Upcoming Clinical Trials for Ovarian Cancer

Bradley Monk, MD, FACOG, FACS: As you know, ESMO [the European Society for Medical Oncology annual meeting] was just converted to a virtual meeting. I’m going to lose my airline status because I’m not going anywhere, but it’s right around the corner: the start date is September 18. I’m going to close here, and we don’t really know what’s going to be presented at ESMO, so I don’t want to get people’s hopes up too much. I think we have a sense.

In closing, probably the next time we’re together, we’ll be at ESMO in September, which is just 3 months away. What are you excited about at ESMO, if you’re aware of anything? Even if it’s not at ESMO, what are the upcoming clinical trials that you’re excited about? Matt, if you can’t think of an ovarian one, I know you do a lot of work with endometrial cancer. What’s the next great discovery in your mind?

Matthew Powell, MD: Since you opened the door on endometrial cancer, we might figure out about CDK4/6 [cyclin-dependent kinases 4 and 6] inhibitors in combination with the aromatase inhibitors in endometrial cancer. We might see that at ESMO. We might see some early signals about the value of chemotherapy for our patients with early stage endometrial cancer. There will be a lot of nice things for endometrial cancer, and I’ll let the others talk about ovarian cancer.

Bradley Monk, MD, FACOG, FACS: Within endometrial, we have a phase 3 trial you know well called KEYNOTE-775, which will hopefully lead to the approval of pembrolizumab/lenvatinib around the world in second-line treatment. We have pembrolizumab/lenvatinib accelerated approval here in non-MSI [microsatellite instability]-high tumors, but since you closed the door on endometrial cancer, I’m excited about that KEYNOTE-775. Leslie, what are you excited about as a next, best trial to inform our patients about drugs in the clinic?

Leslie Randall, MD, FACOG: Thanks Brad.

Bradley Monk, MD, FACOG, FACS: You can do a cervical cancer trial too.

Leslie Randall, MD, FACOG: I was going to say that I have to do a cervical cancer trial because there are so many spaces in cervical cancer where we’re learning the value of checkpoint inhibition, and that’s an HPV [human papillomavirus]-mediated, a virally mediated cancer, so there is a lot of high PD-L1 expression, especially in our squamous tumors. There is a lot of rationale to incorporate checkpoint.

We’ve seen it be so disappointing in ovarian cancer. Here’s a disease like endometrial cancer where we’re seeing some efficacy; for all of the tumors types, checkpoint inhibition works better the earlier it’s given. We’re starting to move it up in the lines of therapy, and we’ll hopefully see some not just using it in second-line but maybe seeing it the frontline, metastatic setting.

Then, we’ve got a couple of trials ongoing, and this won’t be ready for ESMO, but there are trials in progress adding checkpoint to chemotherapy/radiation for locally advanced cervical cancer. There are paradigm shifts in cervical cancer treatment.

Bradley Monk, MD, FACOG, FACS: To your point, we have an antibody drug conjugate, not just in ovarian cancer like Dr Birrer talked about, but one against tissue factor in cervical cancer as well. Codeveloped by Seattle Genetics, Inc and Genmab [A/S], that single-arm study, which is called innovaTV-204, should be presented at ESMO. If that’s positive, that could be an accelerated approval for second-line metastatic cervical cancer; then we’ll see.

Also to what you said, we have this trial, KEYNOTE-826, which adds pembrolizumab to platinum-taxane-bevacizumab in first-line metastatic disease. I don’t know if it’ll be at ESMO, but KEYNOTE-775 in endometrial and KEYNOTE-826 in cervical cancer are both transformational.

Shannon, you’re going to have to give an ovarian cancer upcoming trial that you’re excited about, because they already stole the endometrial….

Shannon N. Westin, MD, MPH, FACOG: Yes, I’m excited. I’m hoping IMagyn050 may be reading out by then. I don’t know.

Bradley Monk, MD, FACOG, FACS: Tell them what IMagyn050 is.

Shannon N. Westin, MD, MPH, FACOG: That is one of our upfront studies, but it does not include a PARP inhibitor, which is why we didn’t talk about it today. It combines bevacizumab as well as atezolizumab, a PD-L1 inhibitor, in the maintenance setting. The patients get chemotherapy with bevacizumab, with or without atezolizumab. This study accrued quickly. It has been done for almost a year now, and I know we have a data lock, so hopefully we’ll be seeing some results there, maybe even at ESMO.

To jump on the endometrial train, I’m also interested to see if we’re going to get any results from GARNET for the microsatellite stable group. As you are all aware, dostarlimab is the only drug that demonstrated any activity in microsatellite stable endometrial cancer with a response rate of around 20%. I’m wondering; they updated their data for the microsatellite instability-high group at SGO [the Society of Gynecologic Oncology annual meeting]. Will we be seeing an update for the microsatellite stable group at ESMO? I’d be interested to see.

Bradley Monk, MD, FACOG, FACS: Think about how great it would be for patients. Start on bevacizumab, and you say, “You have HRD [homologous recombination deficiency]; we’re going to give you olaparib.” Then, “Oh, you don’t have HRD; we’re going to give you atezolizumab.”

Shannon N. Westin, MD, MPH, FACOG: Yes, dare to dream.

Bradley Monk, MD, FACOG, FACS: Michael, what upcoming clinical trial results are you excited about? If there are any left.

Michael J. Birrer, MD, PhD: The only comment I would make is that I don’t think I can take another ESMO like the last one. It’s just exhausting, so we need a bit of a respite. I was going to quote what Shannon said, IMagyn050 is the next big step. That trial was supposed to read out in April of 2020.

Bradley Monk, MD, FACOG, FACS: Patients are living; they’re not progressing. Isn’t that great?

Michael J. Birrer, MD, PhD: You’re absolutely right; that may be the case. I’m fascinated by that. There are a lot of other phase 2 trials with developmental therapeutic agents that are coming around. And I always like either at ASCO [the American Society for Clinical Oncology annual meeting] or ESMO to see what’s coming down the pike. IMagyn050 is a big one.

Bradley Monk, MD, FACOG, FACS: There is a lot to be excited about. The good news is that, because these trials are coming, hopefully new approvals are coming. With new trial results and new approvals, hopefully we get to do this again. I enjoy this process. I’ve done a number of these.

I want to thank the OncLive Peer Exchange® team for putting these together. I want to thank you, Drs Birrer, Powell, Westin, and Randall for taking time. Most importantly, I want to thank our listeners. You guys have a lot on your plate. My new words have been Zoom fatigue; it’s a real entity. Trust me, I have it.

I want to thank you for joining us, both our panelists and our audience. Thank you and so long for now. I hope to see you again virtually, but also in person. Thank you.

Transcript edited for clarity.