Author of

• 20152

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  P1.03 - Chemotherapy/Targeted Therapy (ID 689)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Chemotherapy/Targeted Therapy
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 22581

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    P1.03-026 - Interim Results of a Phase I Study of Nivolumab plus Nab-Paclitaxel/Carboplatin in Patients with NSCLC (ID 8478)

    09:30 - 09:30  |  Author(s): N. Trunova
    • Abstract

    Background:
    Chemotherapy, including taxanes, may augment the effects of immune checkpoint inhibitors through tumor cell lysis and subsequent antigen release. This phase I trial is evaluating safety and efficacy of nivolumab plus nab-paclitaxel in NSCLC (+ carboplatin), pancreatic cancer (± gemcitabine), and metastatic breast cancer. Interim results for Arm C, in which patients with NSCLC were treated with nivolumab starting in cycle 1, are presented.
    
    Method:
    Potential dose-limiting toxicities (DLTs) were evaluated in Part 1 before Part 2 expansion. Chemotherapy-naive patients with histologically/cytologically confirmed stage IIIB/IV NSCLC received 4 cycles of nab-paclitaxel 100 mg/m[2] days 1, 8, 15 plus carboplatin AUC 6 day 1 plus nivolumab 5 mg/kg day 15 of each 21-day cycle. In cycles ≥ 5, single-agent nivolumab was continued as maintenance therapy. Primary endpoints are number of patients with DLTs (Part 1) and percentage of patients with grade 3/4 treatment-emergent adverse events (TEAEs) or treatment discontinuation due to TEAEs (Parts 1/2). DLT-evaluable patients were those who received ≥ 2 complete nivolumab cycles and remained on study for 14 days after the last nivolumab dose in cycle 2, received ≥ 1 nivolumab dose and discontinued due to DLT before completing 2 nivolumab cycles, or experienced an equivocal DLT after ≥ 1 nivolumab dose. Secondary endpoints included PFS, DCR, ORR, DOR (all by RECIST v1.1), OS, and safety.
    
    Result:
    All patients (N = 22) received nab-paclitaxel/carboplatin; results for those who received nab-paclitaxel/carboplatin plus nivolumab (n = 20) are presented. The median age was 65.5 years (55% ≥ 65 years), 70% had ECOG PS 1, 75% were female, and 80% were white. More patients had adenocarcinoma (50%) than squamous cell carcinoma (35%; adenosquamous carcinoma, atypical, and data pending, 5% each). No DLTs were reported among 6 DLT-evaluable patients (Part 1). The most common grade 3/4 TEAEs were neutropenia (45%) and anemia (40%). No grade 3/4 colitis or pneumonitis was reported. Best ORR was 50% (1 CR [5%] and 9 PRs [45%]; 10 patients [50%] had SD); ORR was 43% (3 PRs among 7 patients) and 54% (1 CR and 6 PRs among 13 patients) in those with squamous and nonsquamous histologies, respectively. Median PFS was 10.5 months (95% CI, 4.9-18.1 months); 10.5 and 10.2 months for those with squamous and nonsquamous histologies, respectively.
    
    Conclusion:
    These results suggest that nab-paclitaxel/carboplatin plus nivolumab is tolerable for patients with NSCLC. Preliminary efficacy findings indicate promising antitumor activity across histologies. (NCT02309177)