtayo were observed in this trial. Adverse events occurred in 88% of patients in the Libtayo group and 91% of patients in the chemotherapy group, with serious adverse events reported in 30% and 27% of patients, respectively.

The primary endpoint of the trial was OS, first analyzed in patients with squamous cell carcinoma and then in the overall population. Per the protocol-specified interim analysis, the IDMC reviewed the OS data when approximately 85% of events had occurred in patients with squamous cell carcinoma. Based on the significant impact on OS observed in these patients, the IDMC recommended stopping the trial. Detailed results will be presented at an upcoming medicalMeetingpublished above. The use of Libtayo in cervical cancer is investigational and has not yet undergone comprehensive review by any regulatory authority.

Cervical cancer is the fourth leading cause of cancer-related deaths among women worldwide, with women aged 35–44 being the most commonly affected.DiagnosisCervical Cancer. Nearly all cases are caused by human papillomavirus (HPV) infection. Approximately 80% are classified as squamous cell carcinomas (originating from the cells at the base of the cervix), while the majority of the remaining cases are adenocarcinomas (originating from the glandular cells in the upper part of the cervix). Cervical cancer is usually curable when detected early and treated effectively, but treatment options are more limited in advanced stages.It is estimated that approximately 570,000 women worldwide areDiagnosisCervical Cancer. In the United States, there are 14,500 newly diagnosed cases annually, with approximately 4,000 deaths each year.

Libtayo is an anti-PD-(L)1 inhibitor, a class of cancer immunotherapies that has garnered significant attention. It aims to harness the body’s own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway, thereby inducing cancer cell death, and is indicated for the treatment of various typesTumorpotential. 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 via the PD-1 pathway.

Previously, Libtayo had been approved for the treatment of patients with advanced stages of the two most common types of skin cancer: (1) Libtayo is the first drug approved for the treatment of advanced cutaneous squamous cell carcinoma (CSCC), indicated for patients with metastatic CSCC and those with locally advanced CSCC who are not candidates for curative surgery or curative radiation therapy; (2) Libtayo is the first immunotherapy approved for the treatment of advanced basal cell carcinoma (BCC), indicated for patients with advanced BCC who have previously been treated with a hedgehog pathway inhibitor (HHI) or who are not suitable candidates for such therapy.

In February 2021, Libtayo received U.S.FDAApproval of the third indication: For the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors highly express PD-L1 (Tumor Proportion Score [TPS] ≥50%), specifically: tumors with high PD-L1 expression (TPS ≥50%), metastatic or locally advanced disease, and not suitable for surgical resection or curative chemoradiotherapy.TumorNSCLC patients without EGFR, ALK, or ROS1 alterations.

Libtayo was created and optimized using Regeneron’s proprietary VelocImmune technology platform and is currently being co-developed under the global collaboration agreement between Regeneron and Sanofi for the treatment of various types of cancer. Libtayo’s extensive clinical program focuses on refractory cancers, including skin cancer, cervical cancer, solid tumors, and hematologic malignancies. (Bioon.com)

Original Source: Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival