Skip to NavigationSkip to content

MSD’s Keytruda meets primary endpoint in triple-negative breast cancer

Published on 30/09/19 at 10:41am

MSD have announced results from its Phase 3, KEYNOTE-522 trial that pathological complete response (pCR) in patients with early triple-negative breast cancer significantly increased from 51.2% in the placebo group to 64.8% for those given Keytruda in combination with chemotherapy.

The author of the study Peter Schmid said “we found a 13.6% difference which is a clinically meaningful benefit” when Keytruda was added to chemotherapy prior to surgery.

Further data showed that pCR was 68.9% for Keytruda for patients in the PD-L1-positive population, versus 54.9% for the placebo group, while in the PD-L1-negative population, the rates of pCR were 45.3% and 30.3%, respectively.

The researchers also conducted an interim analysis of event-free survival, the trial’s dual-primary endpoint, with results demonstrating a “favourable trend” for the Keytruda group with a 37% reduction in the risk of progression.

At 18 months, 91.3% of patients given Keytruda were event-free, compared to 85.3% on placebo.

Schmid added: “These are preliminary data, but they provide a strong sign that the addition of immune therapy to neoadjuvant chemotherapy prevents breast cancer recurrence. If we prevent recurrence, we cure more patients, but we need longer-term data for confirmation.”

In July, MSD had reported that the trial met its primary endpoint of pCR, noting that Keytruda is the first anti-PD-1 therapy to achieve this result as a treatment for triple-negative breast cancer.

The study itself enrolled a total of 1174 patients, with the interim analysis having been presented at the European Society for Medical Oncology (ESMO) coming up after a median follow-up of 15.5 months in the first 602 patients.

Nik Kiran

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches