In an interview with PharmaShots, Krishnansu S. Tewari, Professor and Director of the Division of Gynecologic Oncology at the University of California, and Israel Lowy, Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron share their views on the data of Libtayo in cervical cancer patients, presented at ESMO Virtual Plenary.

Shots:

• Regeneron and Sanofi reported positive results from P-III trial of Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on CT
• Libtayo demonstrated an improvement in OS, PFS and ORR vs CT in 2L advanced cervical cancer patients. The data will form the basis of regulatory submissions in 2021
• Additionally, the Phase 3 trial found significant differences in patient-reported outcomes favoring Libtayo over CT

Tuba: What are the key takeaways of the data of LIBTAYO presented at the ESMO virtual plenary?

Dr. Krishnansu S. Tewari: At the ESMO Virtual Plenary, results were presented from the Phase 3 trial evaluating Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy. This is the first Phase 3 trial of immunotherapy in advanced cervical cancer and also the largest randomized trial conducted in this population to date. It's also notable that patients were enrolled regardless of their PD-L1 status.

In many ways, I would characterize this as a landmark trial especially when you consider that patients at this stage of cervical cancer often face a poor prognosis and limited treatment options. With this trial, Libtayo became the first immunotherapy to demonstrate a statistically significant and clinically meaningful improvement in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in recurrent or metastatic cervical cancer, compared to chemotherapy. These gains were not accompanied by a deterioration in the quality of life and are observed in both the overall study population and the squamous cell carcinoma subpopulation.

These results led the Independent Data Monitoring Committee (IDMC) to stop the trial early, and I believe the results support the use of Libtayo as a potential new second-line treatment for women with advanced cervical cancer.

Tuba: Discuss outcomes that are favoring LIBTAYO over chemotherapy.

Dr. Krishnansu S. Tewari: Treatment outcomes were assessed in the overall population, and by squamous cell carcinoma (SCC) and adenocarcinoma subtypes. Notably, Libtayo demonstrated positive results in all three groups for overall survival.

Among the overall population, patients treated with Libtayo experienced significant improvements in OS, PFS, and ORR, compared to chemotherapy. Specifically, Libtayo reduced the risk of death by 31% and reduced the risk of disease progression by 25%. Additionally, Libtayo-treatments experienced a 16% ORR compared to 6% for chemotherapy, per Kaplan-Meier estimates.

 The results were similarly significant in the SCC subgroup, which made up 78% of patients in the trial. Here, Libtayo reduced the risk of death by 27% and the risk of disease progression by 29%. ORR was 18% for Libtayo, compared to 7% for chemotherapy.

While assessment of the adenocarcinoma subgroup was not a pre-specified endpoint, a posthoc analysis demonstrated that Libtayo reduced the risk of death by 44% and reduced the risk of disease progression by 9%. In this subgroup, ORR was 12% for Libtayo, compared to 5% for chemotherapy.

When it came to patient-reported outcomes Libtayo-treated patients were able to generally improve or maintain their baseline Global Health Status/Quality of Life (GHS/QOL) over time, while those treated with chemotherapy experienced a deterioration that became clinically meaningful starting at cycle 8, per the EORTC QLQ-C30.

No new Libtayo safety signals were observed. Furthermore, rates of adverse events (AEs) were generally lower among patients treated with Libtayo compared to chemotherapy, despite a longer duration of treatment exposure with Libtayo. AEs of any grade were observed in 88% of Libtayo patients and 91% of chemotherapy patients, and Grade 3 or higher AEs occurred in 45% of Libtayo patients and 53% of chemotherapy patients.

Tuba: When can we expect the approval of LIBTAYO in cervical cancer?

Israel Lowy: We are currently preparing regulatory submissions and hope to bring Libtayo to patients with advanced cervical cancer as soon as possible. However, we are unable to provide additional details at this time.

Tuba: What would be the targeted geographies for seeking approval?

Israel Lowy: We are currently preparing regulatory submissions and hope to bring Libtayo to patients with advanced cervical cancer as soon as possible. However, we are unable to provide additional details at this time.

Tuba: How much change will it bring economically to the market? How much will the company profit?

Israel Lowy: We generally do not comment on the market potential of any of our approved products. We believe that Libtayo may help address a significant unmet need among this patient population.

Tuba: Discuss Cervical Cancer and its epidemiology

Dr. Krishnansu S. Tewari: Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in women between the ages of 35 and 44. Almost all cases are caused by human papillomavirus (HPV) infection, and approximately 75% are classified as SCC. The remainder is largely adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.

It is estimated that approximately 570,000 women are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new patients diagnosed annually and approximately 4,000 women die each year.

Tuba: How LIBTAYO will be proven a boom in the treatment of cancer in women?

Dr. Krishnansu S. Tewari: If approved, I believe Libtayo has the potential to change the way we treat these patients with recurrent or metastatic cervical cancer who have progressed on chemotherapy. More importantly, this opens up the possibility of bringing anti-PD-1 therapy using Libtayo earlier in the disease course through a well-designed clinical trial.

Main Source: DocWire News

About Dr. Krishnansu Tewari:

Dr. Krishnansu Tewari is an American Board of Obstetrics & Gynecology Certified Gynecologic Oncologist. He is a Full Professor and Division Director of Gynecologic Oncology at the University of California, Irvine.  Dr. Tewari received his medical degree from the University of California, Irvine School of Medicine, and completed his residency in obstetrics/gynecology, as well as his fellowship in gynecologic oncology, at UCI Medical Center.

About Israel Lowy:

Israel Lowy is the Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron.

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