European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for First-Line Treatment of PD-L1-Positive Metastatic Triple-Negative Breast Cancer
Oct 23, 2021 01:09
CST Updated
01:09
MSD
Pharmaceutical R&D and Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
October 22, 2021 /`Bioon`BIOON/ -- Merck & Co. recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Keytruda (generic name: pembrolizumab), in combination with chemotherapy, for the treatment ofTumorPD-L1–expressing (Combined Positive Score [CPS] ≥10), locally recurrent unresectable or metastatic triple-negative breast cancer, previously untreated with chemotherapy for metastatic diseaseBreast cancer(TNBC) adult patients.
TNBC is an aggressive breast cancer.This approval marks the first time Keytruda has been approved in Europe for the treatment of breast cancer.. This approval was based on the progression-free survival (PFS) and overall survival (OS) results from the pivotal Phase 3 KEYNOTE-355 trial (NCT02819518). The data showed that,Compared with patients receiving chemotherapy alone, patients treated with Keytruda in combination with chemotherapy (one of three regimens: nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin) demonstrated significant improvements in PFS and OS.
Triple-negative breast cancer (TNBC) is a type of breast cancer that tests negative for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) overexpression. It is an aggressive breast cancer characterized by a high recurrence rate within the first 5 years after diagnosis. Approximately 10–15% of breast cancer patients areDiagnosisis TNBC.
Dr. Vicki Goodman, Vice President of Clinical Research at MSD Research Laboratories, stated: “At MSD, we are committed to improving treatment outcomes for patients with hard-to-treat cancers, such as TNBC, worldwide. We are proud of the first approval of Keytruda for breast cancer in Europe. Now, in EuropeTumor“Patients with PD-L1-expressing (CPS ≥10) metastatic breast cancer now have a new option with Keytruda plus chemotherapy, a regimen that has been proven to significantly prolong overall survival (OS). Today’s approval marks a significant advance in the treatment of this aggressive disease.”
KEYNOTE-355 (NCT02819518) is a randomized, two-part, placebo-controlled Phase 3 trial conducted in patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy for advanced disease, evaluating the efficacy and safety of Keytruda plus chemotherapy (one of three chemotherapy regimens) versus placebo plus chemotherapy (one of three chemotherapy regimens) as first-line treatment. In this study, chemotherapy consisted of one of the following three investigator-selected regimens: nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin. The study endpoints included:TumorProgression-free survival (PFS) and overall survival (OS) in PD-L1-expressing patients (CPS ≥1 and CPS ≥10) and in all patients (intent-to-treat [ITT] population). Other endpoints include: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient-reported outcomes (PRO), and safety.
Part 2 of the study enrolled 847 patients, who were randomized in a 2:1 ratio to receive: (1) Keytruda (200 mg every 3 weeks) + chemotherapy; (2) placebo + chemotherapy. Among enrolled patients in each treatment group, approximately 75% had PD-L1–expressing tumors with CPS ≥1 (Keytruda + chemotherapy group n=425/566; chemotherapy group n=211/281), approximately 38% of patientsTumorPD-L1–positive with CPS ≥ 10 (Keytruda + chemotherapy group, n = 220/566; chemotherapy group, n = 103/281).
The results of the final analysis showed:InTumorIn patients with PD-L1–expressing (CPS ≥ 10) locally recurrent unresectable or metastatic TNBC, the Keytruda plus chemotherapy regimen provides a significant survival benefit compared with chemotherapy.. Specifically: Compared with chemotherapy, Keytruda plus chemotherapy reduced the risk of death by 27% (HR=0.73, p=0.0093) and significantly prolonged survival (median OS: 23.0 months vs. 16.1 months). In addition, compared with chemotherapy, Keytruda plus chemotherapy reduced the risk of disease progression or death by 34% (HR=0.66; 95% CI: 0.50-0.88; p=0.0018) and significantly prolonged progression-free survival (median PFS: 9.7 months vs. 5.6 months). (Bioon.com)