Merck's Keytruda Fails Triple-Negative Breast Cancer Trial

Merck logo on sign

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Merck & Co. announced that its Keytruda failed to hit its primary endpoint in the Phase III Keynote-119 clinical trial. This evaluated Keytruda for second- or third-line treatment of patients with metastatic triple-negative breast cancer. The primary endpoint was superior overall survival compared to chemotherapy.

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KEYNOTE-119 is a Phase III trial evaluating Keytruda as a monotherapy compared to a physician’s choice of single-agent chemotherapy in metastatic triple-negative breast cancer (TNBC). TNBC is an aggressive type of breast cancer with a high recurrence rate within the first five years after diagnosis. Triple-negative refers to testing negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2. As a result, TNBC does not respond to drugs that target these cancer markers. About 10 to 20% of breast cancers are TNBC.

“Metastatic triple-negative breast cancer is an aggressive and challenging disease to treat, especially after progression on initial standard-of-care treatment,” stated Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “While we are disappointed by the outcome of this monotherapy trial, we are continuing to study Keytruda in earlier stages of the disease and in combination with chemotherapy to address the unmet medical need of patients with triple negative breast cancer.”

Keytruda is a checkpoint inhibitor affecting PD-1. The drug is involved in more than 1,000 clinical trials across a wide variety of cancers and treatment settings. The drug has been approved for various settings in melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, primary mediastinal Large B-Cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, Merkel Cell Carcinoma and renal cell carcinoma.

In this year’s first quarter alone, Keytruda brought in $2.27 billion for Merck.

Merck indicates it will continue to study Keytruda in the early stages of TNBC and in combination with chemotherapy.

In other news, Merck announced it is buying Dallas, Texas-based Peloton Therapeutics in a deal that could hit $2.2 billion. Peloton is a clinical-stage oncology company.

Merck, though a subsidiary, is buying all outstanding shares of Peloton for an upfront payment of $1.05 billion in cash. Peloton will also be eligible for another $1.15 billion based on various regulatory and sales milestones.

Peloton’s lead candidate is PT2977, a novel oral HIF-2alpha inhibitor in a Phase II clinical trial for von Hippel-Lindau disease-associated development for renal cell carcinoma (RCC). The company is planning on beginning patient enrollment in a Phase III trial in patients with metastatic clear cell RCC that has been previously treated.

The drug is also being investigated in metastatic RCC in combination with a VEGFR inhibitor, cabozantinib, and in glioblastoma. The company also has PT2567 in preclinical studies for pulmonary arterial hypertension (PAH).

“This acquisition exemplifies Merck’s strategy to pursue novel therapeutic candidates based on exceptionally promising and innovative research,” stated Roger M. Perlmutter, president, Merck Research Laboratories. “Peloton scientists have applied their unique expertise in HIF-2a biology to develop PT2977, which has already shown intriguing activity in the treatment of renal cell carcinoma. We look forward to advancing this late-stage asset as part of our broad oncology R&D program.”

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