Merck's Cancer Drug Keytruda Positive In Clinical Studies

Merck & Co., Inc. (NYSE:MRK) announced positive data from a phase III study KEYNOTE-024, evaluating its anti-PD-1 therapy, Keytruda (pembrolizumab) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high levels of PD-L1.

In Aug 2016, Keytruda was approved in the EU for second-line treatment of advanced or metastatic NSCLC in patients with tumors expressing PD-L1 and who have received at least one prior chemotherapy regimen.

Incidentally, the drug is already approved in the U.S. for first-line NSCLC indication. In fact, its sales figures are projected to sharply improve, following the latest approval which would allow Keytruda to be marketed in all 28 member countries of the EU apart from Iceland, Lichtenstein and Norway.

Investors must be reminded that in addition to healing lung cancer, Keytruda is approved in the U.S. for treating patients with unresectable or metastatic melanoma. The drug can be administered until the disease progresses or the toxicity level reaches an unacceptable point.

Also, the medicine comes handy for patients whose previously treated metastatic head and neck cancer (HNSCC) relapses.

Merck’s share price movement shows the stock to outperform the Zacks classified Large Cap Pharma industry in the last year. The stock climbed 14.1% compared to industry’s 2.4% increase during the period.



With approximately eight additional months of follow-up, data from the KEYNOTE-024 study demonstrated a superior overall survival (OS) and progression-free survival (PFS) of Keytruda compared to chemotherapy.

The study showed an 18-month OS rate of 61.2% in the Keytruda group, compared to 43% in chemotherapy segment. Also a 12-month OS rate of 70.3% in Keytruda group is pitted against 54.8% in chemotherapy. These results injected more confidence in Keytruda as a first-line curative agent for patients with NSCLC.

In a separate press release, the company announced some encouraging results from a phase II study I-SPY 2, evaluating Keytruda in combination with a standard therapy as a neoadjuvant treatment for in patients suffering from triple-negative breast cancer (TNBC).

Data from the study showed that an addition of Keytruda has increased the estimated pathologic complete response (pCR) rate nearly 60% in patients with TNBC, compared to a modest 20% in standard therapy. While in patients with HR+/HER2- breast cancer, the pCR increased by 34% compared to a 13% in standard therapy.

Keytruda is the first anti-PD-1 therapy to gain an FDA approval. The drug is being studied in over 30 types of cancer. Merck is collaborating with several companies like Amgen, Inc. (NASDAQ:AMGN) , Incyte, GlaxoSmithKline plc (NYSE:GSK) and Pfizer Inc. (NYSE:PFE) for evaluating Keytruda in combination with other regimens.

Zacks Rank

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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