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Jose Manuel Trigo



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    P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.04-24 - Nivolumab in the "Real World": Are the Results of Clinical Trials Reproducible? (ID 12404)

      16:45 - 18:00  |  Author(s): Jose Manuel Trigo

      • Abstract
      • Slides

      Background

      It have passed more than two years since the approval of nivolumab in the second or third lines of treatment of non-small cell lung cancer (NSCLC) in advanced or recurrent stages, so that we know the results in patients in our area.
      The main objective of this study is to analyze the results in a "real" population of different hospitals in Spain since we will be able to compare our results with the once published previously.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We have reviewed 129 patients with NSCLC, advanced or recurrent stages, treated with nivolCutumab either in second and subsequent lines of treatment, after progression to a platinum-based scheme from its expanded use until April 2018, in five hospitals in Spain.

      The information was collected retrospectively of clinical, analytical, pathological and treatment characteristics of the patients. Statistical analysis was performed using the SPSS software vs 21.0, considering the statistical significance if p <0.05

      4c3880bb027f159e801041b1021e88e8 Result

      With a median follow-up of 6 months (0-31), the overall survival (OS) was 9 months (5.86-12.14).

      Patients with ECOG 0-1 presented a median OS of 11 months compared to 3 months of median OS in patients with ECOG 2 (p: 0.001)

      If the response to previous treatment was complete response, partial response or stabilization of the disease, they will have a median OS of 12 months compared to 6 months if the best response was progression (p: 0.002).

      There is also a statistically significant difference in terms of overall survival in relation to the existence of toxicity for immunotherapy or not (median of 13 versus 6 months p: 0.004).

      The overall survival of patients who had progressed beyond 6 months after the start of treatment with prior chemotherapy was significantly greater than patients who had progressed in the first 6 months after the start of chemotherapy (median of 4 months versus median of 13 months, p: 0.001)

      8eea62084ca7e541d918e823422bd82e Conclusion

      Immunotherapy has come to stay taking part of the usual clinical practice of patients with lung cancer. The results obtained in our population are comparable to those previously published, with an important group of patients that responded to immunotherapy or stabilized even for a long time. However, we highlight that also there is a percentage of patients, who progress early. We see fundamental to find or recognize, not just the ideal biomarker that helps to predict response, but those clinical characteristics that can make us presage a poor result.

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      P2.04-27 - Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC (ID 14307)

      16:45 - 18:00  |  Author(s): Jose Manuel Trigo

      • Abstract

      Background

      Bemcentinib (BGB324) is a first-in-class, highly selective oral inhibitor of the AXL tyrosine kinase currently in phase II clinical development across several cancer types. AXL overexpression has been observed in pts failing anti-PD-1 therapy in several cancers whereas AXL inhibition via bemcentinib has shown synergistic effect with checkpoint blockade in pre-clinical models of NSCLC.

      In pts with advanced, pre-treated NSCLC, bemcentinib monotherapy led to disease stabilisation in 2 out of 8 pts including evidence of tumour reduction. Combination therapy of bemcentinib with EGFR inhibition indicated the potential of AXL blockade to reverse resistance to targeted therapy in advanced EGFR therapy resistant NSCLC. Evidence of immune activation following bemcentinib monotherapy was observed in AML patients.

      This open label, single-arm, two-stage Phase 2 study was designed to test whether AXL inhibition may increase the efficacy of pembrolizumab in patients with advanced, previously treated adenocarcinoma of the lung.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with documented Stage IV adenocarcinoma of the lung who had progressed on previous platinum chemotherapy and – if applicable – at least one line of licensed EGFR or ALK targeted therapy, received 200 mg/d bemcentinib po and 200 mg/q3wk pembrolizumab iv. Patients were required to consent to a fresh pre-treatment biopsy. Tumour assessments were done 9-weekly. The primary endpoint was ORR. Tumour biopsies were analysed for PD-L1 and AXL as well as immune cell populations. Plasma protein biomarker levels were measured using the DiscoveryMap v3.3 panel (Myriad RBM) in patients pre-dose and at C2D1.

      4c3880bb027f159e801041b1021e88e8 Result

      As of time of writing, the study had fully recruited its first stage. Of 24 patients enrolled, 14 were ongoing. 6 of 10 patients who had reached their first scan showed evidence of tumour shrinkage including 3 pts with partial responses in their target lesions. 2 patients had stable disease. There were no grade 4 treatment-related events. Dose reduction from 200 to 100 mg/d of bemcentinib as a consequence of adverse events was required in 12% of patients. Correlation of AXL and PD-L1 expression with response was evaluated. Soluble AXL plasma levels were increased following one cycle of treatment indicative of target engagement.

      8eea62084ca7e541d918e823422bd82e Conclusion

      A preliminary analysis of response to combination treatment during the first stage of this study as well as biomarker correlation will be presented at the meeting. Clinical trial information: NCT03184571

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