Publication: Pembrolizumab plus ipilimumab or placebo in previously untreated metastatic NSCLC with PD-L1 tumor proportion score >= 50%: KEYNOTE-598 3-year follow-up
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Date
2022-04-01
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Abstract
Background: At protocol-specified interim analysis 1 (IA1; data cutoff Sep 1, 2020) of
the phase 3 KEYNOTE-598 study (NCT03302234), adding ipilimumab (ipi) to pembrolizumab (pembro) did not improve OS (HR, 1.08) or PFS (HR, 1.06) vs placebo (pbo)
+ pembro in patients (pts) with previously untreated stage IV NSCLC with PD-L1 tumor
proportion score (TPS) 50%. Per external DMC recommendation at IA1, ipi and pbo
were discontinued and pembro monotherapy continued in both arms. We report 13
additional mo follow-up from IA1 and outcomes of pts who completed 35 cycles of
pembro and pts who started second-course pembro.
Methods: Eligible pts were randomized 1:1 to ipi 1 mg/kg or pbo Q6W for up to 18
doses (stratified by ECOG PS [0 vs 1], region [East Asia vs non-East Asia], and histology
[squamous vs nonsquamous]). All pts received pembro 200 mg Q3W for up to 35
cycles. Dual primary endpoints were OS and PFS per RECIST v1.1 by BICR.
Results: 568 pts were randomized to pembro + ipi vs pembro + pbo (n ¼ 284 each).
Median time from randomization to data cutoff (Oct 1, 2021) was 33.6 (range, 25.4-
44.6) mo. After discontinuing ipi/pbo for all pts, median OS and PFS remained similar
between groups (Table). Grade 3-5 treatment-related AEs occurred in 99/282 (35.1%)
vs 57/281 (20.3%) pts in the pembro + ipi vs pembro + pbo arms, respectively. Among
52 pts vs 71 pts initially treated with pembro + ipi vs pembro + pbo who completed 35
cycles of pembro, ORR was 88.5% vs 87.3%, respectively; OS and PFS rates 1 y from
completing pembro were 86.3% vs 87.6% and 72.8% vs 83.5%, respectively. 11 pts
started second-course pembro
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Tıp, Sağlık Bilimleri, Dahili Tıp Bilimleri, İç Hastalıkları, Onkoloji, Medicine, Health Sciences, Internal Medicine Sciences, Internal Diseases, Oncology, ONKOLOJİ, Klinik Tıp, Klinik Tıp (MED), ONCOLOGY, CLINICAL MEDICINE, Clinical Medicine (MED)
Citation
Abreu D. R., Reck M., Sendur N., Park K., Lee D. H., Cicin I., Yumuk P. F., Orlandi F. J., Leal T. A., Soparattanapaisarn N., et al., "Pembrolizumab plus ipilimumab or placebo in previously untreated metastatic NSCLC with PD-L1 tumor proportion score >= 50%: KEYNOTE-598 3-year follow-up", ANNALS OF ONCOLOGY, cilt.33, 2022