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Ardaman Shergill



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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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      P1.01-86 - BTCRC-LUN15-017: Phase-Ib Study of Imprime PGG and Pembrolizumab in Stage IV NSCLC after Progression on Platinum Based Therapy (ID 12794)

      16:45 - 18:00  |  Presenting Author(s): Ardaman Shergill

      • Abstract
      • Slides

      Background

      Imprime PGG (Imprime) is a β-glucan isolated from a proprietary strain of Saccharomyces cerevisiae. It acts as pathogen associated molecular pattern, creating ‘non-self’ signals, enhancing innate immune cell killing, and possibly T-cell cross-talk, thereby enhancing efficacy of checkpoint inhibitor therapy like pembrolizumab. Clinical use of Imprime in combination with chemotherapy and monoclonal-antibodies has been reported, however no studies to date have evaluated its use with anti-PD-1 therapy. We aimed to evaluate safety and tolerability of Imprime with pembrolizumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a single-arm, phase-1b, open-label, dose-escalation trial for patients with stage IV NSCLC after progression on platinum-based chemotherapy. Key eligibility included measurable disease, adequate organ function and ECOG performance status of 0-2. Patients received 2 mg/kg or 4 mg/kg IV Imprime on day 1, 8, 15, and 200mg IV pembrolizumab on day 1, every 21 days. “3+3” design was used to establish highest tolerated dose. The dose with toxicity rate of <33% in first cycle would be considered the recommended phase-II dose i.e.≤1 out of 6 patients experience dose limiting toxicity (DLT). Primary endpoint was to establish highest tolerated dose of Imprime for recommendation for phase-II study. Secondary objectives were to define safety and tolerability, and to correlate clinical benefit with biomarkers on immune cells, soluble PD-L1 levels, anti-β-glucan antibody and FcγRIIa polymorphism. This trial is registered with ClinicalTrials.gov, NCT03003468.

      4c3880bb027f159e801041b1021e88e8 Result

      Between 07/2017-02/2018, nine patients were enrolled: three patients received 2 mg/kg and six received 4 mg/kg dose of Imprime. Eight out of nine patients had one line of treatment prior to participation, and one had two lines. Two patients received eleven cycles with 4 mg/kg Imprime. To date, no DLTs have been recorded and the highest dose of Imprime was well tolerated. Five patients stopped treatment due to progression. Four patients are continuing treatment. No patients stopped treatment due to toxicity. Most common adverse event (AE) at 2 mg/kg was grade 1 sore throat in two patients. One Grade 3 diarrhea and one grade 3 neutropenia were reported. Most common AE in the 4 mg/kg group was grade 1 headache in three patients. One episode of grade 3 diarrhea was reported. There were no grade 4 or 5 toxicities. The results of the immunopharmacodynamic analysis will be reported when available.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Imprime in combination with pembrolizumab is well tolerated in outpatient settings and the role of this combination in treatment of NSCLC warrants further investigation. Phase-II enrollment of this trial is ongoing.

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