Experts Preview Key Presentations to Watch in Gynecologic Oncology at ASCO 2025

Dana Chase, MD

With the 2025 ASCO Annual Meeting on the horizon, OncLive® spoke with leading gynecologic oncology experts to discuss key clinical trial data anticipated at the conference.

Exclusive insights were shared by:

• Dana Chase, MD, an associate professor of obstetrics and gynecology in the Division of Gynecologic Oncology at UCLA Health
• Premal Thaker, MD, the David G. and Lynn Mutch Distinguished Professor of Obstetrics and Gynecology, director of Gynecological Oncology Clinical Research, and interim chief of the Division of Gynecologic Oncology at Washington University School of Medicine in St. Louis, Missouri
• Rachel Grisham, MD, section head of Ovarian Cancer and director of Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center Westchester in New York
• Bradley Monk, MD, a gynecologic oncologist and medical director of the Late-Stage Clinical Research Program at Florida Cancer Specialists & Research Institute in Palm Beach
• Ritu Salani, MD, director of the Division of Gynecologic Oncology at UCLA Health and professor of obstetrics and gynecology at the David Geffen School of Medicine

Read on to learn why these experts believe these studies could signal a shift in the treatment paradigm across gynecologic malignancies—and what this could mean for future clinical decision-making.

Ovarian Cancer

Abstract LBA5507: ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72)

Session time: June 2, 8:00 am to 11:00 am CDT

Chase: [Patients with] platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer [have] an unmet need. Recently, we've had some impressive data for [patients with] folate receptor alpha [FRα]–high [disease]. They have this option of using mirvetuximab soravtansine-gynx (Elahere) in the platinum-resistance setting, which has shown both an event-free survival and a remarkable overall survival [OS] advantage; however, in the other [approximately] 70% of patients that don't have that [FRα] biomarker, we still need options, and this is really a novel combination of [relacorilant] with nab-paclitaxel [Abraxane].

Some of us use nab-paclitaxel in clinical practice, but we haven't really had a phase 3 study that uses it specifically for [patients with] platinum-resistant ovarian cancer. To use this oral medication [relacorlitant] to try to improve the efficacy of a standard-of-care chemotherapy is exciting for those patients who don't have the FRα biomarker. This is potentially an alternative for the patients who aren't great candidates for mirvetuximab soravtansine.

Premal Thaker, MD

Thaker: As we all know as clinicians who take care of these patients day in and day out, once a patient recurs, every patient ultimately, sadly, becomes platinum resistant, and we need novel opportunities for these patients.

One of the things that makes me super excited about [relacorilant] is that it doesn't have a biomarker. It's always nice to have a medication that [has] wide applicability to a patient population. I'm all in favor of precision medicine, but it's very disappointing when you see a patient who does not have that target and not have something novel to offer them. This gives us, as oncologists, an opportunity to treat many more patients.

What I think is really interesting about [relacorilant] is the fact that it can hopefully overcome some of the resistance pathways, which has been seen preclinically, and now we're also seeing the results in a larger phase 3 trial.

Rachel Grisham, MD

Grisham: Relacorilant is an interesting drug. It’s a glucocorticoid antagonist that is meant to decrease the effects of the glucocorticoid receptor on cancer cell growth. The phase 2 study [NCT03776812] had shown some interesting results and also found the combination to be relatively well tolerated. The press release said that the phase 3 [ROSELLA trial (NCT05257408)] is positive in terms of both progression-free survival [PFS] and also meaningful difference in OS, so I'm really excited to see what [the data] look like, both in terms of safety and efficacy.1

Abstract LBA5506: FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC)

Session time: June 2, 8:00 am to 11:00 am CDT

Bradley Monk, MD

Monk: As you know, we’ve had chemotherapy maintenance, bevacizumab [Avastin] maintenance, and PARP maintenance. Ultimately, what’s the role of immunotherapy? We’ve added immunotherapy twice to two regimens called [the phase 3 DUO O trial (NCT03737643) of durvalumab (Imfinzi) and olaparib (Lynparza)] and [the phase 3 KEYLYNK-001 trial (NCT03740165) of pembrolizumab (Keytruda) and olaparib].

However, those studies were difficult to interpret. [The phase 3 FIRST trial (NCT03602859)] will be the first study to be more interpretable. [The regimen] includes chemotherapy, and [dostarlimab-gxly (Jemperli)] is given during both chemotherapy and PARP [inhibition]. The reason that’s a wonderful study is because it is easily interpreted. In other words, does immunotherapy add to the activity of PARP [inhibition]? DUO-O and KEYLINK, although they addressed the same—or at least a similar—question, were more complicated to interpret.

[Secondly], the space is a little slow because our tumors are rare. It’s not that we’re not trying. Fortunately, these tumors are less common than the more common tumor types you’re familiar with—breast, lung, gastrointestinal, prostate, and so on. And one of the emerging opportunities to monitor patients is cell-free DNA. Cell-free DNA can be used, in one way, to molecularly profile the tumor, but a distinct benefit—potentially—of cell-free liquid DNA is monitoring minimal residual disease.

