We had a relatively quiet start to the week in the biotech space this week, with the US Independence Day celebrations putting a dampener on volume throughout the Monday and Tuesday sessions. Heading into the latter half of the week, however, things really started to pick up again and we have seen a number of companies move on various inputs in the sector. Two of these inputs affected two of the biggest names in healthcare, and these two companies will be the focus of our Biotech Movers discussion today.
The two companies in question are Bristol-Myers Squibb Company (NYSE:BMY) and Merck (NYSE:MRK).
So, let’s kick things off with Bristol-Myers Squibb.
Bristol-Myers Squibb is trying to get a drug called Opdivo to market as a therapy for patients suffering from late-stage melanoma who are at high risk of recurrence following surgery. Many reading (most, perhaps) will already be familiar with this asset. It is a very well-established cancer treatment and is used as a standard of care in a whole host of different cancer types, including melanoma (skin cancer), non-small cell lung cancer, bladder cancer, kidney cancer, squamous cell cancer of the head and neck, Hodgkin’s Lymphoma, and urothelial carcinoma. Standard use comes either as a monotherapy or in combination with another asset (generally, a chemotherapy type asset) and it has shown to be incredibly effective in extending survival and inducing cancer regression. However, there are also a number of pretty severe side effects associated with the treatment, primarily rooted in the way it affects the immune system. As such, people receiving Opdivo need regular checks to ensure that they are able to tolerate the drug and many discontinue treatment based on their inability to do so.
This aside, Bristol-Myers Squibb still generates a huge portion of its revenues from the drug, recorded as $3.8 billion during 2016, up from a little over $900 million during 2015.
So, the latest news relates to a phase 3 study set up to demonstrate safety and efficacy in the above noted late stage melanoma indication and, specifically, addressed an interim analysis the study in question.
And as it turns out, things look pretty good.
The drug met its primary endpoint at interim, demonstrating superior recurrence-free survival (RFS) compared to Yervoy (Another Bristol-Myers Squibb drug) in the target population.
This was something of a surprise result as Yervoy is generally regarded as the premium asset in this indication and markets are responding accordingly. The company traded from lows in around $55.5 a share midsession on Wednesday to close out at $56.34. For another company, a smaller company, this may not seem to big a move, but, for a company the size of Bristol-Myers Squibb, it’s relatively substantial.
Data from the trial will be presented at a near-term medical conference as opposed to PR publication (which is pretty much standard at this end of the healthcare space) so we will be following up on the implications of this trial as and when said presentation takes place.
Moving on, let’s look at Merck.
Again, this one relates to a blockbuster asset for the company in question and, this time around, it’s Keytruda. Likely, again, many will already recognize this asset. It is also a standard of care treatment in oncology, used to treat a range of cancers including head and neck cancer, Hodgkin lymphoma, bladder cancer and some types of skin cancer.
Unlike Bristol-Myers Squibb, however, Merck wasn’t able to impress markets with the latest news.
The company just put out news that it has placed a clinical hold on three combination studies of Keytruda, called KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023. The three studies were set up to investigate potential benefit in patients with multiple myeloma, when the drug was combined with two established chemotherapy assets called pomalidomide and lenalidomide (Keytruda and pomalidomide or Keytruda and lenalidomide, not all three drugs together).
Early data from the trial indicated some degree of clinical benefit, but as per a mid-stage analysis, the company has determined that the risks associated with combining these treatments in this patient population outweigh the potential benefits, and this risk-benefit analysis has driven the decision to halt the study.
We don’t have too much information about what actually happened to these patients, but we do know that the halt shouldn’t impact any other ongoing Keytruda studies. As such, while it is something of a setback, markets aren’t responding too negatively to the news – Merck is down around 1% subsequent to the announcement.