Merck & Co.'s Keytruda gains US approval for high-risk early-stage TNBC

Merck & Co. announced Tuesday that Keytruda (pembrolizumab) gained FDA approval for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). The company noted that the anti-PD-1 therapy is the first immunotherapy regimen authorised in this indication.

Specifically, Keytruda is approved in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. Merck added that the FDA also converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 to full approval.

The FDA rejected clearance of Keytruda in high-risk early-stage TNBC earlier this year, deeming that further data were needed beyond the pathological complete response (pCR) and early interim event-free survival (EFS) results originally submitted from the Phase III KEYNOTE-522 study. However, in May, the company announced that the study hit its EFS endpoint, with updated findings showing that the Keytruda regimen reduced the risk of EFS events by 37% versus the chemotherapy-placebo regimen.

Building presence in TNBC

"This neoadjuvant and adjuvant combination with Keytruda is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community," remarked Vicki Goodman, vice president of clinical research at Merck Research Laboratories. The drugmaker noted that the conversion of the accelerated approval to full clearance in patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 was also based on confirmatory data from KEYNOTE-522.

Separately on Tuesday, Merck announced that in the final analysis of the Phase III KEYNOTE-355 trial, first-line Keytruda  plus chemotherapy led to a significant and clinically meaningful improvement in overall survival compared to chemotherapy alone in patients with metastatic TNBC whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

Keytruda, which is now approved in the US across 30 indications, generated sales of $3.9 billion in the first quarter of 2021, up 19% year-over-year. For further analysis, read Physician Views Results: Early-stage TNBC data for Keytruda gets resounding thumbs up, and KOL Views Q&A: Keynote-522 is new SOC in early-stage TNBC, but Tecentriq not out of the race, says leading oncologist.

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