ImmunoGen, Inc. (NASDAQ:IMGN) is attracting a substantial amount of attention in the biotechnology space as we head into the close of this week, with the company putting out a release outlining some progress for its lead investigative trial.
On the back of the news, Immunogen shares are seeing plenty of movement, with the implications of the development affecting sentiment.
So what happened?
Immunogen reported the latest update as relates to a phase III trial set up to investigate the safety and efficacy of a drug called mirvetuximab soravtansine, when used as a treatment for platinum-resistant ovarian cancer.
The Ovarian cancer side of this indication doesn’t need explaining, but for anyone not familiar with the platinum-resistant side of things, the majority of first-line treatments in this space are platinum-based. As a brief side note, it’s the platinum part of the equation that dictates toxicity and tolerability, but we won’t get too deep into that right now.
What’s important to recognize is a that some patients aren’t particularly responsive to platinum-based chemotherapy and, in this group, an alternative treatment is necessary to try and facilitate the halting of the progression of the cancer in question.
And that’s where Immunogen’s mirvetuximab soravtansine comes in to play.
Here’s the blurb:
“(The drug is)… An immunoconjugate consisting of the humanized monoclonal antibody M9346A against folate receptor 1 (FOLR1) conjugated, via the disulfide-containing cleavable linker sulfo-SPDB, to the cytotoxic maytansinoid DM4, with potential antineoplastic activity.”
So that sounds pretty complicated, but don’t get too hung up on the definition. Basically, it’s designed to target a receptor that’s expressed by ovarian cancer cells (and especially so in the cells in those patients who are resistant to platinum therapy) and, using this targeting mechanism, can theoretically be a neat way to attach (and ideally destroy) cancer cells.
That’s the theory, at least, but as with all these sorts of investigative therapies, the company has to collect statistically significant data that supports the theory – and that’s what the development program in question here was set up to do.
So how did things play out?
Well, in a nutshell, pretty positively.
The latest news refers to what’s called an interim futility analysis, which is a process normally carried out by a an Independent Data Monitoring Committee (IDMC) (as was the case here) and designed to offer insight into the likelihood of success or failure at a trial’s conclusion, but ahead of the conclusion coming around.
Essentially, it’s a way to ask the question – ‘is it worth us continuing to spend money on this trial to see it through to conclusion?’
And to answer this question, the IDMC un-blinds and takes a look at some of the data collected to date (to a predetermined point in the study) and tries to extrapolate from that data what the likely outcome of the trial will be.
If the result of the review is positive, and the IDMC recommends continuation, it’s generally regarded as a strongly positive sign for the trial’s chances of success at conclusion. If the IDMC review is negative, the opposite is true.
And in this instance, the IDMC has completed its review and suggested that ImmunoGen continue the investigation through to conclusion.
So what does this say about the program?
Well, first up, it’s important to note that a recommendation of continuation doesn’t mean that the trial is a guaranteed success – far from it. It’s based on a small, short-term sample and there’s still plenty of room for error (or non-significance) as the trial continues to play out.
With that said, however, it does suggest that the asset is demonstrating a degree of clinical benefit and – based on this – that the program is going about as well as it could be right now.
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