Here’s what happened.
This first one is rooted in a phase III trial that was set up to investigate the impact of a combination therapy of both Opdivo (nivolumab) and Yervoy (ipilimumab) in a population of patients suffering from first-line advanced non-small cell lung cancer (NSCLC) and whose tumors have high tumor mutation burden (TMB).
The trial was called CheckMate-227 and was set up to compare the combination to chemotherapy as a monotherapy and, as per the latest news, it looks as though there may be some benefit to treating this population with the combination as opposed to just chemotherapy. Just how much benefit there is remains unclear though.
The trial hit on its co-primary endpoint of progression-free survival (PFS) but, while we got that news, the company didn’t report the data in detail and there are some concerns among investors that Bristol-Myers may have changed the design of the trial to concentrate on a subset of patients without explicitly saying so.
If this is the case, the reliability of the data comes in to question. Not reliability in the sense that the PFS endpoint was actually missed, but reliability in the sense that the data can be used to underpin a strong argument for regulatory approval.
All eyes are now on another co-primary endpoint, overall survival (OS), as well as the detailed presentation of the numbers that led to the PFS hit, which Bristol-Myers reports that it will present at a future data presentation.
BMY has picked up a percentage point of strength on the back of the recent news but there’s a good chance we will see things flatten out throughout the remainder of the week as markets revise to reflect the uncertainty surrounding the results. There is also extreme general market volatility at the moment that is doing a number on equity valuations across the board.
Spectrum put out data from a trial called ADVANCE this week. The study was set up to investigate the potential use of a drug called Rolontis in an indication of chemotherapy-induced neutropenia in patients with early-stage breast cancer. The current standard of care in this indication is called pegfilgrastim and the ADVANCE trial compared the two assets, head to head.
As per the latest news, the trial demonstrated the non-inferiority of Spectrum’s asset as compares to the pegfilgrastim SOC, meaning the trial is classed as scoring a primary endpoint hit.
This one brought about a bit of a mixed response. The company initially ran up on the news, spiking during the morning session to highs in and around $22.20 a share on Monday. However, as the session progressed, these gains deteriorated and Spectrum closed out around 2% down on its preannouncement market capitalization.
This shouldn’t be taken as indicative of a negative market interpretation of the news, however.
Wider global markets took a hit on Monday, as we all know. The accepted narrative is that inflation in the US could push the Fed to raise interest rates, but who knows what the actual reason is. This has dampened the impact of any positive news for most companies, such as that which Spectrum reported, in terms of upside movement.
How the markets will fare throughout the remainder of the week remains to be seen and this uncertainty means it’s tough to say where Spectrum goes between now and Friday, even in the wake of a positive pipeline based development.
Regardless, we expect sentiment to stay pretty positive heading into the next major catalyst for this program – the submission of a regulatory registration application.
There’s an ongoing Phase III trial investigating the same asset (but that will likely require a separate filing) that Spectrum wants to wrap up before it submits to the FDA for the neutropenia/breast cancer indication. This trial is expected to close out at some point between now and the end of the second quarter, with company management expectations putting a Biologics License Application (BLA) submission during the fourth quarter of 2018.
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