Entry Detail
| General information | |
| Database: | DB00858 |
| Objective: | This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel (C/P) would result in improved overall survival (OS) versus chemotherapy alone, in a subset of Asian patients with nonsquamous non small cell lung cancer (non small cell lung cancer). |
| Authors: | Kubota K, et al |
| Title: | Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non small cell lung cancer (non small cell lung cancer): Asian subgroup analysis. |
| Journal: | Ann Oncol. |
| Year: | 2014 |
| PMID: | 24419239 |
| Trial Design | |
| Clinical Trial Id: | NCT00460317 |
| Agent: | motesanib |
| Target: | Mast/stem cell growth factor receptor Plateletderived growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced nonsquamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | motesanib + carboplatin/paclitaxel |
| Study Type: | Phase III study (MONETI) |
| Key Patients Feature: | Patients with nonsquamous non small cell lung cancer (stage IIIB/IV or recurrent) and no prior systemic therapy for advanced disease |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | motesanib plus carboplatin/paclitaxel versus placebo plus carboplatin/paclitaxel |
| Treatment Info: | patients were randomized to IV carboplatin (AUC, 6 mg/ml min) and paclitaxel (200 mg/m2) for up to six 3week cycles, plus either oral motesanib 125 mg q.d. or placebo. |
| Primary End Point: | OS; |
| Secondary End Point: | progression free survival (PFS), objective response rate (ORR), and safety. |
| Patients Number: | 227 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 62% and 27%, respectively, (P<0.0001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.0 and 5.3 months, respectively, (P=0.0004) |
| Median OS A vs. C: | 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm (P=0.0223) |
| Adverse Event(agent arm): | The most common treatmentemergent AEs in the Asian subgroup are shown in Table 4. Neutropenia (44% versus 28%), hypertension (51% versus 9%), thrombocytopenia (21% versus 15%), diarrhea (63% versus 33%), and vomiting (38% versus 30%) occurred more frequently in the motesanib plus C/P group compared with the placebo plus C/P group. In addition, 9% of patients in the motesanib group had gallbladderrelated AEs (cholecystitis, cholecystitis acute, gallbladder enlargement, gallbladder edema) compared with 2% in the placebo group. Hypothyroidism was observed in 6% of patients receiving motesanib plus C/P versus <1% in those receiving placebo plus C/P. There was a low incidence of bleeding/thrombosis events, and no difference was observed between the two treatment arms |
| Conclusions: | In this preplanned subset analysis of Asian patients with nonsquamous non small cell lung cancer, motesanib plus CP significantly improved OS, PFS, and ORR versus placebo plus CP. |