A wide range of cancers exhibit some EGFR mutation and fusion but at varying frequency; so, for

example, in breast cancer it’s less than 1%, in lung cancer less than 1%. So the idea of this trial is to

conduct a tumour agnostic trial where patients with solid tumours and EGFR alterations, so mutations

and fusions, are treated with an EGFR inhibitor erdafitinib. This drug is approved in metastatic bladder

cancer. Why? Because we have the phase II trials that show that erdafitinib produces an objective

response rate of 40% so, based on this data, we’ve conducted a tumour agnostic trial just to have an

idea of the activity and safety of this drug across tumour histologies.

It’s an open label, single-arm, tumour agnostic phase II trial where patients with solid tumours and

EGFR1, 2, 3, 4 mutation and fusion are treated with erdafitinib. The primary endpoint is the objective

response rate. We need 200 assessable patients and today we report the third interim analysis, so

178 patients are included in this analysis.

The objective response rate is 29.2%; the disease control rate is 75.2% so it’s quite striking across

tumour histologies. We have a median PFS of 5.2 months and a duration of response 7 months.

Clinical activity was observed across tumour histologies in hard to treat cancers - pancreatic cancer,

salivary gland tumour, high grade glioma. Regarding safety, it’s generally manageable with a safety

profile very consistent as has been reported in metastatic bladder cancer in the past.

What are the next steps for this study?

We need the primary analysis; as I said before, it’s an interim analysis today. So we need to do the

primary analysis. It will be conducted late this year and we hope to confirm, of course, this interim

analysis. If so, what we want to do is to provide the drug in daily practice in the US, in Europe,

worldwide, for the patients with solid tumours and prespecified tumours, prespecified EGFR

alterations.