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V.M. Villaflor



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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-030 - nab-Paclitaxel/Carboplatin Induction Therapy in Squamous (SCC) NSCLC: Interim Quality of Life (QoL) Results From ABOUND.sqm (ID 4343)

      14:30 - 14:30  |  Author(s): V.M. Villaflor

      • Abstract

      Background:
      Despite a high symptom burden in many patients with advanced NSCLC, limited data exist on QoL with first-line chemotherapy. Here we report results of an interim QoL analysis in patients with SCC NSCLC treated with nab-paclitaxel/carboplatin in the induction part of the ongoing ABOUND.sqm study.

      Methods:
      Chemotherapy-naive patients with advanced SCC NSCLC received 4 cycles of induction therapy with nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15 + carboplatin AUC 6 on day 1 (21-day cycles). Patients without progression after induction received (2:1) maintenance nab-paclitaxel 100 mg/m[2] on days 1 and 8 (21-day cycles) + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. The primary endpoint is progression-free survival (randomization to maintenance). Patient-reported QoL (exploratory endpoint) was assessed on day 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L).

      Results:
      207 patients were treated in the induction phase. Median age was 68 years; 66% of patients were male, and 99% had an ECOG PS 0-1. Out of 200 patients treated for ≥ 2 cycles, 180 (90%) completed baseline + ≥ 1 postbaseline QoL assessments. The mean change from baseline in LCSS symptom burden index and total score ranged from 6.6%-10.3% and 5.5%-9.5%, respectively. Clinically meaningful improvements (≥ 10 mm [visual analog scale]) from baseline were observed in composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis in 46% of patients. For individual EQ-5D-5L dimensions, ≥ 82% of patients maintained/improved from baseline and ≥ 33% reported complete resolution (Table).Figure 1



      Conclusion:
      In this interim analysis, 4 cycles of nab-paclitaxel/carboplatin treatment led to clinically meaningful improvements in LCSS pulmonary symptom items. Complete resolution of problems reported at baseline in EQ-5D-5L dimensions was observed in ≥ 33% of patients at least once during treatment. NCT02027428

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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-046 - Safety, Clinical Activity and Biomarker Results from a Phase Ib Study of Erlotinib plus Atezolizumab in Advanced NSCLC (ID 5215)

      14:30 - 14:30  |  Author(s): V.M. Villaflor

      • Abstract

      Background:
      Targeted therapy with erlotinib is effective in reducing tumor burden in EGFR-mutant non-small cell lung cancer (NSCLC). However, resistance to therapy develops almost universally. Atezolizumab, an engineered mAb that inhibits binding of PD-L1 to its receptors, PD-1 and B7.1, has demonstrated promising monotherapy activity in NSCLC. Given that atezolizumab may enhance and perpetuate anti-tumor immunity, we hypothesized that combining atezolizumab with erlotinib may improve both clinical response and durability in EGFR-mutant NSCLC.

      Methods:
      This Phase Ib study consisted of a safety-evaluation stage in patients with NSCLC regardless of EGFR status followed by an expansion stage in TKI-naïve patients with tumors harboring activating EGFR mutations. Patients were enrolled regardless of PD-L1 status. After a 7-day run-in with 150mg erlotinib PO QD alone, patients received 150mg erlotinib PO QD and 1200mg atezolizumab IV q3w. To evaluate immune biology, biopsies were obtained in expansion-stage patients pre-treatment, after erlotinib run-in, at weeks 4-6, and at progression. The primary objective was to evaluate the safety and tolerability of the combination. Secondary objectives included evaluation of the clinical activity per RECIST v1.1. Data cutoff, 11 April 2016.

      Results:
      Twenty-eight patients (safety stage, n = 8; expansion stage, n = 20) who received ≥ 1 dose of erlotinib or atezolizumab were considered safety evaluable. Median age was 61y (range, 47-84); median survival follow-up was 11.2mo (range, 0.8-24.2). The incidence of either treatment-related G3-4 AEs was 39% and for serious AEs, 50%. The most common atezolizumab-related G3-4 AEs were pyrexia and increased ALT. No pneumonitis was reported. No treatment-related G5 AEs occurred. Five patients discontinued atezolizumab due to treatment-emergent AEs. No DLTs were observed. In the expansion-stage population, ORR was 75% (95% CI, 51-91). Disease control rate (CR + PR + SD ≥ 24 weeks) was 90% (95% CI, 68-99), median PFS was 11.3mo (95% CI, 8.4-NE) and median DOR was 9.7mo (range, 4.2-11.7). Increases in intratumoral CD8+ T cells post-erlotinib run-in were observed in 8/13 evaluable paired biopsies. Higher intratumoral CD8+ T-cell prevalence and immune gene expression signatures at baseline were associated with improved PFS.

      Conclusion:
      The combination of full dose erlotinib plus atezolizumab demonstrated a manageable safety profile. While response rates and median PFS for combination treatment appear similar to those observed with erlotinib monotherapy, the addition of atezolizumab to erlotinib may lead to more durable clinical responses in some patients. Additional follow-up is required to evaluate the full potential of this combination treatment. NCT02013219