KEY TAKEAWAYS
- EMPOWER- Lung 3 is a Phase 3 study that assessed the efficacity and safety of cemiplimab combined with platinum-grounded chemotherapy versus placebo with placebo chemotherapy in cases with advanced (Stage III/ IV) SQ or NSQ NSCLC without practicable mutations.
- 466 cases were aimlessly allocated in a 21 rate, with 312 cases entering cemiplimab plus chemotherapy and 154 entering placebo plus chemotherapy.
- Overall survival was significantly dragged with cemiplimab plus chemotherapy compared to placebo plus chemotherapy(21.9vs.13.0 months; HR,0.71; P = 0.014).
- Progression-free survival, ORR, and DOR were also significantly bettered with the cemiplimab plus chemotherapy arm(8.2 vs 5.0 months; HR,0.56; 43.3 vs 22.7; 15.6 months vs. 7.3 months, independently).
EMPOWER- Lung 3 is a randomized, two-part, Phase 3 study of first-line treatment for cases( pts) with advanced( Stage III/ IV) scaled( SQ) or non-squamous (NSQ)non-small cell lung cancer( NSCLC) without practicable mutations (NCT03409614). The double-eyeless Part 2 of the study enrolled pts of PD- L1 situations and compared the clinical exertion and safety of cemiplimab, an anti-PD-1, plus platinum-grounded chemotherapy, versus placebo( PBO) chemo. Styles In the study, 466 pts were aimlessly assigned in a 21 rate stratified by histology and PD- L1 expression to admit cemiplimab 350 mg every three weeks( Q3W) or PBO Q3W for 108 weeks( or until progression), plus up to four cycles of chemotherapy( followed by obligatory pemetrexed conservation for NSQ pts assigned to pemetrexed- containing authority).
The primary endpoint was overall survival(zilch), while the critical secondary endpoints included progression-free survival( PFS) and objective response rate( ORR) as per the dazed independent central review. Then, the results of Part 2 from the pre-specified two interim analyses were reported with data cut-off on 14 June 2021. Results The cases’ standard( range) age was 63.0 ( 25- 84) times;57.1 had NSQ NSCLC, and 85.2 had Stage IV complaints. Median zilch was 21.9 months with cemiplimab chemo versus 13.0 months with PBO chemo( HR,0.71; P = 0.014). Cemiplimab chemo was associated with superior median PFS(8.2 vs5.0 months; HR,0.56), advanced ORR(43.3 vs22.7), and longer median duration of response( DOR)(15.6 months vs7.3 months) compared to PBO chemo( Table).
The prevalence of Grade ≥ 3 adverse events was 43.6 in the cemiplimab chemo arm and 31.4 in the PBO chemo arm. The results from this trial demonstrate that among pts with advanced NSCLC, first-line cemiplimab chemo treatment yielded clinically meaningful and statistically significant enhancement in OS, PFS, ORR, and DOR versus chemotherapy alone, with a safety profile harmonious with cemiplimab monotherapy and platinum- grounded chemo.
Source:https://oncologypro.esmo.org/meeting-resources/esmo-asia-congress/empower-lung-3-cemiplimab-in-combination-with-platinum-doublet-chemotherapy-for-first-line-1l-treatment-of-advanced-non-small-cell-lung-cancer
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03409614
Annals of Oncology (2022) 33 (suppl_9): S1560-S1597. 10.1016/annonc/annonc1134
