I think what is important to stress here is that the toxicity is manageable in the vast majority of women. Although we need to reduce the dose of the drug in about 50%, they were able to continue therapy, and only about 13% of patients actually withdrew from the trial because of unacceptable toxicity. So, for the majority of patients who are not progressing, they can continue the drug for a long period of time without significantly affecting their quality of life.
What impact do you believe these results will have on maintenance therapy in ovarian cancer?
What we already have on this side of the ocean is a license of maintenance olaparib (Lynparza) in patients with BRCA
-mutant ovarian cancer, but we have recently gotten the results of the NOVA trial with niraparib, which was again, in an all-comer population. That study showed that there was a significant benefit across all groups, so BRCA
positive and BRCA
wild-type. That has led to a license in the United States, and now the license for olaparib has been extended in the United States, and it is just as active as any other drug in the BRCA
–wild-type population. So, we have 2 drugs that are licensed for all patients with platinum-sensitive ovarian cancer, responding to platinum, and then we have a maintenance PARP inhibitor.
Rucaparib is the third of those, and I am quite confident that the company will get a license in that similar indication—so not only in BRCA
positive, but also in wild-type, and with the spectrum of activity that I mentioned, with more activity in the LOH-positive than the LOH-negative [patients], but it is still active in all patients. I think we will have a new drug that is available for all patients with platinum-sensitive ovarian cancer, but the tricky thing for us as clinicians is to decide which of the 3 to use.
What do you hope that oncologists take away from these results?
I think we have waited a long time for confirmation that we have agents that will truly impact the PFS in women with ovarian cancer. We have known now for some years that patients with a BRCA mutation will respond very well to a PARP inhibitor, but now there is a growing body of evidence that we have seen with all 3 PARP inhibitors—rucaparib, niraparib, and olaparib—that these drugs are active beyond patients with a BRCA
Going forward, we have a completely new standard of care, namely giving a PARP inhibitor to patients who respond to platinum-based chemotherapy, leading to a significant improvement in their PFS.