Arizona Oncology (Honor Health Systems), University of Arizona College Of Medicine, Creighton University School of Medicine at St. Joseph’s Hospital
Division of Gynecologic Oncology
Dr. Bradley Monk graduated at the top of his class from the University of Arizona College of Medicine-Tucson in 1988, and completed a residency in Obstetrics and Gynecology at the University of California, Los Angeles, in 1992. Between 1988 and 1995, he was the recipient of three fellowships in Medical Genetics and Gynecologic Oncology. In 1995, Dr. Monk was appointed Director of Gynecologic Oncology at Texas Tech University Health Services Center and, from 1998 until 2010, was Associate Professor with Tenure of the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology at the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center and Director of Research in the Department of Obstetrics and Gynecology. Dr. Monk was then appointed Director and Professor in the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center in Phoenix, AZ. In 2016, he became a member of Arizona Oncology and part of the US Oncology Network and continues to practice in Phoenix. Most recently, he has been appointed the US Oncology Medical Director of Gynecologic Oncology Research. Dr. Monk is also a Professor on the Clinical Scholar Track at the University of Arizona College of Medicine – Phoenix and works at Arizona Oncology (US Oncology Network). Dr. Monk’s research interests include the prevention and treatment of gynecologic cancers. He was the first to report the activity of anti-vascular growth factor (VEGF) therapy in ovarian cancer and his papers in the New England Journal of Medicine led to the global approval of anti-VEGF therapy in recurrent cervical cancer in 2014 and advanced ovarian in 2018. He was also the lead author on the pivotal trial of trabectedin in recurrent ovarian cancer as well as many other studies that have met their primary endpoints. Finally, his other papers in the New England Journal of Medicine and Lancet Oncology have led to four FDA approvals of PARP inhibitors is ovarian cancer. Dr. Monk was also awarded the highly prestigious Ernst Wertheim Award for his research in cervical cancer and is on the Board of Directors for the GOG Foundation, Inc. and was the Cervical Cancer Sub-Committee Chair for NRG Oncology for 11 years. He currently chairs the Cervical Cancer Committee for the Gynecologic Cancer Intergroup (GCIG). Finally, he is Vice President and on the Board of Directors for the GOG Foundation and Co-directs the GOG Partners Research consortium as well as being the lead investigator (Director) of gynecologic cancers in the US Oncology Network (USON). Dr. Monk is a fellow of the American College of Surgeons, the American College of Obstetricians and Gynecologists) and the American Society for Colposcopy and Cervical Pathology, as well as being an active member of the Society of Gynecologic Oncology, International Gynecologic Cancer Society and American Society of Clinical Oncology. He has authored more than 360 peer-reviewed articles along with more than 30 book chapters dealing predominantly with the prevention and chemotherapy of gynecologic malignancies and patient quality of life.

Moderator of 2 Sessions

Session Type
Master Session
Date
10/01/2022
Session Time
10:05 AM - 12:05 PM
Room
Hall 501
Session Icon
Live
Session Description
The session will focus on the state of the art of HPV vaccination in cervical cancer prevention programs.Attendees will be informed about the controversies about the surgical treatment in cervical cancer.Resource-based radiotherapy treatment standard will be provided.Latest news in immunotherapy and new agents in the treatment of cervical cancer will be discussed.A deeper focus on molecular and pathologic characteristics of cervical cancer will be discussed.
Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 501
Session Description
A Clinical Case Symposium: PARP Inhibitors in Advanced Ovarian Cancer and the Impact on Survival - Industry Symposium by Medscape

Session Description:

Supporter Statement:Supported by an independent educational grant from AstraZeneca Pharmaceuticals LP; Merck & Co., Inc; GlaxoSmithKline

Partner Statement:Developed through a collaboration between The GOG Foundation, Inc. and Medscape Oncology

This 90-minute lunch symposium will feature expert faculty guiding clinicians through patient case challenges focusing on areas of controversy in advanced ovarian cancer. The patient case challenges will allow for extensive audience engagement, and faculty will provide clinical guidance and feedback at key decision points. Please come with your most pressing questions.

Presenter of 13 Presentations

Concluding remarks

Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 501
Lecture Time
02:00 PM - 02:05 PM

Defining platinum base therapy that is no longer an option for patients

Session Type
Industry Symposia
Date
09/29/2022
Session Time
11:55 AM - 01:25 PM
Room
Hall 405
Lecture Time
12:00 PM - 12:15 PM

Q&A/Discussion

Session Type
Master Session
Date
10/01/2022
Session Time
10:05 AM - 12:05 PM
Room
Hall 501
Session Icon
Live
Lecture Time
11:50 AM - 12:00 PM
Onsite or Pre-Recorded
Onsite

Welcome and Introduction

Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 501
Lecture Time
12:35 PM - 12:40 PM

• Potential impact on standard of care: Review of pending trials - Analysis

Session Type
Master Session
Date
09/30/2022
Session Time
04:00 PM - 06:25 PM
Room
Hall 501
Session Icon
Live
Lecture Time
04:42 PM - 04:54 PM
Onsite or Pre-Recorded
Onsite

Panel Discussion and Audience Q&A

Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 501
Lecture Time
01:45 PM - 02:00 PM

Q&A/Discussion

Session Type
Master Session
Date
10/01/2022
Session Time
10:05 AM - 12:05 PM
Room
Hall 501
Session Icon
Live
Lecture Time
10:55 AM - 11:05 AM
Onsite or Pre-Recorded
Onsite

