Table 1

Summary of clinical trials on developmental therapeutics

Abstract IDAbstract typeStudy designStudy name and/or IDTarget or biomarkerInterventionPreliminary results
Abstracts presented at ASCO23
LBA55075Oral abstract sessionPhase IIIMIRASOL; GOG 3045/ENGOT-ov55; NCT04209855FR-αMirvetuximab soravtansine vs investigator’s choice of chemotherapyThis antibody–drug conjugate improved progression-free survival and overall survival in platinum-resistant ovarian cancer compared with single agents (paclitaxel, pegylated liposomal doxorubicin, or topotecan)
55057Oral abstract sessionPhase IIIOVAL Study/GOG 3018; NCT03398655FasR/ TNFR1Ofranergene obadenovec combined with paclitaxel vs paclitaxel with placeboThe combination of ofranergene obadenovec to paclitaxel did not improve progression-free survival or overall survival
TPS56128Poster sessionPhase III (study protocol)ARTISTRY-7; GOG-3063; ENGOT-OV68; NCT05092360CD8+ T cells and natural killersNemvaleukin and/or pembrolizumab vs chemotherapy
  • The study will randomize 376 patients to receive nemvaleukin α as a combination therapy with pembrolizumab compared with investigator’s choice chemotherapy

  • This trial is currently recruiting patients, and it has an estimated primary completion date in December 2025

55089Oral abstract sessionPhase ISTRO-002-GM1; NCT03748186FR-αLuveltamab tazevibulin
  • Progression-free survival and objective response rate in RECIST-evaluable patients of this dose expansion cohort (FolRα intensity expression >25%) were 6.1 months and 37.5%, respectively

  • Emerging treatment adverse events led to dose reduction in 61% of enrolled patients

  • Most common grade ≥3 adverse events were neutropenia (70.5%), arthralgia (18.2%), and anemia (13.6%)

e1755210Publication onlyPhase IICC-ANNIE; NCT05130515PARP/
VEGFR
Niraparib and anlotinib combination
  • This study did not meet the primary efficacy endpoint

  • This combination did not show activity in patients with platinum-resistant clear cell histotype

551211Poster sessionPhase IINCI-9944; NCT02595892ATRBerzosertib and gemcitabine vs gemcitabine
  • Combination of gemcitabine/berzosertib did not significantly improve overall survival vs gemcitabine alone

  • Overall survival benefits were observed in patients harboring low replication stress alterations

557412Poster sessionPhase INCT03246074SykFostamatinib combined with weekly paclitaxelThis combination showed signals of efficacy including partial and complete responses (39%)
554413Poster sessionPhase INCT04406623CD47SL-172154 (SIRPα-Fc-CD40L)This first-in-human drug was well tolerated, and best reported response was stable disease in 6 of 27 evaluable patients
559014Poster sessionPhase INCT03907527PRGN-3005 autologous UltraCAR-TThis CART cell-based therapy was well tolerated and provided encouraging disease control rates
TPS561715Poster sessionPhase II (study protocol)NCT04918186CRI-CCTG-0003/
IND.240 immunotherapy platform (IPROC)
  • This adaptive platform trial was designed to evaluate various combinations of immune-checkpoint inhibitors and antibody-drug conjugates accommodated by both biomarker-agnostic and biomarker-directed selection

  • The estimated primary completion date of this trial is June 2024, and it is currently recruiting platinum-resistant ovarian cancer patients

TPS561616Poster sessionPhase I/II (study protocol)NCT05538624IL-2AVB-001
  • This first-in-human study investigating this encapsulated cell product engineered to produce native human interleukin-2 to be delivered intraperitoneally is currently recruiting patients

  • It is expected to enroll 44* platinum-resistant ovarian cancer patients and it is estimated to be completed in August 2026

301217Poster sessionPhase IDebio 0123–101; NCT03968653WEE1Debio 0123This ATP-competitive WEE1 inhibitor combined with carboplatin was well tolerated and it was found to be effective with confirmed partial responses in 4 of 12 evaluable PROC patients
555418Poster sessionPhase INCT04329494Pressurized intraperitoneal aerosolized chemotherapy (PIPAC)
  • PIPAC using cisplatin/doxorubicin in platinum-resistant ovarian cancer showed intraperitoneal responses in patients with low-grade serous carcinoma patients

  • Heavily pretreated and high grade platinum-resistant ovarian cancer derived limited intraperitoneal control

Abstracts presented at ESMO23
747O19Oral abstract sessionPhase IIBOUQUET; NCT04931342MEK1/
PD-L1-VEGF
Cobimetinib or atezolizumab
+bevacizumab
Patients who received ≥3 prior lines of treatment had a 16% confirmed objective response rate with cobimetinib and 14% with the combination
753P20Poster sessionPhase IbNCT05551507FAKIN10018+pegylated liposomal doxorubicin
  • No grade 4 or 5 adverse events related to IN10018 were reported

  • Objective response rate was 46.3%, median progression-free survival was 7.3 months and median overall survival was 20.9 months in all treated patient populations

746MO21Oral abstract sessionPhase IINCT04739800;
NRG-GY023
PARP-VEGFR
-PD-L1
Durvalumab+olaparib+ cediranib/
olaparib+cediranib/
durvalumab+cediranib/
standard of care chemotherapy
None of the experimental combinations improved progression-free survival compared with chemotherapy in heavily pretreated platinum-resistant ovarian cancer
745MO22Oral abstract sessionPhase INCT04707248Cadherin 6Raludotatug deruxtecanAdverse events of grade ≥3 were observed in 50% of the study population, and 38% of the enrolled patients exhibited a response, including one complete response
  • *Based on clinical trial record on clinicaltrials.gov database.

  • ATR, ataxia telangiectasia and Rad3-related protein; CART, chimeric antigen receptor T cells; FAK, focal adhesion kinase; FR-α, folate receptor α; IL, interleukin; IPROC, Immunotherapy platform study in platinum-resistant high grade serous ovarian cancer; PARP, poly-ADP ribose polymerase; PD-L1, programmed cell death ligand 1; PIPAC, pressurized intraperitoneal aerosolized chemotherapy; PROC, platinum-resistant ovarian cancer; RECIST, Response Evaluation Criteria in Solid Tumors; TNFR1, tumor necrosis factor receptor 1; VEGF, vascular endothelial growth factor.