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Ioannis Stylianou



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-12 - SWItch Maintenance PEmbrolizumab in Patients with Metastatic Non Small Cell Lung Cancer (SWIPE) (ID 14151)

      16:45 - 18:00  |  Author(s): Ioannis Stylianou

      • Abstract
      • Slides

      Background

      Pembrolizumab is currently indicated for first line use for patients with >50% PD-L1 overexpression and for pretreated patients with >1% PD-L1 expression with metastatic Non Small Cell Lung Cancer (NSCLC). There are currently no data for its use as maintenance treatment. SWIPE is a prospective single arm, one stage Phase II study offering Pembrolizumab as maintenance therapy to non-progressors after first line palliative chemotherapy with NSCLC. (NCT 02705820)

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Standard inclusion and exclusion criteria for checkpoint inhibitors studies apply, however also patients with WHO Performance Status (PS) 2 were allowed and there was no restriction on PD-L1 expression. Treatment consisted of Pembrolizumab 200 mg fixed dose every 3 weeks. Radiological assessement with CT scans every 9 weeks in the first year. The study employs a one stage phase II Fleming's design using Immune Related (IR) Progression Free Survival (PFS) at 1 year as primary endpoint. Using response hypotheses of H0 < 12 % and Ha> 25%, with a significance level α=0.05 and power 0.8, 48 patients are required to be entered into this study.

      4c3880bb027f159e801041b1021e88e8 Result

      Thirty-six (36) patients have been enrolled so far. 29 patients have more than 6 months follow up data, and are the subjects of this analysis. 23 males and 6 female patients. Median age 65 years (range 40-82). PS WHO 0 for 12 patients, WHO 1 for 15 patients and WHO 2 for 2 patients. Histology: adenocarcinoma in 22 patients and squamous in 7 patients. In terms of best radiological response 2 patients had a partial response and 13 patients stable disease. Median IR PFS is 6.8 months (CI 4.0-17.2). The 6 month and 1 year IR PFS rate is 60.7% and 45.8%. Median OS is 11.3 months (CI 7.4-15.2). The 6 month and 1 year OS rate is 65.5% and 48.0% (SPSS version 23). Toxicity was mainly grade 1-2; commonest being fatigue 18 patients (62%), anorexia, arthralgia and cough 10 patients (34%). One patient developed diabetes mellitus (grade 3) as auto-immune toxicity. Three (3) patients developed grade 3 dyspnoea, none of which were related to Pembrolizumab. There was one death during treatment due to sepsis, unlikely to be related to Pembrolizumab.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Maintenance Pembrolizumab is associated with a clinically meaningful disease control rate of almost 46% at 1 year with manageable toxicity.

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