Group Discussion: Impact of PARP Inhibitors on subsequent therapies

Closing Comments

Session Type
Master Session
Date
10/01/2022
Session Time
10:05 AM - 12:05 PM
Room
Hall 501
Session Icon
Live
Lecture Time
12:00 PM - 12:05 PM
Onsite or Pre-Recorded
Onsite

Consensus or Controversy? Endpoints in Trials of PARP Inhibitors in Advanced Ovarian Cancer

Session Type
Industry Symposia
Date
10/01/2022
Session Time
12:35 PM - 02:05 PM
Room
Hall 501
Lecture Time
12:40 PM - 12:55 PM

DURVALUMAB, IN COMBINATION WITH AND FOLLOWING CHEMORADIOTHERAPY, IN LOCALLY ADVANCED CERVICAL CANCER: RESULTS FROM THE PHASE 3 INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CALLA TRIAL

Session Type
Plenary Session
Date
09/29/2022
Session Time
08:00 AM - 10:30 AM
Room
Hall 501
Session Icon
Live
Lecture Time
08:10 AM - 08:18 AM
Onsite or Pre-Recorded
Onsite

Abstract

Objectives

In locally-advanced cervical cancer (LACC), platinum-based chemoradiotherapy (CRT) has been the standard- of-care treatment for >20 years. CALLA is the first global Phase 3 study evaluating immune checkpoint inhibition (durvalumab) versus placebo in combination with and following CRT in LACC (NCT03830866).

Methods

Newly-diagnosed, untreated patients with LACC (FIGO 2009 stages IB2–IIB node positive, IIIA–IVA with any node status) were randomized 1:1 to durvalumab (1500 mg IV) or placebo Q4W, for a total of up to 24 months, in combination with and following CRT. CRT comprised concurrent weekly IV cisplatin with EBRT and brachytherapy. RT quality was monitored, with variations evaluated for clinical significance. The primary endpoint is PFS; secondary endpoints include OS, objective response rate, local/distant disease progression incidence, and safety.

Results

770 patients were randomized (N=385 per arm) at 120 sites in 15 countries. Median age was 49 years; median follow-up was 18.5 months.

Durvalumab+CRT did not show a statistically significant improvement in PFS vs placebo+CRT (HR 0.84 [95% CI, 0.65-1.08]; P=0.174); there was no detriment to OS, although data were immature and not formally tested.

Adverse events of grade 3–4 occurred in 51.7% and 51.0% of patients in the durvalumab+CRT and placebo+CRT arms, respectively; 12.5% and 9.6% of patients discontinued treatment due to AEs possibly related to study drug.

Conclusions

Durvalumab in combination with and following CRT did not significantly improve PFS in patients with LACC. Safety of durvalumab+CRT was generally comparable to CRT alone, with no new or unexpected toxicity.

Funding: AstraZeneca

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SEMINAL ABSTRACT PRESENTATION: ATHENA–MONO (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL EVALUATING RUCAPARIB MONOTHERAPY VS PLACEBO AS MAINTENANCE TREATMENT FOLLOWING RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IN OVARIAN CANCER

Session Type
Plenary Session
Date
09/30/2022
Session Time
02:45 PM - 03:55 PM
Room
Hall 501
Session Icon
Live
Lecture Time
02:48 PM - 02:53 PM
Onsite or Pre-Recorded
Onsite

Abstract

Objectives

While PARP inhibitors have shown efficacy as first-line (1L) maintenance treatment for patients (pts) with ovarian cancer (OC), questions remain about the pt population that may benefit from their use. ATHENA (NCT03522246) was designed to test if rucaparib may be effective as 1L maintenance treatment in a broad pt population, including those without BRCA mutations or other evidence of homologous recombination deficiency (HRD), or high-risk clinical characteristics such as residual disease. Here we report results from the ATHENA–MONO comparison of rucaparib vs placebo.

Methods

Pts with stage III–IV high-grade OC who had completed cytoreductive surgery (R0 permitted) and 4–8 cycles of 1L platinum-doublet (bevacizumab allowed with chemotherapy) with a response were randomized 4:1 to oral rucaparib 600 mg BID or placebo. Pts were stratified by HRD status (as determined by FoundationOne CDx), residual disease status after chemotherapy, and timing of surgery. The primary endpoint of investigator-assessed PFS per RECIST was assessed in a step-down procedure first in the HRD population (BRCA mutant or BRCA wild-type/loss of heterozygosity [LOH] high carcinoma) and then in the intent-to-treat (ITT) population. Blinded independent central review (BICR)–assessed PFS was a stand-alone, secondary endpoint. PFS in BRCA mutant and HRD-negative pts (BRCA wild-type/LOH low) were exploratory endpoints.

Results

As of Mar 23, 2022 (visit cutoff), 427 and 111 pts were randomized to rucaparib monotherapy or placebo (median time on treatment, 14.7 and 9.9 mo). PFS data are shown in the Table. Most common grade ≥3 TEAEs were anemia (rucaparib, 28.7% vs placebo, 0%), neutropenia (14.6% vs 0.9%), and ALT/AST increased (10.6% vs 0.9%). Rucaparib dose reduction, interruption, and discontinuation due to TEAEs occurred in 49.4%, 60.7%, and 11.8% of pts.

Conclusions

Rucaparib monotherapy is effective as 1L maintenance with significant benefit vs placebo observed in the ITT and HRD populations, as well as the non-nested subgroup of pts without known HRD.
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