Both Merck (NYSE:MRK) and Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) put out clinical trial data this week and the two companies have moved considerably on the back of the update.
Here is a look at the data we got from each and what it means for both the companies in question and the target populations to which their drugs apply going forward.
Merck
The data that Merck put out derives from a phase 3 pivotal trial for the well known blockbuster Keytruda. This is one of the old-guard immunotherapy assets, having first been approved back in September 2014 in a target indication of advanced melanoma.
Since this initial approval, the drug has picked up no fewer than nine expended indications, including non-small cell lung cancer, non-Hodgkin’s lymphoma, advanced or metastatic urothelial carcinoma and, most recently, in September 2017, metastatic gastric cancer in patients whose tumors express PD-L1.
As per the most recent numbers, Merck generated a little over $1.05 billion in revenues for the third quarter of 2017 and analysts expect the drug will bring in annual sales of more than $4 billion by 2020.
It’s a major part of Merck’s portfolio, but the company isn’t sitting on its laurels.
As per the latest news, which, as mentioned, derives from a phase 3 pivotal trial, Merck is attempting to expand the approved indications further, this time for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer.
The trial was called KEYNOTE-189 and was set up to investigate Keytruda in combination with Alimta and cisplatin or carboplatin, all of which are already approved chemotherapy drugs that are used as first-line standard of care treatments in this form of NSCLC.
The data look very strong. Merck reported that KEYNOTE-189 met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS).
It’s not unusual for larger pharmaceutical companies to report an outcome like this without offering up too much detail with regards to the numbers that support the outcome and this is the case here. Instead, Merck has reported that it intends to present the data at an upcoming medical meeting.
Chances are we will see some further strength as and when these numbers are presented in detail but, even with the lack of insight that came with the recent announcement, markets are trading up on the company considerably.
At close of trade on the day of the data release, Merck was trading for a close to 6% premium on its preannouncement daily open. At a glance, that doesn’t sound like too much of an upside injection. However, when you consider that Merck currently trades for a market capitalization in and around $170 billion, 6% is a substantial shift.
Eiger
Eiger also put out data from a recently completed clinical trial and is moving on the back of the news. Unlike Merck, however, the data hasn’t hit press as positive.
The trial was set up to investigate a drug called ubenimex in a target indication of pulmonary arterial hypertension (PAH), which is a type of high blood pressure that happens when a patient’s arteries constrict, meaning the heart has to pump harder in order to achieve efficient blood flow volume. Anything that forces the heart to work harder than normal is dangerous for obvious reasons and – in this instance – PAH can lead to heart failure if gone untreated.
Ubenimex was designed to increase the production of pro-inflammatory signals important for vessels dilation, which in turn was expected to help increase the diameter of the patient’s blood vessels and reduce the added load that PAH causes on the heart.
The data suggest that it doesn’t work though.
Two endpoints were key to success, one being pulmonary vascular resistance (PVR), which is essentially a measure of blood pressure, and another (the secondary endpoint) being a six-minute walk test.
Ubenimex failed to hit either of these endpoints meaning, while the drug also didn’t show any major safety issues, Eiger has no real choice other than to discontinue the program in this indication.
The company is continuing an investigation into the impact of the same drug in patients with lymphedema and there’s a phase II study set to readout at some point during 2018 in this indication.
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