Merck (MRK) Keytruda Gets CHMP Nod for Severe Breast Cancer

Merck & Co., Inc. MRK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of its anti-PD-1 therapy Keytruda (pembrolizumab) for a breast cancer indication. The company is seeking a regulatory nod for Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score ≥10).

A potential approval in this indication will mark Keytruda’s first approval in the breast cancer setting in Europe. Per the company, TNBC is an aggressive and difficult-to-treat cancer, which affects around 10-15% breast cancer patients. The same Keytruda combination regimen received was approved by the FDA last November for breast cancer patients in a similar treatment setting.

The CHMP recommendation was based on positive data from the phase III KEYNOTE-355 study, which evaluated Keytruda in combination with three different chemotherapy regimens, namely paclitaxel, nab-paclitaxel or Eli Lilly’s LLY Gemzar (gemcitabine) and carboplatin in the given patient population. Data from the study demonstrated that treatment with Keytruda plus chemotherapy led to a significant improvement in progression-free-survival (PFS) and overall survival (OS) compared to chemotherapy alone.

The company presented updated data from the KEYNOTE-355 study at the European Society for Medical Oncology (ESMO) Congress 2021 over the last weekend.

Results from the study showed that the Keytruda combo significantly reduced the risk of disease progression or death by 27% versus the same chemotherapy regimens alone as first-line treatment for TNBC patients whose tumors express PD-L1. Median OS for the patients treated with Keytruda plus chemotherapy was 23 months compared to 16.1 months for patients receiving chemotherapy only.

Merck is also evaluating Keytruda in two other clinical studies, which are KEYNOTE-242 and KEYNOTE-355 as a treatment option for mTNBC patients. Data from a recently completed late-stage breast cancer study, KEYNOTE-522, showed that the drug in combination with chemotherapy achieved positive results as a neoadjuvant therapy for mTNBC patients. Merck’s breast cancer clinical development program for Keytruda includes multiple internal and external collaborative studies.

Keytruda is likely to face competition following its entry in the breast cancer segment in Europe from Roche’s RHHBY PD-L1 inhibitor Tecentriq, approved in combination with Bristol-Myers’ BMY Abraxane for treating TNBC in 2019. Tecentriq was the first immunotherapy to receive an approval to treat TNBC in Europe.

Shares of Merck have declined 12.4% so far this year against the industry’s increase of 8.5%.

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Apart from the KEYNOTE-355 study, Merck presented data from two other clinical studies that are evaluating its biggest product Keytruda, which is already approved for treating 30 indications across several different tumor types, at the ESMO Congress 2021.

The company announced the first interim findings from the phase III KEYNOTE-716 study that is evaluating Keytruda in patients with resected high-risk stage II melanoma in adjuvant setting. Data showed that treatment with Keytruda reduced the risk of disease recurrence or death by 35% versus placebo. Median OS is yet to be reached during the interim analysis.

Merck also announced full data from the phase III study KEYNOTE-826 that evaluated Keytruda in combination with chemotherapy with or without Roche’s Avastin (bevacizumab) as the first-line treatment of persistent, recurrent or metastatic cervical cancer. Data showed that Keytruda plus chemotherapy with or without Avastin achieved 33% reduction in risk of death compared to chemotherapy alone or in combination with Avastin.

PFS, median OS and median duration of responses in the Keytruda arm were 10.4 months, 24.4 months and 18 months compared to 8.2 months, 16.5 months and 10.4 months for the comparator arm, respectively. The objective response rate was 65.9% for the Keytruda combo versus 50.8% for chemotherapy with or without Avastin.

The significant outcome of these two studies represents the robust potential of Keytruda in improving the lives of patients suffering cervical cancer or stage II melanoma. A potential approval of these Keytruda regimens is likely to drive robust sales for the drug further.

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Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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