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J. Yun
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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
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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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 - 09:30 | Author(s): J. Yun
- Abstract
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.
