Pembro monotherapy remains a standard of care in these pts. Zandberg is a medical oncologist and director of the head and neck cancer disease section at the UPMC Hillman Cancer Center. At data cutoff, 79 pts in each group had begun subsequent therapy 4 pts began a second course of pembro.Ĭonclusion: Similar to the global KEYNOTE-042 study, first-line pembro continues to prolong OS and provide durable response in pts in China with advanced/metastatic PD-L1-positive NSCLC without EGFR/ALK alterations after nearly 4 y of follow-up. Among 22 pts who completed 35 cycles of pembro, ORR was 81.8% (95% CI, 59.7%-94.8%) estimated OS rate 4 y after randomization was 69.1%. In the KEYNOTE-042 analysis, he pointed out, 'responses were very high for patients with G12C mutations, around 66, suggesting that we need to use pembrolizumab-containing options in comparator. 19.5% and 68.8% of pts in the pembro and chemo groups experienced treatment-related grade 3-5 AEs.
Pembro prolonged OS (HR, 95% CI) vs chemo in pts with PD-L1 TPS ≥50% (0.66, 0.45-0.95), ≥20% (0.68, 0.49-0.93), and ≥1% (0.67, 0.51-0.89 Table). Jayraj Recent keynote lectures at Gulbarga, for Karnataka Association of Surgeons of India conference. Median time from randomization to data cutoff (Apr 28, 2021) was 47.2 (range, 39.8-56.1) mo. KEYNOTE-042: is lowering the PD-L1 threshold for first-line pembrolizumab monotherapy a good idea Transl Lung Cancer Res. Results: 262 pts with PD-L1 TPS ≥1% were randomized in China to pembro (n = 128) or chemo (n = 134). No alpha was allocated to the China extension analysis. Background: STK11 (also known as LKB1) and KEAP1 mutations have been associated with chemoresistance and poor outcomes and shown to be more frequent in PD-L1-negative tumors with high tumor mutational burden (TMB). The pooled analysis included patients aged 18 years with advanced NSCLC with PD-L1-positive tumors from the KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894) studies. The OS benefit was driven largely by the patients with high PD-L1 scores and the lack of crossover indicates that at least some patients that would be candidates for additional therapy with checkpoint blockers did not have access to it, representing a possible explanation. Eligible pts who completed 35 cycles of pembro could receive a second course of pembro. Keynote-042 was a large study for which several observations can be made. Primary endpoints were OS in pts with PD-L1 TPS ≥50%, ≥20%, and ≥1%. Methods: Pts enrolled in China in the KEYNOTE-042 global (NCT02220894) and China extension (NCT03850444) studies were randomized 1:1 to pembro 200 mg Q3W for ≤35 cycles or carboplatin+paclitaxel or pemetrexed with optional pemetrexed maintenance (nonsquamous only). KEYNOTE-042 5-year survival update: pembrolizumab versus chemotherapy in patients with previously untreated, PD-L1positive, locally advanced or metastatic. We present efficacy and safety outcomes with an additional 14 calendar mo of follow-up in Chinese pts in KEYNOTE-042.
Among pts enrolled in China, pembro prolonged OS (HR 95% CI) vs chemo in pts with PD-L1 TPS ≥50% (0.63 0.43-0.94), TPS ≥20% (0.66 0.47-0.92), and TPS ≥1% (0.67 0.50-0.89). See the article 'Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial.' in Lancet, volume 393 on page 1819. The fourteen studies covered all regulatory-approved pembrolizumab NSCLC indications, including Keynote-010 (one study), Keynote-024 (six), Keynote-042. Mok, Yi‐Long Wu, +248 authors A.Background: In the global, phase 3 KEYNOTE-042 study, pembrolizumab (pembro) significantly prolonged OS vs chemotherapy (chemo) in patients (pts) with previously untreated advanced/metastatic NSCLC with PD-L1 TPS ≥1% without EGFR/ALK alterations.
#Keynote 042 trial#
Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial},Īuthor=,
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