We’re midway through the week and things have already been moving pretty fast. Action across the biotechnology sector is dictated by a variety of inputs but development stage pipeline updates are where the real action lies and – as we head into the bell on Wednesday – there are a couple of key pipeline related events that are going to set sentiment for the day. Here’s a look at which companies are moving, what’s moving each and what’s next for the companies in question.
The two companies in focus for the session today are Bristol-Myers Squibb Company (NYSE:BMY) and Portola Pharmaceuticals Inc. (NASDAQ:PTLA).
First up, then, BMS.
After the closing bell rang on Tuesday, BMS announced top line data from a study called CheckMate-214. The trial was set up to investigate the potential use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab), as compared to an already approved (and pretty well established) standard of care drug called sunitinib. The target indication in this instance was metastatic renal cell carcinoma. Many reading will likely already be familiar with the two assets under investigation here – they are both blockbuster cancer therapies in their own right, with Yervoy generating in $1.1 billion in revenues during the full year 2016 and Opdivo generating (what amounts to just shy of the standard definition of blockbuster status) at $942 million. Both have faced a degree of competition over the last few years, however, and both are set to face further competition from both the generic market and fresh treatment types over the coming decade. As such, BMS has spent a lot of money trying to expand the target indications of the two drugs – with a relatively high degree of success.
The latest efforts have seen the company push the combination program and the most recent news is the latest step along that combination-push pathway.
So what did the results show?
As per the news, the combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. Right off the bat, that’s a positive outcome. However, there’s a catch. The second of the two co-primary endpoints, progression-free survival (PFS), 1.56 months for the Opdivo and Yervoy combo versus 8.38 months for sunitinib. That’s an improvement, but against the trial protocol it’s not statistically significant.
So what’s the takeaway from this data? Well, ideally, of course, BMS would have loved to get a clean sweep on the two co-primary endpoints. The next best thing is a clean profile on the safety side of the equation and one of the endpoints being hit. It’s a two out of three ain’t bad sort of situation.
With this in mind, markets are responding negatively to the news, but far from as negatively as would have been the case if both endpoints had have failed to hit. The company is down a few percentage points and there’s a good chance we’ll see a few more percentage points wiped off as the market opens on Wednesday and normal participation gets underway.
Going forward, we expect this program to continue. BMS hasn’t given any really insightful guidance as to how it plans to progress this combination in this indication, but markets have to remember that this is a deadly cancer with very few effective therapies. As such, even the smallest benefit (against a backdrop of a clean safety profile) will likely be regarded as worthwhile by the FDA.
Moving on, Portola.
Again, this one is a development drug update, but it’s for an asset that’s a little further down the line (in the target indication, that is) than the BMS combo. In this instance, Portola was investigating a drug called AndexXa (andexanet alfa) as a therapy for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. The company initially submitted last year but received a CRL on the submission, which sent Portola tumbling (as a lot rides on this drug) for this company). The most recent news details the fact that the FDA has accepted the resubmission of the BLA that the company hoped would address the deficiencies raised by the FDA.
This one, again, hasn’t had too much of an impact on the company’s market capitalization on release. With that said, there’s a good chance we’ll see a bit of speculative volume flow towards the company in anticipation of the now established PDUFA date of February 2, 2018.