Relacorilant/Nab-Paclitaxel Offers New Option in Platinum-Resistant Ovarian Cancer

Relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) was approved by the FDA as a treatment for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have recieved previous treatment with 1 to 3 prior regimens, including bevacizumab (Avastin), in March 2026.¹ According to Rob Coleman, MD, FACOG, FACS, the regimen serves as a novel therapeutic regimen for patients with platinum-resistant ovarian cancer (PROC).

The regulatory milestone is supported by data from the phase 3 ROSELLA trial (NCT05257408). Clinical efficacy results demonstrated a significant improvement in overall survival (OS). Notably, the magnitude of effect remained consistent between progression-free survival (PFS) and OS, with hazard ratios that aligned across both endpoints. The regimen utilized an intermittent dosing schedule adapted from previous phase 2 investigations, which contributed to a favorable safety profile and high tolerability among participants.

Coleman is a gynecologic oncologist at Texas Oncology, as well as special advisor to the president of the Gynecologic Oncology Group (GOG) Foundation.

CancerNetwork: Where does this relacorilant regimen fit into the treatment landscape and what unmet need does it address?

Coleman: If you follow the ovarian cancer space for any duration of time, you know the unmet need is that we need more regimens for patients who develop resistant disease. This applies to that population. Specifically, where it fits is in the cohort of patients with platinum-resistant disease. In this situation, it also provides insight into patients who also received prior bevacizumab, which is another go-to strategy in both frontline platinum-sensitive and platinum-resistant disease. This fills a great need in the gap existing for that patient population.

Can you speak to the data from the ROSELLA trial and what the OS improvement signifies?

One thing to notice is that the phase 3 AURELIA [NCT00976911] did not show a difference in overall survival. It was not until mirvetuximab soravtansine-gynx (Elahere) arrived that we saw movement in overall survival for this population, which in some respects is a little surprising, because when you think about what happens to a patient who is on therapy for PROC, the timeframe between progression and death is relatively short. There is not much to confound an OS/PFS connection, yet it has eluded us for decades. When [mirvetuximab] first came on scene, we considered that there might be something there; that allowed us to look at the magnitude of impact of something like we saw with ROSELLA, to improve overall survival with a consistent effect between PFS and OS. The hazard ratios between the 2 are essentially the same, which is remarkable. It’s such a tremendous help for our patients to see that kind of sustained benefit.

Results also showed improvement in subgroups, such as patients who progressed on a PARP inhibitor. Are there others you can speak to?

I caution against over-interpreting subgroups. However, efficacy aligned with the primary result of the trial across all subgroups, including ECOG status, geographic region, age, prior PARP inhibitor therapy, BRCA mutation status, and tumor size. These factors confirm the robustness of the efficacy in patients with characteristics typical of those who present with platinum-resistant disease.

It’s statistically invalid to look at a subgroup and say, “Oh, it works here, but it doesn't work in this subgroup” because we don't control for multiple comparisons, and we didn't randomize on the basis of those factors. We have to be careful in that respect. What it does tell us is that this group of patients who were allowed to enroll into the trial came with a set of characteristics that we see in our typical patients who ultimately show up with platinum-resistant disease.

Regarding safety, how did patients tolerate the regimen?

This is a very tolerable regimen. This drug, we’ve seen it used across different disease settings and used in different doses on different schedules, but in this intermittent schedule that we essentially adapted from the randomized phase 2 trial was quite tolerable. We looked carefully at the adverse [effect] profile and it was close between the single agent and the combination, but there’s also more exposure. While longer duration on treatment typically increases the likelihood of potential toxicity, this was not a problem with this regimen.

How easily can this regimen be adopted into practices across the country to reach more patients?

These are the things we love because it has a toxicity acceptance that will be welcomed by patients. It is not burdensome to the patients because of its administration and schedule in the way that it’s given. It will be [quite] easy to adopt.

It was funny because when the FDA announced the approval quite a bit ahead of schedule, I already had people from my practice calling to ask, “When can we get it?” We are very excited.

Who is the ideal patient for this regimen?

The beauty of the randomized trial is that we were able to essentially have a backstop against whether this is something that's more beneficial to patients. We all have patients who've been on taxanes long term, but to know whether the patient is benefiting, specifically from the additional agent or overall general composition of the treatment itself is a little hard to discern. When you have an expectation that half of our patients recur or progress within a 3-month window, once that patient breaches that 3-month window, we're already thinking we've made progress. There are a lot of stories that feel that way. Isolating the impact of the combination is really the value of the phase 3 trial. That’s the major piece of this.

We focus a lot on response because a patient comes in and they've got a tumor we can see on the CAT scan, tell them what the options are, put them on the trial, and say, “We're going to monitor you every time”. In this study, we had blind, independent review, but we basically sit down [with the patient] and say, “Okay, we're going to continue to treat you as long as this is working.” Everybody focuses on the fact that the tumor shrinks to a certain point and meets the RECIST criteria, but that's not how we treat patients. We treat patients to the lack of progression. Every time we get through a CT scan and we skip a discontinuation of treatment because they didn't have measurable progression to stop therapy, it's a win. The expectation is that these patients are going to get 2 cycles and then check out, so we [are so excited] when we can come in and say, “This tumor has not grown to the fact we have to stop treatment”. They keep going as long as it's tolerable. This is a huge win for patients, and they love that.

Obviously, the ideal patient will be the one that meets the eligibility criteria. They've had prior bevacizumab, had 3 or fewer lines of therapy, and are good candidates for PET, for taxane. The beauty of this nab-paclitaxel is that it eliminates the need for the steroids, which patients don't like.

Is there anything else you would like to add?

People need to understand how difficult drug development is in the platinum-resistant space. Patients are tough to treat, and the expectations are that most of these are experiments that are going to fail. To have one that wins needs to be celebrated. I congratulate the teams, the patients, and the families that participated in the research to make this work.

Reference

1. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 25, 2026. Accessed April 3, 2026. https://tinyurl.com/yrxh4y8w