Danny Rischin, MD, MBBS, FRACP
The PD-1 inhibitor cemiplimab (Libtayo) as monotherapy and in combination with hypofractionated radiotherapy demonstrated antitumor activity with a tolerable safety profile in patients with metastatic or recurrent cervical cancer, according to data presented at the 2018 ESMO Congress.
, lead study author Danny Rischin, MD, director of the Division of Cancer Medicine and head of the Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia, discussed the potential of cemiplimab in patients with cervical cancer.
OncLive: Please provide an overview of this cervical cancer study.
Rischin: This is a trial of cemiplimab, a PD-1 monoclonal antibody. There were multiple expansion cohorts, and there were 2 cohorts of patients with advanced or recurrent cervical cancer. One of those cohorts was cemiplimab monotherapy, and the other was cemiplimab with radiotherapy given 3 times in the same week of the treatment program. There was 1 PR in each cohort. Some patients had what we call durable disease control—at least 3 months without progression.
What was the rationale for testing cemiplimab in this patient population?
In the phase I study, there were multiple cohorts. The [data with] cutaneous squamous cell carcinoma came out of the same study. We saw very promising data and remarkable activity, which led to the subsequent studies and FDA approval of the drug in that space. In cervical cancer, cemiplimab has modest activity, similar to what has been seen with other checkpoint inhibitors. It has led to the phase III study of looking at this in the second-line setting against chemotherapy, which we know has not been very effective.
What are the next steps following these results?
There is a phase III study underway for patients with metastatic or recurrent disease who have progressed after first-line chemotherapy. They are usually treated with platinum-based regimens and often with bevacizumab (Avastin). Once they progress on that, there are very few treatment options. In this phase III study, patients are randomized to either cemiplimab or second-line chemotherapy.
What is the biggest unmet need in cervical cancer?
It is certainly in the second-line setting of treatment, where this study is being conducted. There are no efficient therapies here. This is particularly an issue globally, where this disease is quite common. The opportunity to explore this in an earlier setting of the disease is something that we are interested in.
Rischin D, Gil-Martin M, Gonzalez-Martin A, et al. Cemiplimab, a human PD-1 antibody, in patients with recurrent or metastatic cervix cancer: interim data from phase I cohorts. In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract 958P.
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