Merck's Keytruda Gets Approval for Esophageal Cancer in Japan

Merck & Co., Inc. MRK announced that its PD-L1 inhibitor, Keytruda received approval as monotherapy for the second-line treatment of unresectable, advanced or recurrent esophageal squamous cell carcinoma (“ESCC”) with PD-L1-positive tumors in Japan.

Please note that the drug had received approval for treating a similar indication in the United States in July 2019. With this approval, the drug is currently approved for 13 indications across seven tumor types in Japan.

The approval of Keytruda for ESCC indication in Japan is based on improved overall survival (“OS”) data compared to chemotherapy from the phase III study — KEYNOTE-181. The study (KEYNOTE-181) was conducted in patients with advanced esophageal or esophagogastric junction carcinoma whose tumors express PD-L1 with a Combined Positive Score or CPS of 10 or greater. Data from the study showed that treatment with Keytruda monotherapy achieved a median OS of 10.3 months versus 6.7 months for chemotherapy.

Esophageal cancer is a difficult-to-treat cancer and is the seventh most commonly diagnosed cancer. It is estimated to have been diagnosed in more than 572,000 adults and resulted in nearly 509,000 deaths, globally, in 2018. Moreover, 90% of patients with esophageal cancer have squamous cell carcinomas. Advanced esophageal cancer has poor prognosis in Japan and there is critical need for new treatment options. Keytruda, following this approval, is likely to cater to some of this need.

Additionally, a new dosing regimen of the drug — 400 mg every six weeks — across all adult indications, including Keytruda monotherapy and combination therapy received approval in the country. This dosage is already available in the U.S. market for the drug. The dosage regimen is approved based on interim pharmacokinetic, efficacy and safety data from one cohort of KEYNOTE-555 study.

Earlier this month, Merck announced positive data from the phase III study — KEYNOTE-590 — evaluating Keytruda for the first-line treatment of locally advanced or metastatic esophageal cancer in combination with chemotherapy. Data showed that the Keytruda combo achieved a statistically significant and clinically meaningful improvement in OS and progression-free-survival compared with chemotherapy (cisplatin plus 5-fluorouracil), the current standard of care. The Keytruda combination also achieved significant improvement in objective response rate, the study’s key secondary endpoint.

Merck’s shares have lost 6.1% this year so far against the industry’s 1.9% increase.


Keytruda is a key contributor to Merck’s sales. In a very short span of time, Keytruda has become Merck’s largest product. It is already approved for use in more than 20 indications across several different tumor types in the United States. The drug recorded sales of $6.7 billion in the first half of 2020, up 36.1% year over year. Keytruda sales benefited from strong momentum in the first-line lung cancer indication and launch of Keytruda in multiple new indications globally.

The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1200 studies including 850 plus combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.

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