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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Bladder Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab vs placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma (MIUC).
Published date:
02/08/2021
Excerpt:
...multicenter trial of NIVO vs PBO in pts with high-risk MIUC (bladder, ureter, or renal pelvis)...In total, 353 pts were randomized to NIVO (PD-L1 ≥ 1%, n = 140) and 356 pts to PBO (PD-L1 ≥ 1%, n = 142). The primary endpoint of DFS was met in ITT pts (median follow-up, 20.9 mo for NIVO; 19.5 mo for PBO) and in pts with PD-L1 ≥ 1%. DFS and NUTRFS were improved with NIVO vs PBO in both populations...NIVO demonstrated a statistically significant and clinically meaningful improvement in DFS vs PBO for MIUC after radical surgery, both in ITT pts and pts with PD-L1 ≥ 1%.
DOI:
10.1200/JCO.2021.39.6_suppl.391
Trial ID:
Title:
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.
Source:
Title:
Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
Excerpt:
...Median Disease Free Survival by PD-L1 expression.`...
Trial ID:
Source:
Title:
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Excerpt:
...BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. ...
Trial ID:
More C2 evidence
Source:
Title:
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Excerpt:
...Disease Free Survival (DFS)`Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population...
Trial ID:
Source:
Title:
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo
Excerpt:
...Overall Response Rate (ORR)`Metastasis-free Survival (MFS)`Overall Survival (OS)`Quality of Life (QOL) and Bladder Functioning Questionnaires Assessment`PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC)`Th1/Th2 Cytokine Ratio Analysis...
Trial ID:
Less C2 evidence
Source:
Title:
Phase II trial of Concurrent Nivolumab and Radiation therapy in Elderly or Chemotherapy ineligible Muscle Invasive Bladder Cancer
Published date:
11/18/2023
Excerpt:
In conclusion, concurrent nivolumab and radiation therapy is tolerable but demonstrated limited efficacy in an elderly population with multiple comorbidities. Immune correlates demonstrated that patients with baseline PD-L1 combined prognostic score (CPS) ≥5% had numerically longer PFS.
DOI:
https://doi.org/10.1016/j.ijrobp.2023.11.024
