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R.D. Schouten
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MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M. Reck, D.R. Spigel
- Coordinates: 12/06/2016, 16:00 - 17:30, Strauss 2
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MA14.07 - Real Life Experience with Immunotherapy in the Netherlands (ID 4689)
16:42 - 16:48 | Author(s): R.D. Schouten
- Abstract
- Presentation
Background:
Randomized phase III trials have shown that the PD-1 blocking monoclonal antibody Nivolumab is effective in advanced NSCLC. Nivolumab is registered by the FDA and EMA for treatment of NSCLC. However, approval in The Netherlands was put on hold because of Nivolumab's high price per quality adjusted life year (QALY). From August 2015, Nivolumab was provided through a compassionate use program. Here we present our experience in treating NSCLC patients with Nivolumab in real life.
Methods:
Efficacy and safety of Nivolumab was assessed in patients with advanced NSCLC, previously treated with at least one line of platinum-based chemotherapy and an ECOG-PS of ≤2. Nivolumab was administered 2-weekly at a dose of 3 mg/kg intravenously. Response evaluation took place according to RECIST 1.1 at 12 and 24 weeks after start of treatment.
Results:
In the 10-month period in a single center 189 patients started treatment with Nivolumab, with a mean follow up time of 106 days after start of treatment. Mean age was 62 years (range 29–83), 57% male, 18,5% never smoked, 68% had adenocarcinoma, 20% had squamous histology and 12% were other, mixed or unspecified types. Figure 1 Twenty-four percent of patients experience immunotherapy related toxicity, most toxicities were short-term or easily manageable. No grade 5 toxicities, one grade 4 hepatitis and one grade 3 hypophysitis were observed. Hypothyroidism was most frequently observed (gr.1-2; 9,5%), followed by skin-reactions (gr.1-3; 3,8%) and colitis (gr.1-2; 3,2%). Other immune related toxicities were hepatitis (gr.1-4; 2,5%), infusion reactions (gr.1; 2,5%), pneumonitis (gr.2; 1,9%), hyperthyroidism (gr.1; 1,3%), arthritis (gr.2; 0,6%), hypophysitis (gr.3; 0,6%) and diabetes mellitus type 1 (gr.3, 0,6%).
Conclusion:
Although follow up is short and response data not yet mature, real-life efficacy and safety data from Nivolumab are comparable to phase III trial data.
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OA13 - Immunotherapy in Malignant Pleural Mesothelioma: Current Status of Trials and New Approaches (ID 392)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
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OA13.01 - A Phase II Study of Nivolumab in Malignant Pleural Mesothelioma (NivoMes): With Translational Research (TR) Biopies (Abstract under Embargo until December 6, 7:00 CET) (ID 3881)
14:20 - 14:30 | Author(s): R.D. Schouten
- Abstract
- Presentation
Background:
No studies have reported any survival benefit in recurrent MPM. We examined the effect of nivolumab, in patients who presented with progressive disease and agreed to have biopsies taken before and during treatment.
Methods:
In this single center, phase II study, patients received nivolumab (3mg/kg q2w) until progression or toxicity. The primary endpoint was an improvement of disease control rate at 12 weeks of 20 to >40% compared to historic control according to a Simon two-stage design. A total of 33 patients were planned with paired biopsies at week -1 and 6 according to treatment start. PD-L1 status and other biomarkers were analyzed.
Results:
From 09-2015 until 06-2016, 38 patients were included with 33 having paired biopsies; 4 were not evaluable. There were no treatment related death and DCR at 12 weeks was 50%. Five patients had a confirmed PR; 12 had SD and 17 PD. Three patients showed pseudo-progression. Grade 3 toxicity occurred in 8 patients leading to discontinuation of the treatment in 4. The table shows the patients/tumor details. PD-L1 ≥1% was expressed in 9/32 evaluable patients with 2/9 having a confirmed PR at 12 weeks.
Conclusion:
Nivolumab in 2[nd] or later lines in recurrent MPM met the primary endpoint. The toxicity was mild and long lasting results were observed. A clear correlation between PD-L1 expression and response was obeserved.Outcome Age mean 66 yrs (51-81) M/F 28 / 6 Epithelial/mixed/non epithelial 28 / 4 / 2 PR/SD/PD 5 / 12 / 17 PD-L1 + (1-10; 10-25; 25-50; >50%) 2 / 1 / 3 / 3 Correlation PR/SD/PD according to PD-L1 expression <1% : 3/8/12 1 - 10% : 0/1/1 10-25% : 0/0/1 25-50% : 1/1/1 > 50% : 1/1/1 Correlation PR/SD/PD with histology Epithelioid : 4/9/15 Mixed : 1/2/1 Non-epithelial : 0/1/1
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