ImmunoGen, Inc. (NASDAQ:IMGN) Q3 2023 Earnings Call Transcript

Unidentified Analyst: Congrats on the quarter. Mark, how should we think about the sales trajectory next year from the dynamics of patients on combo of and the use in early line versus discontinuation just due to natural progression. How should we think about the trajectory moving forward? And then two on PICCOLO. How should we think about the regulatory path look like post your PICCOLO final analysis? And do you think the final analysis will give you an efficient leverage for conversation for label expansion next year?

Mark Enyedy: Thanks, Brian. I’ll start. Look, we expect to see continued growth. We will give guidance in conjunction with our earnings call in February of next year when we report our full year results. But for the reasons that Isabel articulated in her opening comments. What we see from our market research is increased testing, and that trend should continue, increasing awareness. Right now, the survival data are not currently in the label and so we can’t directly promote that information with the submission of the SBLA and subsequent approval, we’ll be able to go to the market with that. And what we observed from the market research at this point is with increased education, we also see increase the breadth and depth of prescribing both as it relates to the monotherapy as well as in combination.

We think there are rising treatment rates. So this is a new therapy and an area of unmet need. We’ve pointed out earlier that this is the first drug approved specifically in ovarian cancer in almost the last decade. And so the expectation here is that treatment rates will increase. And then in particular, with the MIRASOL data, we have the ability to compare and contrast against the standard of care. And when we do that, what we observed again in the research is an inclination to use the drug earlier in the treatment cascade. And so we do anticipate these questions over the course of the call and today. And so — what I would say again is that we do expect continued growth, but I think it’s also fair to say that coming off of $100-plus million base, the slope of the curve will not be as steep as it was in the past couple of quarters.

Michael Vasconcelles: And this is Mike. Regarding — yes. This is Mike. Regarding your — yes, your second question — so first of all, let’s just keep in mind where we’re at, right? This is a foundational data that will unequivocally be clinically meaningful in this patient population. And the reason that the full data set won’t be available until mid-2024 is because of the importance of presenting mature durability of response data. And just to keep in mind, the last patient was enrolled in this study early this year. So it gives you a sense of of the importance of what that mature response durability data will be. I fully expect, given what we know today, that these data will support compendia listing eventually when we see the full data. And I’d like to reserve judgment on dialogue with regulatory authorities until we have that full data because there’s just no way to put an overall objective of response rate into context with that the durability of response.

Operator: Our next question coming from the line of Alexandra Ramsey [ph] with William Blair.

Unidentified Analyst: Congrats on all the progress this quarter. So two quick questions. I guess first on PICCOLO. That 48% response rate that you mentioned that you’ll present — potentially presented the full data. I just want to confirm that, that’s a confirmed 48% response rate? And then, looking at the MIRASOL data presented earlier at ESCO, it appears that the PARP-treated patients actually responded better than the PARP naive patients. So I was just wondering if you could provide some color on why that might be the case?