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Clinical trial results with DATROWAY

DATROWAY was studied in 2 clinical trials that included adults with locally advanced Cancer that has spread outside the lung. or metastatic Cancer that has spread to other parts of the body. non-small cell lung cancer (NSCLC). Only some patients in these studies had a mutation in a gene called epidermal growth factor receptor (EGFR). The results shown here combine data from the patients with an EGFR mutation who received DATROWAY across both studies. These results apply only to this group of patients and do not represent the results of all patients who participated in the trials. DATROWAY was FDA-approved for this use based on clinical studies that measured how many patients responded and how long they responded. DATROWAY is still being studied to confirm these results.

About the trials

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The trials were conducted at research sites worldwide and were open-label, meaning both patients and doctors knew which treatment each patient received
114 people studied
The FDA approval of DATROWAY for this use was based on the combined results from 114 people with EGFR-mutated NSCLC who received DATROWAY in 2 clinical trials
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Patients must have received prior treatment with an EGFR-directed medicine and platinum-based chemotherapy for locally advanced or metastatic EGFR-mutated NSCLC
36-81 age range
The median age in the clinical trials was 63 years. This means about half of the patients were younger than 63, and about half were older

These results reflect combined data from a specific group of patients across both clinical trials and should be discussed with your doctor.

What the trials measured:

  • The primary endpoint for the subgroup of patients from these trials was overall response rate
  • A primary endpoint is the main result that is measured at the end of a trial to see if a treatment worked
  • In addition, these trials also looked at the duration of response

In clinical trials

How many people had their tumors shrink

Overall response rate results

Overall response rate is the percentage of patients whose cancer shrinks or disappears after treatment within a certain period of time. A partial response (PR) is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response (CR) is the disappearance of all signs of cancer in the body. In the clinical trials, 45% of people had their tumors shrink with DATROWAY.

Please remember that the results you will see are from clinical trials, and each person’s experience may differ. Speak with your doctor about what you may expect on DATROWAY treatment.

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45% of people had their tumors shrink with DATROWAY

40% of people had a partial response and 4.4% had a complete response.

Overall response rate was measured in 114 people from the
subgroup of people whose tumors could be measured.

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Median duration of response is the amount of time half of the people who had a first response to treatment (cancer shrinking or disappearing) to when the cancer grows or spreads, or the patient is no longer alive.

The median duration of response was 6.5 months with DATROWAY. In addition, 47% of people continued to respond for at least 6 months and 18% continued to respond for at least 12 months.

Overall response rate and median duration of response were not tested for statistical significance and the trials were not designed to show differences between treatments. Talk to your doctor if you have any questions.

Learn about possible
side effects Review the DATROWAY Getting Started Guide