Ovarian Cancer

The FDA has removed the partial clinical hold on the phase 2 LINNET study of lorigerlimab for patients with platinum-resistant ovarian cancer and clear cell gynecologic cancer.

The FDA granted fast track designation to SIM0505, a CDH6-directed antibody-drug conjugate, for the management of platinum-resistant ovarian cancer.

Robert Coleman, MD, FACOG, FACS, discusses the significance of the relacorilant and nab-paclitaxel approval in PROC supported by phase 3 ROSELLA trial data.

The FDA granted FTD to CTIM-76, a CLDN6/CD3 bispecific antibody, for the treatment of patients with CLDN6-positive platinum-resistant ovarian cancer.

ZW191 is currently under evaluation in a phase 1 trial that has already demonstrated activity among patients with platinum-resistant ovarian cancer.

Updated data demonstrated a 14.7-month OS benefit when adding IMNN-001 to neoadjuvant chemotherapy in patients with newly diagnosed ovarian cancer.

Data from the ROSELLA trial support the approval of relacorilant plus nab-paclitaxel in this ovarian cancer population.

The MyChoice CDx was approved based on its performance determining HRD status and stratifying patients in the phase 3 PRIMA trial.

Updated results from the phase 3 KEYNOTE-B96 trial revealed that pembrolizumab plus paclitaxel with or without bevacizumab improved OS in all comers.

Relacorilant plus nab-paclitaxel improved PFS among patients with PROC who had progression after a PARP inhibitor or who were 65 years or older.

A partial clinical hold has been placed on the phase 2 LINNET trial following the report of several serious safety events, including 1 treatment-related death.

Treatment with relacorilant plus nab-paclitaxel yielded a 35% reduction in the risk of death compared with nab-paclitaxel alone for patients with platinum-resistant ovarian cancer.

Maveropepimut-S with pembrolizumab and low-dose cyclophosphamide yielded a 40% ORR and 90% DCR in platinum-sensitive high-grade endometrial cancer.

The folate receptor α ADC yielded responses, with a favorable safety profile, in patients with high-grade serous ovarian cancer in a phase 1 trial.

No grade 3 or greater treatment-related adverse effects or long-term safety signals emerged with gemogenovatucel-T in this ovarian cancer group.

The safety profile of atezolizumab plus bevacizumab and chemotherapy in this phase 3 trial was comparable with prior reports of the agents.

BI-1808 plus pembrolizumab was safe and well-tolerated among patients with recurrent ovarian cancer.

Among 35 patients with ovarian cancer treated with an antibody-based combination, the overall response rate was 23%, with a clinical benefit rate of 31%.

Pooled analysis data from the phase 1 JSKN003-101 and phase 1/2 JSKN003-102 trials support the regulatory decision.

Fuzuloparib monotherapy and as a combination with apatinib improved PFS as maintenance therapy in patients with ovarian cancer harboring BRCA1/2 mutations.

Although both immune priming strategies numerically improved ORR and PFS vs olaparib monotherapy, the study was not powered for comparisons between arms.

The median PFS for patients with ovarian cancer who received niraparib maintenance in the real-world setting was 25.7 months.

Although the study was underpowered due to a small sample size, nonsignificant improvements in functional and social well-being occurred with MOST-S26.

Phase 3 data demonstrate PD-L1 positivity and BRCA mutation status as prognostic for improved overall survival regardless of treatment arm.

The FDA decision is based on data from a pooled analysis of phase 1/2 study data from 2 trials evaluating the agent in advanced/metastatic PROC.