LORBRENA Clinical Trial Results in Newly Diagnosed Patients
LORBRENA is being evaluated in a clinical trial. FDA approval for LORBRENA in newly diagnosed patients was based on an analysis of this trial at a
median of 18 months of follow-up. These were the main results of the study. Patients in the trial were given one of two medicines, LORBRENA or crizotinib. Crizotinib is a different medicine for ALK+ NSCLC.
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At enrollment, all patients were newly diagnosed with ALK+ NSCLC that had spread to other parts
of their body
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The study included patients with and without cancer that had spread to their brain
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No patients had received any previous treatment for NSCLC that had spread to other parts of
their body
The main result of the study was
progression-free survival (PFS).
PFS results from the trial were analyzed at a
median of 18 months. At that time, LORBRENA had reduced the chances of tumor growth by 72% compared to crizotinib.
More than half of the patients taking LORBRENA had not experienced tumor growth at the analysis with 18 months of follow-up. Therefore, the
medianprogression-free survival for LORBRENA had not been reached yet. Patients taking crizotinib experienced cancer progression at a
median of 9 months.
More time is needed to find out if patients taking LORBRENA live longer
than patients taking crizotinib.
The analysis at a
median of 18 months of follow-up also evaluated the
overall response rate. This measures tumor response to treatment, including tumor shrinkage and disappearance, throughout the body including the brain.
76% of patients had their tumors shrink or disappear while taking LORBRENA.
3% of patients taking LORBRENA had all signs of cancer disappear. This is known as a
complete response. It does not mean the cancer is cured. 0% of patients taking crizotinib had all signs of cancer disappear.
73% of patients taking LORBRENA had their tumors shrink. This is known as a
partial response. 58% of patients taking crizotinib had their tumors shrink.
These responses lasted 12 months or longer in 70% of patients taking
LORBRENA. They lasted 12 months or longer in 27% of patients taking crizotinib.
30 patients had
measurable brain tumors when the clinical trial began. 17 of these patients were treated with LORBRENA and 13 were treated with crizotinib.
12 out of 17, or 71%, of patients taking LORBRENA had their brain tumors disappear. This is known as a
complete response. It does not mean the cancer is cured.
2 out of 17, or 12%, of patients taking LORBRENA had their brain tumors shrink. This is known as a
partial response.
1 out of 13, or 8%, of patients taking crizotinib had their brain tumors disappear. 2 out of
13, or 15%, of patients taking crizotinib had their brain tumors shrink.
These responses lasted 12 months or longer in 79% of patients treated with LORBRENA and 0% of patients treated with crizotinib.
The patients in the clinical trial are still being monitored and data are being collected and evaluated. A follow-up analysis was done at a
median of 5 years, once more data were available.
This informal analysis was performed at a
median of 5 years of follow-up. It was not designed to find specific differences between LORBRENA and crizotinib. Unlike the main analysis, the data did not undergo an additional independent review, and it was not used to support the FDA approval of LORBRENA. The scientists, medical professionals, and the investigators assessed the informal analysis at 5-years of follow-up data. The following were observed:
- At 5 years, 60% of patients on LORBRENA had not experienced tumor growth. Therefore, the
median (50%)
progression-free survival still had not been reached
- At 5 years, 8% of patients on crizotinib had not experienced tumor growth
- At 5 years, LORBRENA had reduced the chances of tumor growth by 81% compared to crizotinib
No new safety concerns were detected in the follow-up analysis. The side effects experienced by patients in the main analysis were similar to those experienced in the follow-up analysis at a
median of 5 years.
LORBRENA Clinical Trial Results in Previously Treated Patients
LORBRENA was also evaluated in a clinical trial of 215 previously treated patients. The patients had ALK+ NSCLC that had spread to other parts of the body, including the brain. Their tumors were no longer responding to certain other medicines for ALK+ NSCLC.
This trial assessed the overall
response rate in previously treated patients. In this trial,
nearly half of patients had their tumors shrink or disappear with
LORBRENA.
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4% of patients treated with LORBRENA had all signs of cancer completely disappear. This is known as a
complete response. It does not mean the cancer is cured
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44% of patients treated with LORBRENA had their tumors shrink. This is known as a
partial response
These responses lasted for a
median of 13 months.
A smaller group of 89 patients had measurable brain tumors* that were no longer responding to certain other medicines for ALK+ NSCLC.
60% of these patients had their brain tumors shrink or disappear with LORBRENA.
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19 out of 89, or 21%, of patients taking LORBRENA had their brain tumors completely disappear. This is known as a
complete response. It does not mean the cancer is cured
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34 out of 89, or 38%, of patients taking LORBRENA had their brain tumors shrink. This is known as a
partial response
These responses lasted for a
median of 20 months.
*Of the 215 patients in the trial, 148 (69%) had brain tumors at the start of treatment. 89 of the 148 patients had brain tumors that could be measured.
