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Rosalyn J. Juergens



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    OA 17 - Immunotherapy II (ID 683)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      OA 17.03 - First-Line Nivolumab plus Platinum-Based Doublet Chemotherapy for Advanced NSCLC: CheckMate 012 3-Year Update (ID 9043)

      14:30 - 16:15  |  Presenting Author(s): Rosalyn J. Juergens

      • Abstract
      • Presentation
      • Slides

      Background:
      Platinum-based doublet chemotherapy is the standard-of-care first-line treatment for most patients with advanced NSCLC, but responses are not durable (~4.5–6 mo). Chemotherapy may sensitize NSCLC tumors to immune checkpoint inhibitors. Nivolumab, a fully human programmed death (PD)-1 antibody, demonstrated long-term survival benefit in patients with previously treated advanced NSCLC. Here we report the 3-year update of safety and efficacy of first-line nivolumab combined with chemotherapy in the phase 1 CheckMate 012 study (NCT01454102).

      Method:
      Chemotherapy-naïve patients with stage IIIB/IV NSCLC were randomly assigned based on histology in 3 cohorts combining nivolumab Q3W with 3 platinum-based doublet chemotherapy regimens: nivolumab 10 mg/kg + gemcitabine-cisplatin (all squamous histology), nivolumab 10 mg/kg + pemetrexed-cisplatin (all non-squamous), and nivolumab 10 mg/kg or 5 mg/kg + paclitaxel-carboplatin (any histology). After 4 cycles of nivolumab plus chemotherapy, patients received nivolumab monotherapy until progression or unacceptable toxicity. The primary objective was safety. ORR, PFS, and OS were secondary/exploratory endpoints.

      Result:
      56 patients were treated. Median age was 63.5 years, 46% were male, and 14% were never-smokers; 29% of tumors had squamous histology. At database lock (September 19, 2016) the minimum follow-up was 45.5 mo. Median duration of chemotherapy treatment was ~12 weeks (4 cycles; range: 3–18 weeks) and median duration of nivolumab treatment was 17–22 weeks across cohorts (range: 3–204). No new safety signals were observed in patients receiving nivolumab maintenance compared with the September 2014 database lock. ORR was 46%. Median duration of response was 10.4 mo (95% CI: 5.1, 26.3). Median PFS was 6.0 mo (95% CI: 4.8, 8.3). Median OS was 19.2 mo (95% CI: 14.1, 23.8), and the 3-year OS rate was 25%. ORR and OS were similar in patients with tumor PD-L1 expression <1% (n=23) vs ≥1% (n=23): ORR 48% vs 52%; median OS 19.2 mo (95% CI: 12.2, 23.8) vs 20.2 mo (95% CI: 10.9, 27.2). The 3-year OS rate was 22% in both PD-L1 expression subgroups.

      Conclusion:
      Nivolumab plus chemotherapy resulted in prolonged survival in a subset of patients, with a 3-year OS rate of 25%. In all patients, ORR and OS were similar irrespective of tumor PD-L1 expression. These results support further evaluation of nivolumab-chemotherapy combinations as first-line treatment for advanced NSCLC, which are being explored in CheckMate 227 (NCT02477826).

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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-029 - CheckMate 169: Safety/Efficacy of Nivolumab in Canadian Pretreated Advanced NSCLC (including Elderly and PS 2) Patients (ID 9042)

      09:30 - 16:00  |  Presenting Author(s): Rosalyn J. Juergens

      • Abstract
      • Slides

      Background:
      Nivolumab demonstrated efficacy and safety in patients with previously treated advanced/metastatic NSCLC in the two phase 3 trials CheckMate 017 and 057 (median OS, 9.2–12.2 months; 1-year OS rate, 42–51%; 2-year OS rate, 23–29%; any-grade treatment-related AEs [TRAEs], 68%; grade 3–4 TRAEs, 10%). As patients with ECOG PS 2 were excluded from these phase 3 trials, there is limited evidence for nivolumab efficacy in this patient subgroup. CheckMate 169 (NCT02475382) is an expanded access program (EAP) of nivolumab in patients with advanced NSCLC and disease progression after ≥1 prior systemic therapy; efficacy/safety results from the Canadian cohort are presented here.

      Method:
      Eligible patients were aged ≥18 years with relapsed stage IIIb/IV NSCLC and an ECOG PS of 0–2 who had received ≥1 prior platinum-containing therapy. Patients with carcinomatous meningitis or untreated brain metastases were excluded. Nivolumab (3 mg/kg IV Q2W) was administered until disease progression or unacceptable toxicity for a maximum of 2 years. In addition to providing nivolumab to patients, the primary objective was to assess safety and OS. Outcomes in specific patient subgroups, including elderly patients (aged ≥70 years) and those with poor performance status (PS 2), were assessed in post hoc analyses.

      Result:
      Of 161 patients treated in Canada, 53% were male, 94% were current/former smokers, 32% had squamous NSCLC, and 43% had received ≥2 prior therapies. 30% were aged ≥70 years and 19% had an ECOG PS of 2. At the time of analysis, 76% of patients had discontinued treatment. Nivolumab was well tolerated. In the overall population, TRAEs of any grade were reported in 69% of patients, with grade 3 or 4 events in 14%; no TR deaths occurred. 9% of patients discontinued due to TRAEs. The safety profile of nivolumab in patient subgroups (age ≥70 years and PS 2) was similar to the overall population. The median OS (95% CI) in the overall population was 9.1 months (7.5, 14.4), with a 1-year OS rate of 44%. The median OS was 8.0 months (5.3, 12.9) for elderly patients and 5.9 months (3.6, 7.9) for those with PS 2. The presentation will include patient case studies from the subgroups.

      Conclusion:
      In this EAP of nivolumab in Canadian patients with previously treated NSCLC, safety and OS were consistent with observations from prior controlled trials. Safety in elderly patients and those with PS 2 was consistent with the overall population.

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