Overall, 47.6% of patients who received the combination treatment went on to receive subsequent systemic treatment of any type compared with 66.1% of patients who received monotherapy.Īmong patients who received subsequent anticancer therapy with a PD-1/PD-L1 inhibitor, 21.6% were treated with the combination (N = 432) and 74.4% were treated with monotherapy (N = 429). CPS less than 1 was 38.7% in the combination arm vs 34.2% in the monotherapy arm. Regarding PD-L1 status, combined positive score (CPS) greater than 1 was 58.3% in the combination arm vs 61.6% in the monotherapy arm. Average age was 61 years and 71.6% of participants were male in the combination arm (n = 204) compared with 77.6% in the monotherapy arm (n = 281). Patients in the combination arm had an overall response rate (ORR) of 60.4% (95% CI, 55.6%-65.1%) compared with the monotherapy arm of 39.6% (95% CI, 35.0%-44.4%).īaseline characteristics were similar for both arms. Patients in the combination arm had a 32% lower risk of death (HR, 0.68 95% CI, 0.58-0.80). Median PFS was 15.7 months in the combination arm (95% CI, 13.6-20.2) compared with 11.1 months in the monotherapy arm (95% CI, 8.9-12.5). Patients in the combination arm had a 27% lower risk of death compared with the monotherapy arm (HR, 0.73 95% CI, 0.60-0.88). In the combination arm, median OS was 45.7 months (95% CI, 43.6-not reached) and in the monotherapy arm, median OS was 40.1 months (95% CI, 34.3-44.2). Reasons for discontinuing included radiographic PD (n = 51), AEs (n = 30), and patient’s decision (n = 11). In this arm, 145 patients did not receive subsequent treatment, with 40 patients receiving ongoing treatment and 105 patients who discontinued. There were 192 patients who discontinued because of radiographic PD, 48 patients discontinued due to AEs, and 14 patients decided to discontinue. In the monotherapy arm, 281 patients received subsequent treatment. Reasons for discontinuing included radiographic PD (n = 64), AEs (n = 52), and 11 patients decided to discontinue. There were 225 patients who did not receive subsequent treatment, with 15 completing the regimen, 62 had ongoing treatment, and 148 patients who discontinued. Among those who discontinued, 150 patients demonstrated radiographic progressive disease (PD), 31 reported adverse events (AEs), and 8 patients decided to discontinue. In the monotherapy arm, 40 (90.4%) patients had ongoing treatment and 385 (90.6%) had discontinued.Īt the median follow-up of 42.8 months (range, 35.6-50.6), 204 patients in the combination arm received subsequent treatment with 3 who completed the regimen there were 201 patients who discontinued treatment. In the combination arm, 18 (4.2%) patients completed treatment, 62 (14.5%) patients had ongoing treatment, and 349 (81.4%) patients discontinued. There were 432 patients assigned to the combination arm and 429 were treated there were 429 patients assigned to the monotherapy arm, with 425 patients receiving treatment.
#KEYNOTE 426 PLUS#
The investigators report that patients were assumed to be at a similar stage of disease in stage 1, ie, TSE model without recensoring.Īt the data cutoff of January 21, 2021, 861 patients were randomly assigned to receive either pembrolizumab plus axitinib or sunitinib. Survival time was adjusted multiplicatively by the acceleration factor that was determined in stage 1 of the trial. In stage 2, survival time was determined after patients received the combination treatment of pembrolizumab and axitinib vs sunitinib. Using a 2-stage estimation (TSE) model, investigators determined the effect, called the acceleration factor, of subsequent anticancer therapy for patients in KEYNOTE-426 (stage 1). The findings, which showed a benefit for the immunotherapy/TKI regimen in adjusted overall survival (OS) as well as in the type and timing of subsequent therapy, were shared in a poster during the 2021 ESMO Congress by principal investigator Rustem Gafanov, MD, Russian Scientific Center of Roentgenoradiology, and his coinvestigators. The latest results of the phase 3 KEYNOTE-426 study offered further insight into the extent of the benefitof pembrolizumab (Keytruda) plus axitinib (Inlyta) over single-agent sunitinib (Sutent) in patients with clear cell renal cell carcinoma (ccRCC).
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