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10 mei 2017: Bron: FDA

Immuuntherapie met avelumab, een anti-PD medicijn, heeft van de FDA versnelde toelating gekregen voor gebruik bij gevorderde urineleiderkanker - blaaskanker stadium 4, nadat tijdens een tussenevaluatie uit een fase III studie: de phase III JAVELIN Bladder 100 trial  goede resultaten werden gezien in progressievrije ziekte en overall overleving.

Overall response rate (ORR) bij patiënten (N = 242) met gevorderde urineleiderkanker die op z'n minst 13 weken de behandeling hebben gevolgd was  13.3% (n=30) (95% CI: 9.1, 18.4) en 16.1% (n=26) (95% CI: 10.8, 22.8) na een half jaar gebruik. Mediane tijd tot er een meetbare reactie werd gezien was 2.0 maanden (range 1.3-11.0). De mediane response duur is nog niet bereikt voor de patienten die minimaal 13 weken werden behandeld en / of die minimaal een half jaar werden behandeld. Tot nu toe bedraagt die (range: 1.4+ tot 17.4+ maanden in beide groepen.

Ik vertaal de resultaten nu niet verder in het Nederlands maar bekijk hieronder de grafieken en lees de FDA toelating die m.i. duidelijk genoeg zijn. Of gebruik de vertaaltool van google rechtsboven dit artikel.

Of bekijk deze andere studie met avelumab bij blaaskanker en urineleiderkanker: Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study

Avelumab bij blaaskanker en urineleiderkanker OS

Hier de grafiek van de resultaten: (tekst loopt verder onder grafiek)

Avelumab bij blaaskanker en urineleiderkanker

Het volledige studierapport: Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. is gratis in te zien.

Onderaan het abstract van de studie plus referentielijst

Hier de FDA toelating voor Aveluma:

FDA grants accelerated approval to avelumab for urothelial carcinoma

On May 9, 2017, the U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Approval was based on data from an open-label, single arm, multi-center study that enrolled 242 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based therapy or within 12 months of a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. Patients received avelumab, 10 mg/kg intravenously, every 2 weeks until radiographic or clinical progression or unacceptable toxicity. All patients received pre-medication with an anti-histamine and acetaminophen prior to each avelumab administration. Confirmed overall response rate (ORR) in patients who had been followed for at least 13 weeks was 13.3% (n=30) (95% CI: 9.1, 18.4), and 16.1% (n=26) (95% CI: 10.8, 22.8) in patients who had been followed for at least 6 months. Median time to response was 2.0 months (range 1.3-11.0). The median response duration had not been reached in patients followed for at least 13 weeks or at least 6 months, but ranged from 1.4+ to 17.4+ months in both groups.

Reed more>>>>>>>>>>>>>>>

Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic Urothelial carcinoma of the bladder

DOI: 10.1200/JCO.2016.71.6795 Journal of Clinical Oncology - published online before print April 4, 2017

Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study

, , , , , , , , , , , , , , , , and

Abstract

We assessed the safety and antitumor activity of avelumab, a fully human anti–programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma.

In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors version 1.1), progression-free survival, overall survival (OS), and PD-L1–associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells.

Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1–positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%).

Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC.

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