Combination of motesanib, a taxane and a platinum-containing anti-cancer drug for use in the treatment of non-small cell lung cancer in a population subset
A technique for non-small cell lung cancer, Motesanib, in the field of improving cancer-related survival
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Embodiment 1-N
[0109] Example 1 - NSCLC
[0110] Enrolled patients (≥18 years old) with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB or IV with malignant exudate), Eastern Cooperative Oncology Group (ECOG) performance status ≤1, Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) and life expectancy ≥ 3 months. Patients with the following were excluded: central nervous system metastases; history of pulmonary hemorrhage or severe hemoptysis; bleeding diathesis or non-pulmonary hemorrhage within 6 months of randomization; uncontrolled hypertension (>150 / 90 mmHg) ; peripheral neuropathy grade > 1; cardiac, hepatic, hematologic, or renal insufficiency; prior chemotherapy or adjuvant chemotherapy for advanced NSCLC within 52 weeks of randomization; prior targeted therapy; within 7 days of randomization Anticoagulant therapy; prior chemoradiation for locally advanced stage III disease; central radiation ther...
Embodiment 2
[0128] Example 2 - Efficacy Outcomes and Baseline Distribution in Asian Subgroups
[0129] The Asian subgroup (N=219) included patients from Japan, South Korea, Singapore, Philippines, Taiwan, and China (Hong Kong). Japan has provided 107 patients and South Korea has 63 patients. Demographic and baseline characteristics were balanced between the two groups (Table 4).
[0130] Table 4 Baseline Demographics - Asian Patients Only
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[0132] At the time of analysis, 132 Asian patients had died. OS, PFS and response were significantly improved in motesanib Arm A compared to placebo Arm B ( Table 5-7 ).
[0133] A Kaplan Meier Plot using the fraction of patients surviving treatment with motesanib and based on days of survival showed an increase in overall survival. [ image 3 ]. The median was 20.9 months vs. 15.5 months for placebo. Cox proportional hazards - P = 0.017; hazard ratio = 0.657; (95% CI: 0.465, 0.929).
[0134] Kaplan Meier Plot using the fr...
Embodiment 3
[0159] Example 3 - Efficacy Outcomes and Baseline Distribution of Non-Asian Subgroups
[0160] The non-Asian subgroup (N=871) included patients not of ethnicity from Japan, Korea, Singapore, Philippines, Taiwan, and China (Hong Kong). At the time of analysis, 621 non-Asian patients had died. OS, PFS and response improved in Motesanid Arm A compared to placebo Arm B ( Table 8-10 ).
[0161]A Kaplan Meier Plot using the fraction of patients surviving treatment with motesanib and based on days of survival showed an increase in overall survival. [ Figure 5 ]. The median was 10.9 months vs. 10.7 months for placebo. Cox proportional hazards - P = 0.774; hazard ratio = 0.977; (95% CI: 0.835, 1.144).
[0162] Kaplan Meier Plot using the fraction of patients surviving treatment with motesanib and the number of days of progression-free survival showed an increase in progression-free survival. [ Figure 6 ] The median was 5.5 months vs. 5.4 months. Cox proportional haz...
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