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New trial data for Keytruda in triple-negative breast cancer

Keytruda plus chemotherapy showed significant and meaningful improvement

Merck & Co – known as MSD outside the US and Canada – has revealed additional data for its blockbuster immunotherapy for high-risk, early-stage triple-negative breast cancer (TNBC) following a recent US Food and Drug Administration (FDA) rejection in this indication.

TNBC is an aggressive and hard-to-treat subtype of breast cancer, representing around 15% of all breast cancer worldwide, approximately 300,000 cases every year. Patients who are PD-L1 positive represent a subgroup of about 40% of this total.

The new results – from the phase 3 KEYNOTE-522 trial – showed that Keytruda (pembrolizumab) met the dual-primary endpoint of event-free survival (EFS) for the treatment of high-risk early-stage TNBC patients.

Although detailed results were not revealed, Merck & Co said that, based on an interim analysis, neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone.

“Keytruda is the first immunotherapy to show positive results for event-free survival in patients with high-risk early-stage TNBC, a particularly aggressive form of breast cancer,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

In 2019, Merck & Co revealed analysis of pathologic complete response (pCR) rates from Keynote-522, showing a statistically significant increase in this marker for Keytruda plus chemotherapy compared to chemotherapy alone in the same TNBC patient population, regardless of PD-L1 status.

In March 2021, the US Food and Drug Administration (FDA) issued Merck & Co a complete response letter (CRL) rejecting a supplemental biologics licence application (sBLA) in TNBC, based on the pCR data and early interim EFS findings.

The FDA’s oncologic drugs advisory committee (ODAC) voted 10-0 that a regulatory decision for Keytruda in early-stage, high-risk TNBC patients should be delayed until further data from KEYNOTE-522 became available.

“The improvement in pathological complete response rates initially observed following pre-operative treatment was encouraging, and now that we are seeing the data mature after four years to include a statistically significant improvement in event-free survival, we look forward to working with the FDA and other global authorities to bring this new option to patients as quickly as possible,” commented Baynes.

Article by
Lucy Parsons

14th May 2021

From: Research

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