Abstract 285O
Background
Homologous recombination deficiency (HRD) prevalence and utilization of different HRD testing kits are not well-characterized across geographies. The HALO study (NCT04991051) determined the prevalence of HRD in patients (pts) with high-grade serous or endometrioid ovarian cancer (HGSOC/HGEOC), primary peritoneal cancer (PPC), and/or fallopian tube cancer (FTC) across Asia, Middle East and Africa (MEA) and Russia.
Methods
This cross-sectional multinational study enrolled consenting adult women with newly diagnosed stage III or IV (FIGO 2014) HGSOC or HGEOC, PPC and/or FTC having formalin-fixed paraffin tumour blocks collected within 120 days of enrolment. We present the prevalence of HRD with genomic instability (GI) excluding tumour BRCA1/2 mutation (tBRCA1/2m) and tBRCA1/2m only using next-generation sequencing (NGS).
Results
Overall, 734 pts (median age, 59.0 [range 23.0, 89.0] yrs) recruited between May-21 and Oct-22 across Asia (n=76), MEA (n=195) and Russia (n=463) were analysed. Majority (88.1%) never smoked, had attained menopause (83.9%) and were multiparous (78.8%). 34.1% had family history of cancer. Most (92.9%) had primary tumour in the ovaries, followed by PPC (4.1%) and FTC (3.0%). HRD status was analysed in 662 pts; of whom 56.0% (371) were HRD positive— 30.8% (204) had GI high score excluding tBRCA1/2m, and 25.2% (167) had tBRCA1/2m. HRD prevalence in Asia, MEA and Russia were 52.0%, 52.2% and 58.5%, respectively. Commercial kits were frequently used for HRD testing (374, 56.5%); predominantly Amoydx (329, 88.0%). Table: 285O
Prevalence of HRD
HRD status, n, % | Overall, N=662 | Asia, N=75 | MEA, N=180 | Russia, N=407 |
Positive | 371, 56.0 | 39, 52.0 | 94, 52.2 | 238, 58.5 |
GI excluding tBRCA1/2m | 204, 30.8 | 31, 41.3 | 43, 23.9 | 130, 31.9 |
tBRCA1/2m only | 167, 25.2 | 08, 10.7 | 51, 28.3 | 108, 26.5 |
Negative | 287, 43.4 | 33, 44.0 | 85, 47.2 | 169, 41.5 |
Unknown | 04, 0.6 | 03, 4.0 | 01, 0.6 | 0 |
Test kits, n, % | ||||
Commercial | 374, 56.5 | 0 | 107, 59.4 | 267, 65.6 |
Lab-developed | 138, 20.8 | 69, 92.0 | 69, 38.3 | 0 |
Myriad myChoice® HRD | 120, 18.1 | 06, 8.0 | 02, 1.1 | 112, 27.5 |
Other | 30, 4.5 | 0 | 02, 1.1 | 28, 6.9 |
HRD positivity: deleterious/suspected pathogenic tBRCA1/2m and/or GI positive (per reference laboratory of each country and NGS-based in vitro diagnostic test).
Conclusions
This pioneering real-world study reports HRD prevalence in a large cohort of pts, ranging from 52.0% - 58.5% across the three study regions. Our results highlight the unmet need for capturing biomarker testing data and the utility of different HRD testing kits in real-world in resource-limited settings to inform treatment decisions.
Clinical trial identification
NCT04991051.
Editorial acknowledgement
This study was funded by AstraZeneca. As per the GPP3 guidelines, the authors would like to thank Dr. Soma Santra of Fortrea Scietific Pvt. Ltd, for medical writing support.
Legal entity responsible for the study
AstraZeneca International.
Funding
AstraZeneca International.
Disclosure
A. Tyulyandina: Financial Interests, Personal, Advisory Board, AstraZeneca, Advisory Board, Personal Biocad, Advisory Board, Personal Eisai, Invited Speaker, Personal MSD, Advisory Board, Personal Pfizer, Expert Testimony, Personal Roche, Invited Speaker, Personal Non-Financial Interests AstraZeneca, Principal Investigator Biocad, Principal Investigator MSD, Advisory Role MSD, Principal Investigator Roche, Principal Investigator: AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
286MO - Efficacy of low dose nivolumab in recurrent / metastatic cervical cancer
Presenter: Sowmica Devabhaktuni
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast
287MO - Real-world experience with maintenance PARP inhibitor plus minus bevacizumab in newly diagnosed advanced ovarian cancer with germline BRCA mutations or homologous recombination deficiency (HRD) positive
Presenter: Somnath Roy
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast
Invited Discussant 285O, 286MO and 287MO
Presenter: Smruti Koppikar
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Slides
Webcast
Q&A and discussion
Presenter: All Speakers
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Webcast
288MO - InnovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer
Presenter: Keiichi Fujiwara
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast
289MO - Fruquintinib plus sintilimab in advanced cervical cancer (CC) patients (pts): Results from a multicenter, single-arm phase II study
Presenter: Xiaotian Han
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast
290MO - Efficacy and safety of topical sintilimab administration in conjunction with CRT and Californium-252 neutron brachytherapy in first-line advanced gynecological squamous cell carcinoma patients
Presenter: Xiaoling Li
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast
Invited Discussant 288MO, 289MO and 290MO
Presenter: Alexandra Leary
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Slides
Webcast
Q&A and discussion
Presenter: All Speakers
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Webcast
LBA8 - Preliminary efficacy of pembrolizumab plus lenvatinib (PL) in recurrent clear cell gynecological cancer (CCGC): Phase II LARA trial (GCGS-OV4/ APGOT-OV3)
Presenter: Natalie Ngoi
Session: Mixed Proffered paper and Mini oral session: Gynaecological cancers
Resources:
Abstract
Slides
Webcast