Grisham: The [FIRST] study is another study looking at [the] use of immunotherapy in our patients with ovarian cancer, and this is something we've been trying to figure out for a long time, both in the recurrent setting and the up-front setting. It's a confusing space because oftentimes PD-1 inhibitors have had somewhat disappointing results for our patients with ovarian cancer, despite all the wonderful benefits they've brought to patients with other types of cancer, such as endometrial cancer and cervical cancer.

Recently, we’ve seen results from the DUO-O study, which did meet its PFS end point, and Matthew A. Powell, MD, of Washington University School of Medicine, presented the results of the KEYLYNK study, which also met its PFS end point.

From the press release, the FIRST study also met its PFS end point, looking at the combination of [dostarlimab] with up-front chemotherapy and [niraparib], with or without bevacizumab.2 I’m excited to see what those data look like, and as we continue to look at these different studies side-by-side, we’ll try to determine if there is a place for PD-1 inhibitors in our first-line treatment of ovarian cancer.

Abstract 5516: A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial

Session time: June 3, 8:00 am to 9:30 am CDT

Thaker: I'm excited [to] be presenting the [phase 1/2] OVATION 2 trial [NCT03393884] data, which look at a novel immunotherapy IMNN-001, which is a plasmid gene formulation of IL-12 that's given concurrently with standard-of-care chemotherapy. The reason I'm excited is because all of us in ovarian cancer have been very excited about immunotherapy. However, looking at the checkpoint inhibitor data so far to date, we haven't really seen those robust changes or improvements in OS.

We all know that patients want immunotherapy to work. They see it working in so many other cancers, so it's nice that we're maybe harnessing the adaptive and the innate systems of our immune system with the use of IL-12.

IL-12 has been around as a cytokine for since the 1990s, and although people have been trying to harness it, because of [adverse] effects, we have not been able to effectively [deliver] it to patients. Now we're able to [administer] it intraperitoneally, which is a novel route, and where ovarian cancer really affects patients—around the abdomen and pelvis.

We can give the drug where the disease is, as well as give systemic chemotherapy. In the trial, we were able to randomly assign patients who were receiving neoadjuvant chemotherapy.

Cervical Cancer

Abstract 5502: Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses

Session time: June 2, 8:00 am to 11:00 am CDT

Ritu Salani, MD

Salani: [The findings from the phase 3 CALLA trial (NCT03830866)] will help us understand the possible role of circulating tumor DNA [ctDNA] in the management of patients with cervical cancer. This dataset will be the largest to date and may help identify patients at high risk for recurrence or improved outcomes.

Monk: The CALLA trial in cervical cancer that added [durvalumab] to chemotherapy and radiation in [newly diagnosed], locally advanced cervical cancer. What CALLA shows is that even though the cancer is gone, as you would think, if there’s ctDNA in the blood, that patient is in trouble. However, the opposite and more optimistic approach is, if the [ctDNA] resolves, then that patient has an excellent prognosis. Now, we [could] begin to do trials based on this idea: [ctDNA] clearance. It's also going to show, interestingly, the role of HPV. Obviously, cervical cancers are caused by HPV, but we're not trying to defeat the virus, because that's very difficult. However, we are trying to defeat the cancer, so tumor DNA is more impactful.

Chase: The CALLA analysis looking at ctDNA and whether it’s associated with relapse and/or survival is really important. These patients with locally advanced cervical cancer—some of them can be cured—but a good proportion have persistent or recurrent disease.

The question is, when you finish chemoradiation in a patient with locally advanced cervical cancer, are they truly in remission? Is there really no evidence of disease? We know that sometimes, despite imaging showing no evidence of disease, some patients experience a rapid regrowth or recurrence of their cervical cancer.

It will be interesting to see if ctDNA can help identify those patients who are not going to do as well—because then we might consider additional therapy for those patients earlier. That could potentially be very clinically relevant and helpful.

We’ve all had those patients who, for example, have stage III cervical cancer, complete their chemoradiation, and their post-treatment imaging shows no evidence of disease. Then they recur quickly, or you just feel uncertain about discharging them and saying, ‘I’ll see you in 3 months,’ because you’re not totally confident that they’re truly disease-free.

If we can have a tool to help identify patients who are unlikely to do well after chemoradiation despite a no-evidence-of-disease scan, that would be very clinically helpful.

References

1. Primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News Release. Corcept Therapeutics. March 31, 2025. Accessed May 19, 2025. https://ir.corcept.com/news-releases/news-release-details/primary-endpoint-met-corcepts-pivotal-phase-3-rosella-trial
2. GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer. News release. GSK. December 20, 2024. Accessed May 19, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-first-trial-met-its-primary-endpoint-of-progression-free-survival-in-first-line-advanced-ovarian-cancer/