LORBRENA Clinical Trial Results in Newly Diagnosed Patients
LORBRENA was evaluated in a clinical trial of 296 patients with ALK+ NSCLC whose cancer had spread to other parts of the body, including the brain. LORBRENA was compared to crizotinib, which is a different treatment for ALK+ NSCLC. All of the patients included in this trial were newly diagnosed and had not taken any treatment for their cancer.
The primary endpoint of this trial was
progression-free survival, which is the length of time patients are living without their tumors growing or spreading (“progressing”).
LORBRENA reduced the risk of cancer growing or spreading by 72% compared to crizotinib. After a
median of 9.3 months, half of crizotinib patients were living without their tumors growing or spreading, and half were not. At the time of the analysis, more than half of LORBRENA patients were still living without their tumors progressing. Therefore, the
median time point when half of patients were living without their tumors progressing is not yet known for LORBRENA. More time is needed to determine whether or not LORBRENA helps patients live longer.
This study also assessed the overall response rate. This measures tumor response to treatment, including tumor shrinkage, throughout the body or specifically within the brain. In this study,
76% of patients had their tumors shrink or disappear with LORBRENA.
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3% of patients taking LORBRENA had all signs of cancer completely disappear (known as a
complete response, although this does not mean the cancer is cured) compared to 0% of patients taking crizotinib
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73% of patients taking LORBRENA had their tumors shrink (known as a
partial response) compared to 58% of patients taking crizotinib
These responses were ongoing in the majority of patients taking LORBRENA and lasted at least 12 months in 70% of patients. In patients taking crizotinib, responses lasted for a
median of 11 months, and lasted at least 12 months in 27% of patients.
In a smaller group of 17 patients who had measurable brain tumors,*
82% of patients had their brain tumors shrink or disappear with LORBRENA.
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12 out of 17, or 71%, of patients taking LORBRENA had their brain tumors completely disappear (known as a
complete response), although this does not mean the cancer is cured), compared to 1 out of 13, or 8%, of patients taking crizotinib
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2 out of 17, or 12%, of patients taking LORBRENA had their brain tumors shrink (known as a
partial response), compared to 2 out of 13, or 15%, of patients taking crizotinib
These responses lasted at least 12 months in 79% of patients treated with LORBRENA and 0% of patients treated with crizotinib.
*Of the 296 patients in the trial, 78 had brain tumors at the start of treatment, including 30 patients who had brain tumors at the start of treatment, that could be measured. Of those 30 patients, 17 were treated with LORBRENA.
LORBRENA Clinical Trial Results in Previously Treated Patients
LORBRENA was also evaluated in a clinical trial of 215 previously treated patients with ALK+ NSCLC that had spread to other parts of the body, including the brain, and whose tumors were no longer responding to certain other medicines for ALK+ NSCLC.
This study assessed the overall response rate in previously treated patients. In this study,
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 (known as a
complete response, although this does not mean the cancer is cured)
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44% of patients treated with LORBRENA had their cancer shrink (known as a
partial response)
These responses lasted for median of 12.5 months.
In a smaller group of 89 patients who had measurable brain tumors* that were no longer responding to certain other medicines for ALK+ NSCLC,
60% of 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 (known as a
complete response, although this 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 (known as a
partial response)
These responses lasted for median of 19.5 months.
*Of the 215 patients in the trial, 148 (69%) had brain tumors at the start of treatment, including 89 patients who had brain tumors that could be measured.
