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Patients with renal transparent cell carcinoma (ccRCC) in the advance stage of paboliju monotherapy were safe and effective and had a long-lasting response (ORR, 36.4%; CR, 3.6%; PR, 32.7%).
February 2, Journal of Clinical Oncology published an open label, single arm, and clinical Phase II study of the single-drug treatment of ccRCC patients.
study aims to study the efficacy and safety of PD-1 inhibitor Pabliju monodrative therapy in patients with relapsed or advanced or metastatic ccRCC who have not received systemic anti-cancer treatment.
study included 110 patients, with ORR of 36.4% (95% CI, 27.4 to 46.1), of which 4 (3.6%) were fully remission and 36 (32.7%) were partially relieved.
disease control rate was 58.2% (95% CI s 48.4-67.5).
the majority of patients (68.2 per cent, 75/110) had a reduction in lesions, of which 30.9 per cent (34/110) had a 60 per cent reduction in lesions.
18.9 months, and 64.1% of respondents had a mitigation duration of more than 12 months.
the medium non-progressed lifetime was 7.1 months (95% CI -5.6-11.0), with a PFS rate of 37.6% in December and 22.3% in December.
did not reach the mid-level OS, with OS rates of 88.2% in December and 70.8% in 24.
42 patients had a good IMDC risk and 68 patients had a moderate or adverse IMDC risk.
results of the IMDC risk category showed that the ORR of the good IMDC risk group was 31.0% (95% CI, 17.6 to 47.1), of which 1 case (2.4%) was fully mitigated and 12 cases (28.6%) were partially alleviated.
ORR in the medium or bad IMDC risk group was 39.7% (95% CI, 28.0 to 52.3), of which 3 (4.4%) were fully mitigated and 24 (35.3%) were partially mitigated.
CPS in 52 patients ≥ 1,58 patients had CPS <1.
results expressed by PD-L1 showed that the ORR in the CPS≥1 group was 44.2% and the ORR in the CPS<1 group was 29.3% 30.0% of patients with treatment-related adverse events, the most common of which were colitis (5.5%) and diarrhea (3.6%).
three patients died from adverse events and one from treatment-related pneumonia.
Despite the inherent limitations of single-arm design, the results of this study show that Pabliju monotherapy has convincing anti-tumor activity, safe and long-lasting, for patients with advanced ccRCC (including all IMDC risk groups) and all patients with IMDC risk.
has the potential to become a treatment for patients with advanced ccRCC who are less resistant to other drugs.
these results support the further exploration of Pabliju monotherapy, complementary therapy, and this-based combined therapy in patients with late-stage or metastasis ccRCC.
: David F. McDermott, Jae-Lyun Lee, Georg A. Bjarnason, et al. Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma. February 02, 2021. DOI: 10.1200/JCO.20.02363 Journal of Clinical Oncology.MedSci Original Source: MedSci Original Copyright Notice: All Noted on this website Source: Met Medical Or "Source: MedSci Original" text, images and audio-visual materials, copyrights are owned by Metz Medicine, without authorization, no media, website or individual may reproduce, authorized to reproduce with the words "Source: Mets Medicine".
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