Advertisement


Bradley J. Monk, MD, on Ovarian Cancer: New Data on Rucaparib Monotherapy vs Placebo as Maintenance Treatment

2022 ASCO Annual Meeting

Advertisement

Bradley J. Monk, MD, of the University of Arizona College of Medicine and Creighton University School of Medicine, discusses phase III findings from the ATHENA–MONO (GOG-3020/ENGOT-ov45) trial. It showed that rucaparib as first-line maintenance treatment, following first-line platinum-based chemotherapy, improved progression-free survival in patients with ovarian cancer, irrespective of homologous recombination deficiency status (Abstract LBA5500).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
ATHENA-MONO was a randomized Phase 3 trial looking at rucaparib versus placebo in frontline maintenance after responding to platinum-based therapy. Now you may say, "We already use that." There was another study, which I'm very proud of, called PRIMA that I was the last author on. That study is very helpful and gained FDA approval as you know in April 2020, but this adds confidence to that. In fact, the ASCO guidelines say that all patients with newly diagnosed advanced ovarian cancer who respond to a platinum-based therapy should be considered for a PARP inhibitor. So hopefully if you're not doing it, you'll begin, that ATHENA-MONO will add confidence to it. Now, the medication that we studied was rucaparib. Rucaparib is a PARP inhibitor. It has four doses, 600, 500, 400, 300. The primary endpoint was in patients who had a molecular signature consistent with homologous recombination according to the FoundationOne CDx. When we randomized patients, and they're randomized 4:1, 528 patients in 24 countries in more than 200 sites, we reached our primary endpoint. Think of this. The hazard ratio versus placebo in the rucaparib patients, according to the HRD biomarker, which is about half of the patients based on the investigator, was 28.7 months. Think of that. Newly diagnosed advanced ovarian cancer, stage three and four that respond to platinum-based therapy now can live more than two years versus placebo where they live less than a year, 11.3 months. Based on a step-down analysis, we pivoted to an intent-to-treat analysis and it was still double: placebo, 9.2 months, the rucaparib arm, 20.2 months, hazard ratio of 0.52. Even in the biomarker negative subgroup there was still a statistically significant and clinically relevant impact in progression-free survival. Now that comes with a cost. About half of the patients required a dose reduction after an interruption, but the quality of life was maintained, and because of the dosing flexibility, again, 600, 500, 400, 300 twice daily, more than 70% of the patients could be maintained on 80% of the dose, which was 500 or 600. What's next? Next is ATHENA-COMBO. So in this ATHENA-MONO arm, the rucaparib was the experimental arm, but in ATHENA-COMBO, which is a fully powered independent but related study, now the rucaparib is the control arm. The experimental arm now randomized 1:1, 400 patients in each arm, will be rucaparib/nivolumab. You recall that JAVELIN 100 was negative adding avelumab to frontline chemotherapy. You'll recall that IMAGINE 50 was negative adding atezolizumab to bevacizumab, but now this is maintenance in PARP plus IO. So stay tuned. We hope to have the results to ATHENA-COMBO potentially next year against its event-driven analysis. It's my pleasure to share these data with you that were also published simultaneously in the Journal of Clinical Oncology on June 6, 2022.

Related Videos

Pancreatic Cancer

Pamela L. Kunz, MD, on Pancreatic Neuroendocrine Tumors: A Final Analysis of Temozolomide or Temozolomide Plus Capecitabine

Pamela L. Kunz, MD, of the Yale University School of Medicine, discusses new findings from the ECOG-ACRIN E2211 trial, which showed the longest progression-free survival and highest response rates with temozolomide plus capecitabine reported to date for patients with pancreatic neuroendocrine tumors. The presence of a deficiency of MGMT, the drug-resistance gene, was associated with greater odds of an objective response (Abstract 4004).

COVID-19

Jenny S. Guadamuz, PhD, on Racial and Socioeconomic Disparities in Telemedicine Use Among U.S. Patients With Cancer During the COVID-19 Pandemic

Jenny S. Guadamuz, PhD, of Flatiron Health, discusses the use of telemedicine services in community oncology clinics for patients initiating treatments for 21 common cancers during the COVID-19 pandemic. Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services. Although telemedicine may expand access to specialty care, the proliferation of these services may widen cancer care disparities if equitable access to these services is not ensured, according to Dr. Guadamuz (Abstract 6511).

Supportive Care
Symptom Management

Sriram Yennu, MD, on Cancer-Related Fatigue: Is Open-Labeled Placebo an Effective Treatment?

Sriram Yennu, MD, of The University of Texas MD Anderson Cancer Center, discusses the placebo response in patients with advanced cancer and cancer-related fatigue. His latest findings show that open-labeled placebo was efficacious in reducing cancer-related fatigue and improving quality of life in fatigued patients with advanced cancer at the end of 1 week. The improvement in fatigue was maintained for 4 weeks (Abstract 12006).

Myelodysplastic Syndromes

Ruben A. Mesa, MD, on Myelofibrosis: Phase III Results on Momelotinib vs Danazol

Ruben A. Mesa, MD, of Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, discusses new findings from the MOMENTUM study. This trial showed that in symptomatic and anemic patients with myelofibrosis, momelotinib was superior to danazol for symptom and spleen responses, as well as transfusion requirements (Abstract 7002).

Breast Cancer
Immunotherapy

Lisa A. Carey, MD, and Shanu Modi, MD, on Breast Cancer: Is T-DXd a Potential New Standard of Care for HER2-Low Disease?

Lisa A. Carey, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, discuss the phase III findings from the DESTINY-Breast04 trial, which compared fam-trastuzumab deruxtecan-nxki (T-DXd) vs treatment of physician’s choice (TPC) in patients with HER2-low unresectable and/or metastatic breast cancer. T-DXd is the first HER2-targeted therapy to demonstrate clinically meaningful improvement in progression-free and overall survival compared with TPC in this patient population, regardless of hormone receptor or immunohistochemistry status or prior use of CDK4/6 inhibitors (Abstract LBA3).

Advertisement

Advertisement




Advertisement