New Hope for Fibrolamellar Carcinoma: SUMMIT Trial Findings

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the findings and key takeaways from the SUMMIT trial (NCT01953926), which evaluated the use of neratinib (Zejula) for the treatment of patients with fibrolamellar carcinoma.

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0:10 | If anything, number 1, the response rate was about 5% and the disease control rate was 13.3%, and this was for the single agent. However, when it came to the combination therapy, we had, for the first time ever—and this is literally the first time it has ever been reported for fibrolamellar carcinoma—in combination with pembrolizumab [Keytruda] as an anti-PD-1 therapy, and we achieved partial responses.

0:42 | We are delighted to say that patients tolerated the therapy very well. Yes, grade 3 and 4 adverse events did occur in about two-thirds of the patients, mainly related to hyperglycemia, hepatic failure, anaphylaxis. Otherwise, the combination therapy did not add on any other alterations or adverse events.

1:11 | So, in conclusion, we found that the combination of neratinib with checkpoint inhibitors is critical. We are not yet sure or fully appreciative of the added value of mTOR inhibition in combination, even though we have a theoretical rationale for mTOR inhibition, as we have previously published regarding the disease. Nonetheless, we can say this is a step in the right direction.

1:38 | The big challenge we have is that, because of the rarity of the disease, sponsors are limited in their interest in fibrolamellar carcinoma. But we are grateful for any sponsor who comes to us and says they would like to work with us on this disease. Why is that? Because we owe it to everyone. We owe it to our young patients with this terrible disease, who still do not have a standard care therapy.