Mocht u kanker-actueel de moeite waard vinden en ons willen ondersteunen om kanker-actueel online te houden dan kunt u ons machtigen voor een periodieke donatie via donaties: https://kanker-actueel.nl/NL/donaties.html of doneer al of niet anoniem op - rekeningnummer NL79 RABO 0372931138 t.n.v. Stichting Gezondheid Actueel in Amersfoort. Onze IBANcode is NL79 RABO 0372 9311 38   
Elk bedrag is welkom. En we zijn een ANBI instelling dus uw donatie of gift is in principe aftrekbaar voor de belasting. En als donateur kunt u ook korting krijgen bij verschillende bedrijven: 

https://kanker-actueel.nl/NL/voordelen-van-ops-lidmaatschap-op-een-rijtje-gezet-inclusief-hoe-het-kookboek-en-de-recepten-op-basis-van-uitgangspunten-van-houtsmullerdieet-te-downloaden-enof-in-te-zien.html

8 augustus 2016: lees ook dit artikel: 

https://kanker-actueel.nl/NL/immuuntherapie-met-bacterie-naast-chemo-zorgt-voor-zeer-goede-resultaten-bij-inoperabele-mesothelioma-met-ziektecontrole-van-90-procent.html

8 augustus 2016: Bron:

Immuuntherapie met nivolumab (Opvido) bij nog niet behandelde longkankerpatienten of eerste recidief van longkanker (Checkmate studie 026) geeft in vergelijking met chemo (voor plaveiselcarcinomen of Carboplatin/Gemcitabine of Carboplatin /Paclitaxel of Cisplatin/Gemcitabine) of voor niet plaveisel carcinomen (Carboplatin/Pemetrexed of Cisplatin/Pemetrexed) geen statistisch significant verschil in overall overleving en ziektevrije tijd. Zo meldt de producent van nivolumab (opvido) in een persbericht.

Echter er worden nog geen gedetailleerde studieresultaten gegeven dus is het niet mogelijk te controleren waar wel verschil in zit of dat bv. er wel een klein verschil is maar niet statistisch significant. Of dat wellicht de bijwerkingen anders liggen, of dat de resultaten voor alle chemo combinaties gelden enz.

Hier staat summier het studieprotocol zoals dat in Nederland gehanteerd wordt in o.a. het UMCG - Groningen: 

https://www.dagcentrumgroningen.nl/tlbs/download/5610

Ik kan eigenlijk ook alleen maar het persbericht geven. Hopelijk later meer informatie over deze studieresultaten.

nivolumab medicijn etiket

Hier het persbericht:

Opdivo (nivolumab) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5%.

Source: Bristol-Myers Squibb

Bristol-Myers Squibb Announces Top-Line Results from CheckMate -026, a Phase 3 Study of Opdivo (nivolumab) in Treatment-Naïve Patients with Advanced Non-Small Cell Lung Cancer

Opdivo did not meet trial primary endpoint of progression-free survival in patients expressing PD-L1 ≥ 5%

Friday, August 5, 2016 8:20 am EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that CheckMate -026, a trial investigating the use of Opdivo (nivolumab) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5%. The company will complete a full evaluation of the CheckMate -026 data and work with investigators on the future presentation of the results.

Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb, commented, “Opdivo has become a foundational treatment that is transforming cancer care across multiple tumor types. While we are disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate -227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”

About CheckMate -026

CheckMate -026 is a Phase 3, open-label, randomized study of Opdivo as monotherapy versus investigator’s choice chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Patients enrolled in the trial had received no prior systemic treatment for advanced disease and tested positive for PD-L1 expression. The trial randomized 541 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or investigator’s choice chemotherapy in squamous patients (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and non-squamous patients (pemetrexed with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completion of 6 cycles. The primary endpoint is progression-free survival, as assessed by the Independent Radiology Review Committee, in patients with ≥ 5% PD-L1 tumor expression.  

Bristol-Myers Squibb Statement on Top-Line Results from CheckMate -026

Friday, August 5, 2016 8:22 am EDT

While today’s news regarding CheckMate -026 is disappointing, Bristol-Myers Squibb is proud of all that the company has and aims to accomplish with Opdivo. We are indeed transforming cancer care, and remain committed to bringing the benefit of our medicines to the greatest number of patients across multiple cancers.   

We designed our development program in lung cancer to address the unmet need of every lung cancer patient and our scientific approach is a bold one. Our first-line strategy consists of two trials – one that is studying Opdivo alone and one studying Opdivo in combination with Yervoy.

  • CheckMate -026 was designed to answer the question of the benefit of Opdivo monotherapy in a broad patient population.  Unfortunately, this trial did not meet its primary endpoint of progression-free survival in patients whose tumors expressed PD-L1 at ≥ 5%. 
  • CheckMate -227 is an ongoing study exploring the potential of the combination of Opdivo plus Yervoy for PDL-1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.

We believe that combination therapy may provide an important opportunity to address the needs of every patient with first-line lung cancer.

Everyone at Bristol-Myers Squibb is relentless in our pursuit to defeat cancer and bring transformational medicines to patients who are waiting. 

U.S. FDA APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post- transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please refer to the end of the Important Safety Information for a brief description of the patient populations studied in the CheckMate trials.


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