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John Wrangle



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    P77 - Immunotherapy (Phase II/III Trials) - Combining Different Immunotherapeutic Approaches (ID 254)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P77.01 - Preliminary Data from QUILT 3.055: A Phase 2 Multi-Cohort Study of N803 (IL-15 Superagonist) in Combination with Checkpoint Inhibitors in NSCLC (ID 3797)

      00:00 - 00:00  |  Presenting Author(s): John Wrangle

      • Abstract
      • Slides

      Introduction

      A majority of NSCLC patients treated with checkpoint inhibitors will experience progression of their disease at some point. There is currently a paucity of treatment options for checkpoint relapsed patients who have had an initial response but subsequently progress. Many trials focus on a second checkpoint target (IDO, TIM3, LAG3, TIGIT) to overcome this resistance. N803, a novel IgG1 Fc-engineered IL-15-complexed protein may rescue checkpoint activity through a checkpoint independent manner via its selective enhancement of natural killer cell (NK) and CD8+ T cell number and function, without stimulation of T regs and MDSCs.

      Methods

      QUILT 3.055 (NCT03228667) is an ongoing phase 2b study of N803 in combination with investigator choice checkpoint inhibitor in multiple tumor types with a heterogeneous mix of prior therapies. We present interim data for 70 patients with 2nd and 3rd line NSCLC treated with a checkpoint inhibitor alone or in combination with chemotherapy as their most recent prior therapy. Trial inclusion required investigator assessed progression on their last line of therapy for study entry. Subjects received N803 15mck/kg SC every 3 weeks in combination with the same checkpoint inhibitor on which they had their most recent progression. Study entry required that patients had either CR with relapse or partial response or stable disease for 6 months with progression as their most recent result of checkpoint therapy. Patients with hyperprogression or best initial response of progression were excluded.

      Results

      Preliminary data from 70 NSCLC patients with either 2nd or 3rd line treatment with checkpoint and N-803 following progression on the same checkpoint are shown in the figure below. Response data is as follows: 3% partial response (PR), 59% stable disease (SD), 30% progressive disease (PD), 6% no response assessment to date. N-803 is well tolerated with grade 1-2 common adverse events were injection site reaction (68%), nausea (41%) fatigue (38%), pyrexia (22%) but no individual grade 3 AEs were greater than 5%.

      3.055 spider plot.jpg

      Conclusion

      N803 demonstrates low toxicity in patients previously treated with checkpoint inhibitors and promising efficacy of reversal of progression and induction of durable stable disease, without interval chemotherapy or radiation, in NSCLC patients who had previously progressed on a checkpoint inhibitor containing regimen.

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