Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 215 · 1 trial · 1 indication
Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.
| Arm | Type | Description |
|---|---|---|
| ABP 215 | EXPERIMENTAL | Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. |
| Bevacizumab | ACTIVE_COMPARATOR | Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W |
| Paclitaxel | DRUG | Administered 200 mg/m² IV Q3W |
| ABP 215 | DRUG | Administered 15 mg/kg Q3W by IV infusion |
| Bevacizumab | DRUG | Administered 15 mg/kg Q3W by IV infusion |
Inclusion Criteria: * Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) * Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy * Eastern Cooperat...
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ABP 215 is an investigational drug being studied for the treatment of metastatic non-small cell lung cancer. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced non-small cell lung cancer.
ABP 215 is being developed by Amgen Inc., a biotechnology company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for metastatic non-small cell lung cancer.
ABP 215 is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 clinical trial has been completed to evaluate its efficacy and safety compared with an active control in patients with advanced non-small cell lung cancer.
ABP 215 has been studied in one completed Phase 3 clinical trial, identified as NCT01966003. This randomized, double-blind, active-controlled study enrolled 642 patients with advanced non-small cell lung cancer and was conducted in the United States, Australia, and Bulgaria.
ABP 215 is being studied as a potential biosimilar to bevacizumab. In the Phase 3 clinical trial NCT01966003, ABP 215 was compared directly with bevacizumab in patients with advanced non-small cell lung cancer to assess its efficacy and safety relative to the reference product.