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ESMO conference: Merck's Keytruda combo bests chemo in aggressive breast cancer

Merck & Co. Inc. said a combination of Keytruda and chemotherapy resulted in more remissions than chemotherapy alone in a late-stage study in patients with an aggressive form of breast cancer.

The phase 3 study, named Keynote-522, evaluated the combination of the blockbuster drug and chemotherapy in 1,174 patients with early-stage triple-negative breast cancer, or TNBC.

In TNBC, the three most common types of receptors known to fuel most breast cancer growth — estrogen, progesterone and a protein called HER2 — are not present in the cancer tumor, and thus cannot be targeted to kill the tumor cells, making it more difficult to treat.

About 15% to 20% of patients with breast cancer are diagnosed with TNBC and the disease has a high recurrence rate within the first five years after diagnosis, according to a Sept. 29 news release.

New Jersey-based Merck's best-selling drug Keytruda, or pembrolizumab, works by boosting the immune system's ability to kill cancer cells by blocking healthy cells' PD-1 protein from linking up with a partner arm on the surface of cancer cells known as the PD-L1 protein.

Patients in the trial were given a regimen of Keytruda plus chemotherapy before surgery, followed by Keytruda as monotherapy after the surgery. This regimen was compared against patients who received placebo plus chemotherapy before surgery and also got a placebo after the surgery.

After the treatment, no invasive residual cancer in breast and lymph nodes — also known as complete response or complete remission — was seen in 64.8% of patients in the Keytruda-chemotherapy group versus 51.2% of patients in the placebo-chemotherapy cohort, interim data presented at the European Society for Medical Oncology's 2019 scientific meeting showed.

The improvement with the Keytruda-chemotherapy combination was seen regardless of the prevalence of PD-L1, which helps cancer cells hide from the immune system, in patients before they underwent surgery.

In patients with high PD-L1 expression, the rates of remission were 68.9%, or 334 patients, for the Keytruda regimen versus 54.9%, or 164 patients, who received chemotherapy. In patients with lower PD-L1 expression, remission was observed in 45.3%, or 64 patients, in the Keytruda group and 30.3%, or 33 patients, in the chemotherapy cohort.

Treatment-related adverse events resulting in discontinuation of any treatment occurred in 23.3% of patients receiving the Keytruda regimen and 12.3% of patients receiving chemotherapy before the surgery. The adverse events led to death in two patients receiving Keytruda plus chemotherapy and one patient receiving chemotherapy.

After surgery, adverse events resulting in discontinuation of treatment occurred in 3.3% of patients receiving Keytruda and 1.3% of patients receiving the placebo. The adverse events led to death in one patient receiving Keytruda.

The Merck drug plus chemotherapy was granted a breakthrough therapy designation by the U.S. Food and Drug Administration for the presurgery treatment of patients with high-risk, early-stage TNBC.

Keytruda, which is approved in a number of countries for treating multiple types of cancer, generated global sales of about $2.63 billion in the second quarter.

The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.