New Biological Insights and Recent Therapeutic Advances in the Management of Lung Cancer: A Clinical Investigator Think Tank
Perspective on the SQUIRE study of necitumumab combined with cisplatin/gemcitabine in advanced squamous cell NSCLC
3:36 minutes.
TRANSCRIPTION:
DR LOVE: So I want to move on and now also talk about another agent where we’ve seen some data recently, this time in squamous cell, and kind of get your take on that, and that is the anti-EGFR antibody necitumumab. Anne, can you talk about the paper presented at last ASCO meeting on that? DR TSAO: Sure. So this was the SQUIRE trial. And so this was a Stage IV carcinoma study. And it randomized patients for cisplatin/gemcitabine with or without the necitumumab. And there was a maximum 6 cycles of therapy of the doublet or the triplet, and then the necitumumab was given as a maintenance therapy, whereas the chemotherapy-only arm just had 6 cycles of the chemo and that was it. There was no selection based off of EGFR immunohistochemistry. Any squamous cell could go on. Now, the primary endpoint was overall survival, and then secondary were PFS, response and safety. And the bottom line to the trial was that there was really no difference at all in terms of response rate. It was 31% with the necitumumab versus 29% with the chemo alone. Disease control rate really wasn’t that different either. There was a statistically significant difference, though, in median progression-free survival, but the median PFS wasn’t, I would argue, not that significantly different. It was 5.7 months with the addition of necitumumab versus 5.5 with chemo alone. Now, what we really are seeing discussion about this agent is in the overall survival. The median overall survival was statistically significantly different. And it was 11.5 months with the necitumumab versus 9.9 with the chemotherapy alone. And so based off of this, necitumumab now has become discussed as a potential front-line option for our squamous cell carcinoma patients. I believe they are seeking FDA approval. I’m not sure where they are in terms of that development process, but it’s been one of the topics in thoracic oncology that we’ve all been talking about. DR LOVE: So Corey, what’s your take on this? Is this a drug you’d like to use? Do you ever use cetuximab, incidentally? DR LANGER: I have, but on clinical trials, not off clinical trials, in combination with weekly taxane and carboplatin. I’d consider it. It’s not yet approved, so our use of this will be highly contingent on its approval. And if the FLEX trial is any precedent, it would not shock me if this drug does not get approved. DR LOVE: Of course, the FLEX trial was looking at cetuximab. Again, Dave, if this drug were available, would you use it? Do you ever use cetuximab? DR SPIGEL: No. But that has more to do with the hypersensitivity problems we’ve had and death. I’m not sure. I am skeptical this will get approved. But your hypothetical scenario, would I use it if it were out there outside of a study? I probably would consider it. DR LOVE: Do you find this, like, more impressive than the cetuximab FLEX data? DR SPIGEL: No, it’s funny. When you sit with Dr Pirker, he, of course, feels these trials are very similar. And I could see why. I mean, this one didn’t really show a difference in response rate. The PFS was a little better. The OS looks like REVEL, the ramucirumab data advantage. So I don't know. This one just didn’t resonate with me as much when I saw the presentation. I agree with Corey. I’m skeptical this will get approved, but I guess we’ll see. |