Niraparib Shows Potential in Rare Fibrolamellar Carcinoma

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses neratinib (Zejula) and its use as a monotherapy and in combination with immune checkpoint inhibitors and/or mammalian target of rapamycin (mTOR) inhibitors in the SUMMIT trial (NCT01953926).

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0:10 | I am delighted to share with you today our latest results and our latest publication on niraparib in combination with checkpoint inhibitors or with rapamycin inhibitors in patients with fibrolamellar carcinoma. Fibrolamellar carcinoma is, sadly, a disease that still does not have a standard care therapy, as it affects only about 200 people worldwide. However, it tends to affect younger individuals, with more females than males, and still, there is no standard of care treatment for them.

0:43 | So, why did we choose niraparib specifically? Because, as we all know, we have a specific, targeted understanding of what can affect fibrolamellar carcinoma due to the fusion of DNAJB1 and PRKACA. We know very well that an anti-HER2 treatment might play a role in that regard, and that's why we decided to evaluate the retina, per se. Of course, we also discovered that adding on potential targets such as checkpoint inhibitors or mTOR inhibition will probably enhance that potential further.

1:27 | For that, we went ahead with that study that evaluated patients with fibrolamellar carcinoma. First, we did evaluate the single-agent niraparib, and then we carried on with further combination therapies as well. What did we find out? I understand, because of the rarity of the cancer, we actually ultimately accrued a total of 15 patients on the study, and if anything, the aim was to look into the single-agent, as we said, as well as combination therapy. There is no doubt that the results were rather positive—intriguingly positive, I would say. And that is intriguingly positive because certain parts of [the data were awakening].