Congress highlights
Join us for congress highlights on PARP inhibitor treatment of ovarian cancer at ESMO 2022, ASCO 2022, ESMO 2021 and ASCO 2021.
- Discover the emerging clinical trial data in the first-line and recurrent maintenance settings
- Learn about the real-world outcomes achieved with PARP inhibitor treatment
- Find out how PARP inhibitor treatment outcomes are being improved in different patient groups
In this section
ESMO 2022
Ovarian cancer update and the theme of ESMO 2022
By Heather L. Mason
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ASCO 2022
Join Professor Antonio Gonzalez Martin in this series of videos to hear about ovarian cancer treatments that were discussed at the ASCO 2022 congress.
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The European Society for Medical Oncology (ESMO) Congress was held virtually from 16–21 September 2021, and it featured a range of exciting developments in the field of oncology. The full programme included plenary debates, mini oral sessions and proffered paper sessions, unveiling the latest advances in the fight against ovarian cancer.
PARP inhibitors in the first-line and recurrent maintenance setting
Professor Eric Pujade-Lauraine and colleagues presented the results of the OReO/ENGOT Ov-38 trial, which is, according to the authors, the first Phase III study evaluating PARP inhibitor maintenance rechallenge in platinum-sensitive relapsed ovarian cancer patients.
This randomised, double-blind trial evaluated patients with non-mucinous platinum-sensitive relapsed ovarian cancer who had received one prior line of PARP inhibitor maintenance therapy, and had responded to their most recent platinum-based chemotherapy. Patients were enrolled into BRCA1/2 mutated and non-BRCA mutated cohorts, and randomised to receive olaparib or placebo until progression.
The trial met its primary endpoint of investigator-assessed progression-free survival (RECIST v1.1). The results indicate that irrespective of BRCA mutation status, maintenance olaparib led to a significant improvement in progression-free survival compared to placebo. In addition, clinically relevant long-term benefit was observed in a subset of patients studied, and safety was consistent with olaparib’s known safety profile.
In other news, Dr. Manuel Rodrigues and colleagues presented the results of their study into real-world clinical outcomes in patients in France with de novo high-grade epithelial ovarian cancer eligible for niraparib per EMEA approval (the PRIMA trial). Their analysis of 488 patients with a median follow-up of 36 months indicated an estimated 36-month overall survival rate of 65.6% (95% CI, 59.1–72.1). The team concluded that clinical outcomes in patients with high-grade epithelial ovarian cancer (HGEOC) can be confirmed by analysis of large real-world cohorts with structured data. The results of this study aligned with the results of clinical trials for de novo HGEOC patients who responded to first-line platinum-based chemotherapy without maintenance therapy (bevacizumab or PARP inhibitor).
PARP inhibitors in the maintenance setting
Based on the ARIEL3 trial results, rucaparib was approved as monotherapy for maintenance treatment of recurrent epithelial ovarian cancer in which patients had prior complete/partial response to platinum-based chemotherapy. In a presentation by Dr. Mark Lythgoe and colleagues, they expressed the need for more real-world evidence of rucaparib treatment as it applies to routine practice. In their presentation, Dr. Lythgoe et al. shared the results of their multi-centre retrospective study, in which 119 patients receiving rucaparib in the UK via an early access program were studied. The results indicated a lower incidence of toxicity (any grade and grade 3/4), and discontinuation rates comparable with those observed in ARIEL3. Although they observed lower overall progression-free survival and BRCA mutation progression-free survival than in ARIEL3, when they applied similar inclusion and exclusion criteria to this real-world sample, progression-free survival findings were commensurate.
Improving PARP inhibitor treatment outcomes
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PARP inhibitors in the maintenance setting
PARP inhibitors have already been approved for frontline maintenance therapy in ovarian cancer, and many talks at ASCO 2021 focused on emerging data in this setting. According to a presentation at ASCO 2021, the SOLO-1 trial’s 5-year follow-up demonstrated that maintenance treatment with olaparib in women with newly diagnosed, advanced ovarian cancer and a BRCA1/2 mutation led to more than doubling in progression-free survival (PFS). The author, William Bradley, claims the results are extremely positive and that they are appreciated across both higher- and lower-risk groups. The median PFS for the olaparib arm was 56.0 months and 13.8 months for those in the placebo arm, and 5-year rates of 48% vs 21%, respectively. Additionally, no new safety signals were reported.
New data analyses from the phase III ARIEL3 and ARIEL4 trials highlighted the efficacy and consistency profile of rucaparib in patients with advanced ovarian cancer in the maintenance setting. Oza et al, the authors of the ARIEL4 trial, demonstrated that patients treated with rucaparib had a longer PFS compared to standard-of-care platinum-chemotherapy in all subgroups. More so, safety profiles for rucaparib were consistent with known safety profiles, and results suggest that rucaparib is an effective treatment option compared to chemotherapy for patients with a BRCA mutation who have been heavily pretreated and have advanced, relapsed ovarian cancer. Kwan et al, the authors of the ARIEL3 trial suggest that rucaparib shows an exceptional benefit (PFS ≥2 years) in patients with favourable clinical characteristics and known mechanisms of poly(ADP-ribose) polymerase (PARP) inhibitor sensitivity. In the rucaparib arm, 21% of patients derived exceptional benefit versus only 2% in the placebo arm of the trial. Additionally, among rucaparib-treated patients, incidence rates of the most common adverse events were generally consistent between the exceptional benefit subgroup and the overall ARIEL3 patient population.
PARP inhibitors in the first-line and recurrent maintenance setting
Last year, results from three trials were presented evaluating the efficacy of PARP inhibitors in first-line therapy of ovarian cancer. This year, at ASCO 2021, many more abstracts presented their use in this setting. The results of three phase II trials on the safety and efficacy of niraparib, namely PRIMA/ENGOT-OV26/GOG-3012 (PRIMA; NCT02655016), ENGOT-OV16/NOVA (NOVA; NCT01847274), and NORA (NCT03705156), were reported at ASCO 2021. Niraparib has already been approved for maintenance treatment of patients with advanced ovarian, fallopian tube or primary peritoneal cancer following front-line chemotherapy but the safety and efficacy in patients with BRCA mutated ovarian cancer was summarized across these trials. In the PRIMA trial, patients enrolled had been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (at stage III or IV high-grade serous or endometrioid tumours). In the NOVA and NORA studies, patients had a platinum-sensitive high-grade serous ovarian, fallopian tube, or primary peritoneal cancer, and had already received 2 lines or more of platinum-based chemotherapy regimens.
All three trials met the primary endpoint of progression-free survival (PFS), demonstrating a significant PFS benefit from niraparib maintenance treatment, with hazard ratios of 0.40 (CI, 0.270.62;), 0.27 (CI, 0.170.41) and 0.22(CI, 0.120.39;) for the PRIMA, NOVA and NORA trials, respectively. More importantly, no big or meaningful differences were observed in terms of the toxicity profile when these PARP inhibitors were used as front-line therapy compared to second-line maintenance.
PARP combinations with other treatments
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