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Niloufar Mobashery
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-26 - EMPOWER-Lung 3: Phase 3 Study of Combinations of Cemiplimab and Chemotherapy in First-Line Treatment of Advanced NSCLC (ID 2173)
10:15 - 18:15 | Author(s): Niloufar Mobashery
- Abstract
Background
Most patients (pts) with non-small cell lung cancer (NSCLC) present with advanced disease at the time of diagnosis. Until recently, platinum-based doublet chemotherapy regimens were the standard of care first-line treatment for pts with advanced NSCLC whose tumors lack an EGFR, ALK, or ROS1 mutation. Despite chemotherapy, patients with metastatic NSCLC had a median overall survival (OS) of 8 to 12 months and a 5-year survival rate of approximately 18%. With the introduction of programmed cell death-1 (PD-1) inhibitors to NSCLC, this prognosis has improved. Cemiplimab, a human PD-1 monoclonal antibody, has exhibited antitumor activity and safety in a Phase 1 trial of advanced malignancies including NSCLC and was approved recently in the US as cemiplimab-rwlc for advanced cutaneous squamous cell carcinoma (CSCC). Based on their unique modes of action, combining cemiplimab with platinum‑based chemotherapy has the potential for a synergistic effect in pts with advanced NSCLC of both histologies and irrespective of PD-L1 expression.
Method
EMPOWER-lung 3 is a randomised, global, two-part, Phase 3 study of first-line treatment of pts with advanced squamous or non-squamous NSCLC (NCT03409614). Part 1, as previously described (IASLC 19th WCLC; Abstract 13347), is open-label and aims to describe the efficacy and safety of combinations of cemiplimab, ipilimumab, and platinum-based doublet chemotherapy in pts whose tumors express PD-L1 in <50% of the tumor cells. The updated primary endpoint of Part 1 is objective response rate.
Here we introduce the recently added Part 2. This part is double-blinded and will compare the efficacy and safety of cemiplimab versus placebo, both in combination with investigator’s choice of standard chemotherapy, in all pts irrespective of PD-L1 expression status. Chemotherapy options include: paclitaxel + carboplatin or cisplatin for squamous cell NSCLC and pemetrexed + carboplatin or cisplatin for non-squamous NSCLC. The investigator may choose from one of these regimens provided that it is consistent with the local standard-of-care. Pts will be randomized (2:1) to cemiplimab 350 mg Q3W plus up to four cycles of chemotherapy or placebo Q3W plus up to four cycles of chemotherapy. Pts will be stratified by histology and PD-L1 expression levels. The co-primary endpoints for Part 2 are OS and progression-free survival (PFS).
Result
Section not applicable
Conclusion
Section not applicable