Ursula A. Matulonis, MD, on the KEYNOTE-100 Trial Final Results

August 8, 2020

The expert from the Dana-Farber Cancer Institute discussed the study findings which assessed the use of pembrolizumab monotherapy in patients with advanced recurrent ovarian cancer.

In an interview with CancerNetwork®, Ursula A. Matulonis, MD, of the Dana-Farber Cancer Institute, spoke about the final results of the KEYNOTE-100 trial.

The study, which was originally presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, assessed the use of pembrolizumab (Keytruda) monotherapy in patients with advanced recurrent ovarian cancer.

Patients included in the trial were those with epithelial ovarian, fallopian tube, or primary peritoneal cancer, confirmed recurrence following front-line platinum-based therapy, ECOG performance status of 0 or 1, and provision of a tumor sample for biomarker analysis.


So, the trial design was based upon overall response rate via RECIST 1.1 by blinded, independent central review either by cohorts, so cohort A versus B, and then also by CPS score, so 1 or higher 10 or higher. So, for the first primary endpoint, and I'm looking at overall response rate by cohort, the overall response rate for patients in cohort A was 8.1%, and for cohort B was 9.9%. So, for overall response rate for the 376 patients was 8.5. And the disease control rate was 1 of the secondary endpoints and that's the (complete response; CR) plus (partial response; PR) for stable disease more than 6 months. That was around 22% for both for both cohort A and cohort B.

Now, when we actually looked at the response rate, overall response rate based upon CPS score… So, for example, in patients who were in cohort A, less heavily pretreated patients had a CPS score of 1 or higher, responses were 6.9%; for CPS score 10 or higher, that response rate goes up to 11.6%. And then for cohort B, for CPS one or higher, overall response rate 10.2% and that goes up to 18.2% in patients for cohort B, in cohort B, who had a CPS score of 10 or higher. And if I just might point out that the higher CPS scores were more rare. So, in that patient population of cohort B, 10 or higher was only 18 patients. So, for all comers, all 376 patients for cohort A CPS score 1 or higher was 8%. And then for all the patient population, 376 patients, for CPS core 10 or higher, it was 13.8%.