Dr Hardesty on Updated Data With Frontline Niraparib Plus Bevacizumab Maintenance in Advanced Ovarian Cancer

"Across all comers, we saw really favorable OS [outcomes] compared with [those seen in] some other publications looking at similar groups of patients. Not surprisingly, we saw that the results [were even better] for patients who were either HRD or [displayed] a 

Melissa M. Hardesty, MD, a managing partner at Alaska Women’s Cancer Center, discusses overall survival (OS) outcomes with the combination of niraparib (Zejula) and bevacizumab (Avastin) as maintenance therapy for patients with newly diagnosed advanced ovarian cancer who responded to frontline platinum-based chemotherapy.

OS data from the phase 2 OVARIO trial (NCT03326193)

 and showed that OS outcomes with the combination of niraparib and bevacizumab were durable in patients with newly diagnosed advanced ovarian cancer who had responded to frontline platinum-based chemotherapy and that the regimen did not adversely affect health-related quality of life, Hardesty stated. At the data cutoff date of August 12, 2024, and a median follow-up of 65.7 months, the median OS in the overall population (n = 105) was 61.1 months (95% CI, 44.9-not evaluable [NE]), with data maturity for OS reaching 52.4%, Hardesty reported. These results showed favorable OS outcomes when compared with those observed in previous studies involving similar patient populations, Hardesty commented.

The study also provided insights into OS outcomes based on biomarker status, Hardesty explained. As expected, patients with homologous recombination deficiency (HRD) or a 

 mutation had superior OS outcomes compared with those without these biomarkers, Hardesty highlighted.

In the HRD population (n = 49), the median OS was NE (95% CI, 58.2-NE), Hardesty stated. Among those in the HRD population with 

-mutant (n = 29) and wild-type (n = 16) disease, the median OS was 68.3 months (95% CI, 52.5-NE) and NE (95% CI, 38.6-NE), respectively, Hardesty observed. The median OS in the homologous recombination–proficient population (n = 38) was 38.7 months (95% CI, 21.9-63.8), Hardesty reported. In the population of patients with undetermined homologous recombination status (n = 18), the median OS was 39.8 months (95% CI, 21.7-NE), Hardesty stated. Finally, in the overall population, among patients with 

-mutant (n = 29) and wild-type (n = 67) disease, the median OS was 68.3 months (95% CI, 52.5-NE) and 53.5 months (95% CI, 33.5-NE), respectively, Hardesty concluded.

Videos

Melissa M. Hardesty, MD, discusses OS and subgroup data from the OVARIO study of niraparib and bevacizumab maintenance in newly diagnosed ovarian cancer.

Melissa Hardesty, MD, gynecologic oncologist, Alaska Women’s Cancer Center, discusses the safety and efficacy of the bevacizumab (Avastin)/PARP inhibitor combination in ovarian cancer. She presented phase II findings from the OVARIO trial at the 2018 ASCO Annual Meeting.

Bevacizumab and niraparib (Zejula) is an aggressive and effective combination, particularly in upfront maintenance, and Hardesty says this won’t become the standard of care for all patients. There is a small fraction of patients who will be cured after frontline maintenance therapy, so physicians don’t want to put patients on 2 additional years of adjuvant therapy if they don’t need it. Hardesty says the best patient population for this combination would be those who have a suspected short disease-free interval. An example of these patients would be those who are diagnosed early on with stage IV disease.

Bevacizumab monotherapy has shown activity in these patient populations.

Melissa Hardesty, MD, gynecologic oncologist, Alaska Women’s Cancer Center, discusses the safety and efficacy of the bevacizumab/PARP inhibitor combination in ovarian cancer.

Dr. Hardesty on Bevacizumab/PARP Inhibitor Combination in Ovarian Cancer

Melissa Hardesty, MD, gynecologic oncologist, Alaska Women’s Cancer Center, discusses second-line maintenance therapy after frontline chemotherapy for patients with ovarian cancer. This is the basis of the OVARIO trial for which she is the lead investigator.

In the phase II single-arm study, patients with advanced ovarian, primary peritoneal, or fallopian tube cancer were treated with a combination of niraparib (Zejula) and bevacizumab (Avastin) after frontline platinum chemotherapy. The primary endpoint of the 2-year study is efficacy, with secondary focuses on progression-free survival and overall survival.

Hardesty says that most patients receiving chemotherapy alone will experience recurrence, and the average time to relapse is 18 months. Sometimes, she adds, it could be even quicker to recurrence; for example, if a patient has stage IV disease or if they have had a suboptimal surgical procedure.

The OVARIO trial is intended to extend the disease-free interval before second-line systemic therapy with maintenance agents.

Melissa Hardesty, MD, gynecologic oncologist, Alaska Women’s Cancer Center, discusses second-line maintenance therapy after frontline chemotherapy for patients with ovarian cancer.

Melissa Hardesty, MD

Articles

Dr Hardesty on Updated Data With Frontline Niraparib Plus Bevacizumab Maintenance in Advanced Ovarian Cancer

Dr. Hardesty on Bevacizumab/PARP Inhibitor Combination in Ovarian Cancer

Dr. Hardesty on Second-Line Maintenance Therapy for Ovarian Cancer