Keytruda’s Label Expansion Could Boost Merck’s Revenue Growth



Keytruda approved for metastatic cervical cancer

In June, the FDA approved Merck & Company’s (MRK) Keytruda for the treatment of metastatic cervical cancer patients whose disease had progressed after or during chemotherapy and whose tumors expressed PD-L1.

The FDA’s approval of Keytruda for the treatment of metastatic cervical cancer was under the FDA’s accelerated approval regulations established via tumor response rate and durability of response.

KEYNOTE-158 trial

The FDA’s accelerated approval of Keytruda for the treatment of cervical cancer was based on the data from the KEYNOTE-158 trial.

In the KEYNOTE-158 trial, 98 patients received Keytruda 200 mg intravenously every three weeks unless the patient showed documented disease progression and unacceptable toxicity. Among the 98 patients in the trial, 77 had tumors that expressed PD-L1 and underwent at least one line of chemotherapy. Among these 77 patients with PD-L1 expression, 14.3% achieved an ORR (objective response rate), with 2.6% of patients achieving a complete response rate and 11.7% of patients achieving a partial response rate. Of the 11 patients who responded, 91% had a duration of response of six months or more.

In the KEYNOTE-158 trial, among 98 patients, 8% had to discontinue the use of Keytruda due to adverse reactions.

According to the National Cancer Institute, 13,000 new cases of cervical cancer are expected to be diagnosed in 2018. The approval of the label expansion of Keytruda by the FDA is expected to boost the revenue growth of the drug in 2018 and beyond. The label expansion of Keytruda will allow Merck to address a larger patient population.

Roche’s (RHHBY) Avastin is an important drug indicated for the treatment of metastatic cervical cancer. Some other drugs used for the treatment of cervical cancer include Novartis’s (NVS) Hycamtin and Bristol-Myers Squibb’s (BMY) Blenoxane.

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