A Promising Option For Platinum-Resistant Ovarian Cancer

  • The recent FDA approval of relacorilant (brand name Lifyorli) in combination with nab-paclitaxel introduces a new option for platinum-resistant ovarian cancer (PROC), one notable for its efficacy signal, mechanism, and broad applicability. The approval adds a welcome new option where there previously were few.
  • Interim overall survival analysis for the ROSELLA trial demonstrated a clinically meaningful benefit, with a hazard ratio of 0.69 and median OS of 15.97 months with relacorilant plus nab-paclitaxel vs. 11.50 months with nab-paclitaxel alone.
  • In a disease setting where OS improvements are rare and often modest, a gain of approximately 4 to 4.5 months is difficult to ignore.
  • One of the most clinically relevant aspects of this approval is its lack of biomarker dependence, Dr. Dana Chase, a gynecologic oncologist at UCLA, tells SurvivorNet Connect. “This is a treatment that does not rely on a biomarker, meaning more patients can have access to it,” Dr. Chase adds.

The treatment landscape for platinum-resistant ovarian cancer (PROC) has long been defined by incremental gains and limited durability of response. For years, clinicians have relied on sequential single-agent chemotherapies, bevacizumab-based combinations, and, more recently, biomarker-driven approaches such as PARP inhibitors and immunotherapy in select populations. Yet, meaningful improvements in overall survival (OS) have remained difficult to achieve.

The recent FDA approval of relacorilant (brand name Lifyorli) in combination with nab-paclitaxel introduces a new option in this space, one that is notable for its efficacy signal, mechanism, and broad applicability. The approval adds a welcome new option where there previously were few.

“The practicing physician has two newly approved FDA treatments for platinum-resistant ovarian cancer,” Dr. Premal Thaker, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, tells SurvivorNet Connect.  “Recently in February 2026, the FDA approved Keynote B96 treatment regimen of weekly taxol, pembrolizumab and bevacizumab for PROC patients with CPS>1. Now we have a tumor-agnostic option for PROC patients with the use of weekly nab-paclitaxel and relacorilant.”

A Phase III Signal That Matters

The relacorilant and nab-paclitaxel approval is supported by data from the phase III ROSELLA trial, which randomized 381 patients with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.

The study met both of its dual primary endpoints:

  • Progression-free survival (PFS) was significantly improved with the addition of relacorilant, with a hazard ratio of 0.70 and a median PFS of 6.5 months versus 5.5 months with chemotherapy alone.
  • More importantly, the interim overall survival analysis demonstrated a clinically meaningful benefit, with a hazard ratio of 0.69 and median OS of 15.97 months compared to 11.50 months.

In a disease setting where OS improvements are rare and often modest, a gain of approximately 4 to 4.5 months is difficult to ignore.

“The improved OS is the benchmark to get patients meaningful treatment options,” Dr. Thaker notes.

No new safety signals were identified, and adverse events were comparable between arms when adjusted for exposure to nab-paclitaxel. This reinforces the concept that relacorilant is modulating tumor biology, not simply adding toxicity.

One of the most clinically relevant aspects of this approval is its lack of biomarker dependence, Dr. Dana Chase, Program Director at the Division of Gynecologic Oncology Department at UCLA, tells SurvivorNet Connect.

“This is a treatment that does not rely on a biomarker, meaning more patients can have access to it,” Dr. Chase adds.

In an era increasingly defined by molecular stratification, the ability to offer an effective therapy without requiring BRCA, HRD, or PD-L1 testing simplifies decision-making and expands access, particularly in community settings. Clinicians are now navigating a more complex, but more promising therapeutic landscape.

A Subtle But Important Shift in Sequencing

Dr. Chase adds that the approval provides a much-needed non-antibody drug conjugate (ADC) option for recurrent ovarian cancer.

“ADCs are becoming incorporated into frontline trials, which means we will have limited ability to use these for recurrent cases. So, having a non-ADC option for recurrent ovarian cancer that does not require a biomarker is meaningful,” Dr. Chase explains.

As ADCs move earlier in the treatment paradigm, their availability in later lines may become constrained. In that context, relacorilant offers a mechanistically distinct option that preserves sequencing flexibility.

This consideration (how to “save” effective therapies for later lines) is becoming increasingly important as the number of active agents grows.

Though having an additional option for PROC patients is practice-changing in the sense that it adds another tool that may be the right choice for certain patients, the newest FDA approval is not likely to displace existing standards.

“Now, patients and physicians have clinically active regimens and can tailor the side effect profiles for patients, too,” Dr. Thaker says.

Dr. Rodrigo C. Leão Edelmuth is a board certified digestive surgeon at Hospital Israelita Albert Einstein in São Paulo, Brazil. He holds his General Surgery and Digestive Surgery degree from São Paulo University Medical School.

He underwent a postgraduate course on Surgical Leadership at Harvard Medical School and a Research Fellowship in the Department of Surgery at Weill Cornell Medicine in New York. Dr. Edelmuth is member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and of the Society for Surgery of the Alimentary Tract (SSAT). In 2022 he received the SAGES Career Development Award.

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