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ROSELLA — Relacorilant + nab-paclitaxel in platinum-resistant ovarian cancer (post-bevacizumab)

Abstract: LBA, Plenary I · Session: Plenary I, Friday April 10, 2026 (opening session, San Juan Convention Center) · Simultaneous publication: The Lancet 2026 Apr 10 — DOI:10.1016/S0140-6736(26)00462-9

Headline: Phase 3 OS win with mOS 16.0 vs 11.9 mo (HR 0.65, p=0.0004) — the first GR-antagonist Phase 3 victory in solid tumor and the cycle-defining readout of SGO 2026; Corcept's Lifyorli (relacorilant) was already FDA-approved March 2026, making this the simultaneous Lancet victory-lap.

At a glance

  • Sponsor / cooperative groups: Corcept Therapeutics · GOG-3073 / ENGOT-ov72 / APGOT-Ov10 / LACOG-0223 / ANZGOG-2221 (five-group multi-region design)
  • PI / presenter: Plenary I LBA, Apr 10 (presenter TBD per SGO program)
  • NCT ID: NCT05257408
  • Phase / arms / N: Phase 3, 2-arm randomized open-label; ~381 enrolled (intermittent relacorilant + nab-paclitaxel vs nab-paclitaxel monotherapy)
  • Primary endpoint(s): OS and PFS (dual primary)
  • Indication / line: Platinum-resistant epithelial ovarian, fallopian tube, primary peritoneal cancer, post-bevacizumab
  • Comparator: Nab-paclitaxel monotherapy
  • Session: Plenary I (Day 1, Apr 10)

Headline result

mOS 16.0 vs 11.9 mo (HR 0.65, 95% CI 0.51–0.83, p=0.0004) — a 4.1-mo absolute survival gain in a setting where mOS has stagnated at ~12 mo for a decade. mPFS HR 0.70 (p=0.0076). Benefit was consistent across pre-specified subgroups including prior bevacizumab exposure and number of prior lines. Simultaneous Lancet publication day-of-presentation.

Mechanism / class

Relacorilant is a selective glucocorticoid receptor (GR) antagonist — first-in-class oral non-steroidal modulator that blocks cortisol-mediated chemotherapy resistance without affecting the progesterone receptor. ROSELLA is the first Phase 3 win for the GR-antagonist class in any solid tumor.

Trial design deep dive

Study architecture: Phase 3 randomized open-label, 1:1 to intermittent relacorilant (150 mg PO day prior, day of, day after nab-paclitaxel) + nab-paclitaxel vs nab-paclitaxel monotherapy. ~381 patients across GOG-3073 / ENGOT-ov72 / APGOT-Ov10 / LACOG-0223 / ANZGOG-2221 — a five-cooperative-group, multi-region footprint spanning North America, Europe, Asia-Pacific, and Latin America. Stratification factors TBD per protocol; prior bevacizumab exposure was an enrollment requirement, narrowing the population to the post-bev PROC setting where therapeutic options collapse fastest.

Endpoint definitions: Dual primary OS and PFS — an aggressive design choice that requires both endpoints to win or fall under a pre-specified alpha-spending plan (specifics TBD). PFS by investigator assessment per RECIST 1.1; OS by event-driven analysis. Key secondary endpoints include ORR, DOR, PRO/QoL (FACT-O), and safety.

Key subgroup analyses: Headline benefit consistent across prior bevacizumab exposure (a mandated enrollment criterion, so the subgroup is largely homogeneous) and number of prior lines of therapy. HRD/BRCA, age, ECOG, and geographic-region subgroup forest plots reserved for ASCO 2026 follow-up per the cross-link plan. Intermittent vs continuous GR-antagonist dosing schedule was an important Phase 2 design question that this Phase 3 inherited.

Comparator context: Nab-paclitaxel monotherapy is an accepted PROC reference (mOS ~11–12 mo historically), but the field has drifted toward MIRV (FRα+) and mirvetuximab combinations. The 11.9-mo control arm here is consistent with that benchmark, validating the comparator choice.

FDA implications: Approval pre-dated the readout (Lifyorli March 2026) on PFS interim plus OS trend; the Plenary I full OS readout locks in the label and underwrites EMA H2 2026 submission. NCCN incorporation already in motion.

Discussant takeaway

Plenary I framing reframed platinum-resistant ovarian as a setting where mechanism diversity (GR antagonism alongside ADCs and pembro combinations) is now generating real OS gains — the decade-long stagnation broke in early 2026.

Practice-changing verdict

Yes — already practice-changing pre-presentation. Lifyorli (relacorilant) FDA approval came March 2026, one month ahead of SGO. The Lancet publication and Plenary I slot anchored rapid NCCN-guideline incorporation. Cross-tumor GR-antagonist read-through expected in breast and prostate.

  • AACR 2026: GR-antagonism mechanism sessions one week after SGO (Apr 17–22)
  • ASCO 2026: Expected ROSELLA subgroup analyses (HRD, BRCA, prior bev exposure, line of therapy) + PRO/QoL secondary endpoints
  • JPM 2026: Corcept ($CORT) framed Lifyorli FDA submission at JPM Jan 12–15
  • ESMO 2026: EMA decision likely H2 2026

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