Keytruda (pembrolizumab): extension of indications to add triple negative breast cancer treatment

On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda (pembrolizumab). The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted a new indication as follows:

Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1 of the SmPC).

The combination cut the risk of death by 27% compared to chemo alone in these patients, and helped patients to extend their lives by around 6.9 months to 23 months, according to data reported at this year’s ESMO cancer conference. It also reduced the chances of disease progression or death by 35%. Merck said that Keytruda is the first checkpoint inhibitor in combination with chemotherapy to show a statistically significant improvement in overall survival in previously-untreated patients with a PD-score of 10 or more.

After the FDA approval occurred in July 2021 for the use of Keytruda pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring, the EU approval received in the 22 October 2021 also consolidates Keytruda’s position in TNBC against its main competitor Tecentriq (atezolizumab).

Keytruda is already authorized for treatment of Melanoma, Hodgkin Disease, Carcinoma Non-Small-Cell Lung, Carcinoma Renal Cell, Carcinoma Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck.