ROSELLA Trial Highlights Safe, Biomarker-Free Option for Platinum-Resistant Ovarian Cancer: Brian Slomovitz, MD

Brian Slomovitz, MD, of Mount Sinai Medical Center and GOG Partners, and an investigator on the phase 3 ROSELLA trial (NCT05257408), spoke with The American Journal of Managed Care^® about the safety profile of relacorilant combined with nab-paclitaxel (Abraxane) for patients with platinum-resistant ovarian cancer, as presented this past Monday at the 2025 American Society of Clinical Oncology Annual Meeting.

He also discusses the significance of the treatment not requiring biomarker selection and shares ideas for future research to build on the ROSELLA trial's findings.

Watch parts 1 and 2 of the interview to learn more about the trial results and their broader implications for this patient population.

This transcript was lightly edited; captions were auto-generated.

Transcript

What should clinicians know about the safety profile of the relacorilant plus nab-paclitaxel combination when considering it for patients with platinum-resistant ovarian cancer?

Number one, and it's always important, there were no new safety findings. Anything that we knew previously about the drug, we didn't find anything new. In this capacity, there was some GI [gastrointestinal] toxicity, which was manageable. There were some hematologic toxicities, which were manageable.

Even when we adjusted for the duration of exposure, the incidence rates of both neutropenia and anemia were comparable between the study arms, so longer exposure when we found that there was a comparable risk of side effects.

Bottom line, and I could say this from my personal experience, I was one of the leading recruiters in the country. It's a tolerable regimen. It's something that I think our patients are going to do just fine with. As they did on trial, they should be doing well with it off-trial, based on the results of this study.

This regimen demonstrated positive efficacy and a favorable safety profile without requiring biomarker selection. What is the significance of this? How might it influence treatment access and clinical adoption?

The management of advanced recurrent, or heavily pre-treated recurrent, ovarian cancer is not easy, but a regimen like this is almost as easy as you can get. It's an oral therapy, it's well tolerated.

I can tell you, on the clinical trial, without having the biomarker needed, we're able to get patients on quickly. A lot of our patients, once they're diagnosed with recurrence, or if they're diagnosed that they're not responding to a treatment, they want to get into something as soon as possible. The absence of requiring a biomarker here allows for that in this setting.

The oral availability is phenomenal. They need to get the injection for the chemotherapy, but it doesn't require increased time in the chemotherapy suites.

Looking ahead, when might this treatment become available to patients? What further research, if any, is needed to expand on these findings?

As far as when it's available, I can't really comment on the regulatory process, or I can't predict the regulatory process. When, and hopefully if, it's approved, and I anticipate it would be, hopefully it's done as soon as possible.

Then, once it's approved, then, get it to the patients as soon as possible. One of the nice things, again, with the lack of biomarker testing, we don't need to have that companion diagnostic for these patients. It'll be available for all patients with this disease.

Future directions, we have a positive finding in the platinum-resistant ovarian cancer [population]. We always consider moving it into earlier lines of therapy. Will it work in platinum-sensitive disease? Perhaps, one day, we'll find out it works in the frontline setting.

Maybe even for other diseases. I do a lot of work in endometrial cancer, and I would come up with ideas, hopefully, that we could further investigate this agent in that disease, as well.

I think it's exciting. It's not the end of the story, but, let's say, the first chapter is very promising and encouraging for our patients.