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Gilles Robinet



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    MA14 - The Adequate MTarget Is Still the Issue (ID 140)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA14.06 - Nintedanib-Docetaxel in 2nd Line Treatment in No Squamous Non-Small Cell Lung Cancer Patients, Refractory to First Line Treatment (GFPC02-15) (Now Available) (ID 558)

      15:45 - 17:15  |  Author(s): Gilles Robinet

      • Abstract
      • Presentation
      • Slides

      Background

      Second line chemotherapy used in advanced Non Small Cell Lung Cancer (NSCLC) have demonstrated a slight survival benefit in patient refractory to a first line platinum based doublet chemotherapy. In exploratory analysis, Nintedanib in combination with docetaxel have shown interesting result in second line setting for refractory NSCLC patients.

      Objective: To assess the efficacy in terms of progression-free survival (PFS) of the nintedanib - docetaxel combination in second-line treatment in refractory no squamous NSCLC (NsqNSCL) patients

      Method

      This prospective, multicentric open-label phase II trial, included patients with advanced Nsq NSCLC (EGFR, ALK wild-type), PS 0-1, progressing during the first four cycles of cisplatin-based induction chemotherapy. Patients received Nintedanib (200 mg X2 /d d2-d20)- Docetaxel (75 mg/m2 d1-d21) combination until progressive disease or unacceptable toxicity.

      The primary endpoint was the PFS rate at 12 weeks. Secondary endpoints included median PFS, median overall survival (OS), overall response rate (ORR) and tolerability. Based on a A’Hern’s single-stage phase II design trial (sample size determination is based on exact binomial distribution), the Nintedanib-Docetaxel strategy will be rejected if the primary endpoint was below 22/53 patients at the end of study.

      Result

      The analysis included 53 evaluable patients managed in 21 centers; last patient included at the end of January 2019. Mean age 58.4 years, male 73 %, adenocarcinoma 97.5%, current/former smokers: 42/50 %, PS 0/1: 25%/75%; weight loss >5% : 19%, stage IV: 100% (38% with brain metastasis, median metastasis 2). All patients received for induction chemotherapy, a platin doublet (22% with bevacizumab), number of cycle 1-2/ 3-4: 57%/ 43%.

      Interim analysis reviewed by the independent committee conducted as planned, after the 27 first inclusions concluded that there was no sign of unexpected toxicity (adverse events grade 3-4 :22%, grade 5 :0%) or futility (9 patients meet primary end point on 25 evaluable). The results of the final analysis on the whole population (PFS at 12 weeks (primary end point), median PFS, median OS and toxicity) will be presented at the meeting

      Academic grant from Boehringer Ingelheim

      Conclusion

      Section not applicable

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-09 - VinMetAtezo: Phase II Trial of Metronomic Oral Vinorelbine with Atezolizumab for Recurrent Stage IV NSCLC (GFPC*04-08) (ID 690)

      10:15 - 18:15  |  Author(s): Gilles Robinet

      • Abstract
      • Slides

      Background

      Immunotherapy is recommended as second-line treatment for advanced Non-Small Cell Lung Cancer (NSCLC) progressing after a platinum doublet treatment. However, response rates remain low and some patients have rapid progression. Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently. Metronomic oral vinorelbine (MOV) is defined as low-dose and frequent chemotherapy administration. There is no data of the association of immunotherapy and metronomic chemotherapy. The main objective of this trial was to assess safety and efficacy of this combination of MVO and atezolizumab.

      Method

      An open label phase 2 trial (NCT 03801304) in two steps.

      -First step: a safety run-in phase: 12 patients will be enrolled and will receive atezolizumab in combination with MOV (40 mg/day 3 times a week, every week). After 12 patients have received study treatment and completed at least 1 cycle of study treatment (21 days), enrollment will be interrupted and an independent Data Safety Monitoring Board (DSMB) will review the number and percentage of adverse events (AEs). The dose will be considered toxic when Grade ≥ 3 immune-related AEs (>20%) or vinorelbine-related AEs (>20%) occurs. In this case the dose will be decreased to 30 mg, 3 times a week. AEs will be assessed with the same procedure that will be applied to the next 12 patients.

      - Second step: phase II design as defined by A’hern. The main outcome is PFS rate at 4 months. Minimal efficacy hypothesis (p1) is set at 55% event-free rate of PFS at 4 months, (p0), which would indicate that the strategy is clearly ineffective, is set at 40% PFS at 4 months. With a 5% alpha risk (unilateral perspective) and a 20% beta risk, the number of assessable subjects is set at 71.

      Result

      The trial started on 2019 January 24th. 12 patients have been included in 4 centers. The run in step ended at the beginning of April, with no grade 3 or more immune related AEs or vinorelbine related AEs. The DSMB decided to expand the study to the second step, which will start on April, 17th.

      Conclusion

      Combination of atezolizumab and MOV appears as a feasible association without major toxicities. The phase 2 is ongoing; complementary results on safety and efficacy will be presented at the meeting.

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