Phase 3 SOLO2/ENGOT-ov21 Trial Shows Promise for Maintenance Olaparib in Ovarian Cancer

The results of the phase 3 SOLO2/ENGOT-ov21 trial, presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, showed that maintenance olaparib (Lynparza) provided an unprecedented improvement in median overall survival (OS) versus placebo in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation.

In an interview with CancerNetwork®, Andres Poveda, MD, of the Fundación Instituto Valenciano de Oncologia in Valencia, Spain, discussed the findings from the study and what makes the results exceptional.

CancerNetwork®: Could you first explain the study design of the phase 3 SOLO2/ENGOT-ov21 trial?

Poveda: The study design is for patients with high-grade serous ovarian cancer and BRCA mutation. Patients were randomized to olaparib tablets or placebo and continued the study treatment until disease progression. And a key secondary endpoint is overall survival. The study was designed knowing that olaparib is active in BRCA mutated patients, according to the previous information of some different studies. And 3 years ago, the report of the PFS was really brilliant and incredible. The results that we have now are the overall survival results.

What were the key findings from the study?

The final analysis, median overall survival, improved by close to 15 months with maintenance olaparib over placebo. This is impressive, so this is the first time in the last close to twenty years that we have had benefit in overall survival for patients in relapsed ovarian cancer… And this is the reason why we are so happy according to the results, because our patients will enjoy this benefit in overall survival, which is so difficult to obtain in patients with relapsed ovarian cancer.

So, what would you say are the most important implications of these findings?

Well, you know, in regard to the patient, overall survival improving more than 1 year is impressive. It’s something that we have never seen before. The second is that, in my opinion, that patients can make a regular life because the maintenance therapy is… they’re by tablets, so regular life is really something that for the patients is absolutely important in order to avoid going to the hospital frequently. The tolerability is good, so safety is okay. So, we presented data on overall survival because we make it long term regarding the paper with PFS 2 years, and it’s more or less the same tolerance. I think that also, a relevant finding is the time to subsequent treatment. That means that patients delaying, they need to subsequent treatment. Not only overall survival is crucial, but time to subsequent treatment is also crucial because it means that patients can… and wait for some new chemotherapy treatment.

For patients who may not understand medical jargon, how would you explain the results of the study?

Well, first of all I’ve always thanked all the patients and families because they are involved in clinical trials so that means that they are the real alphas of this study. So, I explain to my patients that olaparib gives advantage in overall survival. And that means that not only does it delay progression, but it also improves survival. And this is important because this is the first time that a PARP inhibitor has reported benefit in overall survival.

So, are there any next steps for this study?

Well, we are still waiting for some analysis in regard to different subgroups of different BRCA status. But they will be included in the final manuscript coming soon.