Clinica Universidad di Navarra
Medical Oncology
Antonio González-Martín graduated in medicine at the University of Navarra in Pamplona (Spain) and subsequently trained in medical oncology at University Hospital Ramón y Cajal in Madrid (Spain) from 1994 to 1997. During part of 1997, he attended as an observer to The Mount Sinai School of Medicine in New York. Since September 2017 he joined Clínica Universidad de Navarra in Madrid as head of Medical Oncology Department, and was appointed Director of Cancer Centre Universidad de Navarra in 2020. He is an Associate Professor at Medicine at Francisco de Vitoria University in Madrid (Spain) and collaborator Professor at Universidad de Navarra. He got the PhD degree at Francisco de Vitoria University in April 2018. He is the chairman of GEICO (Spanish group for investigation in ovarian and gynaecological cancer) and was the President in ENGOT (European Network for Gynaecological Oncological Trials), for the period 2018-2020. In addition, he is one of the delegates in Gynaecologic Cancer InterGroup (GCIG), and has served as chair of the ovarian cancer committee for the period 2014-2020. He has several relevant publications in the field of gynaecological. He is considered an expert in gynaecological cancer and has lectured widely on these areas of interest.

Presenter of 3 Presentations

Antibody-Drug Conjugates (ADCs) and Ongoing Clinical Trials

Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 405
Lecture Time
01:40 PM - 02:00 PM

SEMINAL ABSTRACT PRESENTATION: PRIMA/ENGOT-OV26/GOG-3012 STUDY: UPDATED LONG-TERM PFS AND SAFETY

Session Type
Plenary Session
Date
09/30/2022
Session Time
02:45 PM - 03:55 PM
Room
Hall 501
Session Icon
Live
Lecture Time
03:08 PM - 03:13 PM
Onsite or Pre-Recorded
Onsite

Abstract

Objectives

Niraparib (nir) has shown PFS benefit as a first-line (1L) maintenance therapy (MT) in the primary analysis of PRIMA (data cut 17 May 2019) in all subgroups regardless of biomarker status. These results were the basis for approval of nir as MT after response to 1L platinum-based chemo (CT). Here we report updated long-term efficacy and safety in the PRIMA study.

Methods

This double-blind, placebo (PBO)-controlled phase 3 trial evaluated nir in pts with newly diagnosed advanced high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (OC) with a complete or partial response (CR or PR) to 1L platinum-based CT. Stratification factors were best response to 1L CT regimen (CR/PR), receipt of neoadjuvant CT (NACT; yes/no), and homologous recombination deficiency (HRD) status (HRd/HRp/HRnd) per Myriad myChoice HRD test. Pts received nir or PBO QD (2:1 ratio). The primary endpoint of PFS by blinded independent central review was concordant with investigator assessment (INV). Updated (ad hoc) data are by INV, as of 17 Nov 2021.

Results

Of 733 randomized pts (nir, 487; PBO, 246), 373 (51%) were HRd (nir, 247; PBO, 126), and 249 (34%) were HRp (nir, 169; PBO, 80). Overall, 35% had stage IV disease, 67% received NACT, and 33% had a PR to 1L CT. As of 17 Nov 2021, median PFS follow-up time was 3.5 y. Nir-treated pts (HRd/HRp/overall) received continued PFS benefit vs PBO (Table). All subgroups showed a sustained and durable treatment effect. The most common grade ≥3 adverse events in the nir arm were thrombocytopenia (40%), anemia (32%), and neutropenia (21%). No related ontreatment deaths occurred. MDS/AML were reported at the same incidence in nir 6/484 (1.2%) and PBO 3/244 (1.2%) arms. OS remains immature at 41% for the overall population; 33% of PBO vs 9% of nir pts received subsequent PARPi.
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Conclusions

Nir maintained clinically significant improvement in PFS with 3.5 y of follow-up in pts with newly diagnosed advanced OC at high risk of progression irrespective of HRD status. No new safety signals were identified.

Clinical Trial Identifier: NCT02655016
Funding This study (NCT02655016) was sponsored by GlaxoSmithKline, Waltham, MA, USA.
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