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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.
In Phase III clinical trials, Merck’s Keytruda (pembrolizumab) proved to be superior to chemotherapy for progression-free and overall survival of patients with non-small cell lung cancer whose tumors express high levels of PD-L1. An independent data monitoring committee recommended the trial be stopped and patients receiving chemotherapy switch to treatment with Keytruda, the company said in a June 16, 2016 press announcement. Data from the Phase III KEYNOTE-024 trial has yet to be released.
The most recent study results may present Keytruda as a first-line treatment for lung cancer, and represents an important step for the company, which has seen significant return in its immuno-oncology program. Merck is currently involved in multiple clinical trials to investigate the likelihood that Keytruda will be effective for the treatment of other types of cancers. The company’s pipeline indicates the drug is currently being investigated in more than 30 tumor types of cancers.
According to a report inThe Street, Keytruda is the first check-point inhibitor for the treatment of first-line lung cancer that has “demonstrated superiority” to standard care. In a June 16, 2016 note to investors, Mark Schoenebaum of Evercore ISI noted that Keytruda may have some competition in the near future with the release of results from Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) trial, CHECKMATE-026, at the conclusion of the third quarter. Opdivo is also being tested for the treatment of patients with first-line lung cancer and is a PD-1 inhibitor. Schoenebaum pointed out that Merck’s trial was performed on PD-L1 high expressers, approximately 25â30% of the first line population, in comparison to the BMS trial which also includes low expressers, approximately 70% of the first line population. This could create a differentiation in the first line label, if BMS is successful with low expressers, Schoenebaum said.
Keytruda was granted marketing authorization by the European Commission in July 2015, following a September 2014 approval from FDA. The drug is also indicated for the treatment of patients with unresectable or metastatic melanoma. Keytruda is administered to patients through a 30-minute intravenous infusion every three weeks.
Source: Merck, Evercore ISI