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Paboli juju monotherapy provides long-lasting anti-tumor activity (ORR - 26.7%) in patients with untreated advanced non-transparent cellular kidney cancer (nccRCC), which may be a potential treatment option for nccRCC.
has not yet conducted a prospective evaluation of PD-1 pathway inhibitors in nccRCC patients.
this, the team conducted a KEYNOTE-427 Phase II study to assess the efficacy and safety of the PD-1 inhibitor Pabli juju monodruplitic therapy in late nccRCC.
February 2, Journal of Clinical Oncology released the results of the single-arm, open-label, multi-queue, multi-center Phase II clinical trial of the Paboli Juju mono-anti-first-line treatment nccRCC.
the study included 165 patients with nccRCC who met conditions that were histologically confirmed, measurable, and had not previously been treated with metastasis systemic systems.
of the 165 patients in the group, 71.5% were papicellular cancer, 12.7% were color cell carcinomas, and 15.8% of RCC histology had not been classified.
According to the International Alliance Risk Classification (IMDC) of the Metastatic Kidney Cancer Database, the team classified 53 patients (32.1%) and 112 patients (67.9%) as good, moderate or poor.
PD-L1 combined positive score (CPS) for the majority of patients (61.8%) ≥1.
the average time from the group to the database deadline is 31.5 months (range 22.7-38.8).
PFS for the entire nccRCC group was 4.2 months (95% CI, 2.9-5.6), and 24.7% and 18.6% for 12 and 24 months, respectively.
OS for 28.9 months (95% CI, 24.3 months - not achieved), 73.2% for 12 months and 58.4% for 24 months.
orR for the total population was 26.7%.
results of PD-L1 expression showed that for patients with CPS≥1 (n s 102), the ORR was determined to be 35.3% (95% CI, 26.1 to 45.4).
for patients with CPS -lt;1 (n s 58), the confirmed ORR was 12.1% (95% CI, 5.0 to 23.3).
results of histology showed that ORR in papicellular cancer group, suspected cell carcinoma group and unclassified group was 28.8% (95% CI, 20.8% to 37.9%) respectively. 9.5% (95% CI, 1.2% to 30.4%) and 30.8% (95% CI, 14.3% to 51.8%, respectively).
results from the IMDC risk category showed that for patients at good IMDC risk (n s 53), the orR diagnosed was 32.1% (95% CI, 19.9% to 46.3%).
in the moderate or adverse IMDC risk subgroup (n s 112), the confirmed ORR was 24.1% (95% CI, 16.5% to 33.1%).
in terms of safety, 69.7% of patients experienced treatment-related adverse events, with the highest rate of itching (20.0%) and hypothyroidation (14.5%).
addition, two treatment-related deaths were reported.
Paboliju monotherapy showed good anti-tumor activity and survival rates in late-stage or metastasis nccRCC first-line therapy, and its safety characteristics were similar to those observed in other tumor types.
The objective mitigation rate of
Paboliju monodrug therapy reached 26.7% in the entire nccRCC population, consistent in key subgroups including patients with different histological subtypes and tumor patients with highly programmed death lipotherapy1.
but current research has some limitations.
, the one-arm study design limits the comparison of reaction rate and survival results with the current recommended scheme.
, the heterogeneity of the nccRCC patient population makes it difficult for subgroup analysis to determine which patients are getting the most benefit.
, despite central pathology tests, the team was unable to subdivide patients into type I and type II papyroids.
in summary, Pabliju monotherapy showed promising anti-tumor activity and survival rates in nccRCC patients, with similar safety and tolerance as observed in other tumor types.
given the lack of established therapies for nccRCC and the advantages of ORR over VEGF and mTOR therapies, Pabliju monodring therapy may be a potential treatment option for nccRCC.
: Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. David F. McDermott, Jae-Lyun Lee, Marek Ziobro, Cristina Suarez, Przemyslaw Langiewicz, Vsevolod Borisovich Matveev, Pawel Wiechno, Rustem Airatovich Gafanov, Piotr Tomczak, Frederic Pouliot, Frede Donskov, Boris Yakovlevich Alekseev, Sang Joon Shin, Georg A. Bjarnason, Daniel Castellano, Rachel Kloss Silverman, Rodolfo F. Perini, Charles Schloss, and Michael B. Atkins. Journal of Clinical Oncology 0 0:0 Ning Xianxuan Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Mets Medicine and are not reproduced by any media, website or individual authorized to reproduce.
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