Keytruda-Mektovi Combo Deemed Safe in Early Triple Negative Breast Cancer Trial

Keytruda-Mektovi Combo Deemed Safe in Early Triple Negative Breast Cancer Trial
A combination of the immune checkpoint inhibitor Keytruda (pembrolizumab) and the melanoma therapy Mektovi (binimetinib) is safe and well-tolerated by people with advanced triple negative breast cancer, preliminary findings from a Phase 1/2 clinical trial show. Safety data from the Phase 1 portion of the trial was presented in the poster, "Phase I results of the phase I/II study of pembrolizumab in combination with binimetinib in patients with unresectable locally advanced or metastatic triple-negative breast cancer," at the ASCO-SITC Clinical Immuno-Oncology Symposium on Feb. 6 in Orlando, Florida. The ongoing clinical trial (NCT03106415) initially enrolled 12 triple negative breast cancer patients whose cancer was locally advanced and inoperable, or had spread to distant regions in the body (metastatic), and who had received no more than three prior lines of therapy. (The term "triple negative" means that the cancer growth is not driven by estrogen, progesterone, or by the protein HER2.) The primary goal of the initial phase of the trial was to determine the maximum dosage of Mektovi that patients could tolerate without a severe adverse reaction. To test this, patients were split into two groups, each receiving a distinct oral dose of Mektovi. Four of the 12 patients received Mektovi at 45 mg twice daily, while the other eight received it at 30 mg twice daily. All patients were given a consistent 300 mg dose of Keytruda every three weeks, starting two weeks after the introduction of Mektovi. Participants were evaluated for a measure called dose limiting toxicity (DLT), which is defined as experiencing an adverse reaction to the treatment that is severe enough to prevent an increase in dosage. Of the four patients enrolled at the higher dosage level of
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