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O.J. Vidal



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    OA11 - Angiogenesis in Advanced Lung Cancer (ID 387)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA11.02 - Randomized Phase 1b/3 Study of Erlotinib plus Ramucirumab in First-Line EGFR Mut + Stage IV NSCLC: Phase 1b Safety Results (ID 3827)

      11:00 - 12:30  |  Author(s): O.J. Vidal

      • Abstract
      • Presentation
      • Slides

      Background:
      Ramucirumab, an antiangiogenic IgG1 VEGFR2-targeted monoclonal antibody, and erlotinib, an EGFR tyrosine kinase inhibitor, are both active in advanced NSCLC. This global phase 1b/3 study (NCT02411448) will assess safety, tolerability and efficacy of the combination of ramucirumab with erlotinib in previously untreated patients with EGFR mutation-positive stage IV NSCLC. Here we report phase 1b safety results.

      Methods:
      Eligible patients with ECOG PS 0-1, an activating EGFR mutation, and previously untreated stage IV NSCLC received ramucirumab 10 mg/kg intravenously on day 1 of repeating 14-day (± 3 days) cycle and erlotinib 150 mg orally daily. Treatment continued until disease progression or unacceptable toxicity. The primary objective of part A was to assess the safety and tolerability, in terms of dose limiting toxicities (DLT), of adding the recommended dose of ramucirumab for phase 3 (part B) to standard dose erlotinib. Data were analyzed separately for Japan (JP) (cohort 1) and US/EU (cohort 2). The DLT assessment occurred during the first 2 cycles (approximately 28 days).

      Results:
      As of Dec 16th, 2015, 14 patients were treated in the phase 1b part of this trial and 12 were DLT evaluable (6 JP; 6 US/EU). Overall, 6 grade (Gr) 3 treatment-emergent adverse events (TEAE) were noted, with at least one TEAE in 5 patients; no serious adverse events or Gr 4-5 TEAEs occurred. In the JP cohort the median age was 73 (64-79), 57% had ECOG PS 1 and 29% had a history of smoking. Four patients (57%) experienced a Gr 3 TEAE, of which one was a DLT (elevation of alanine aminotransferase) while the others (hypertension [n=2], dermatitis acneiform, and diarrhea) were not DLTs. In the US/EU cohort the median age was 71 (31-83), 86% had ECOG PS 1, and no patients had a history of smoking. One patient experienced Gr 3 TEAE of rash; no DLTs were observed in this cohort.

      Conclusion:
      Enrollment on the phase 1b portion of this trial is complete and the safety results were consistent with previous combinations of antiangiogenic/erlotinib in this patient population. No unexpected toxicities were identified. Phase 3 enrollment has been initiated maintaining the dose of ramucirumab at 10 mg/kg Q2W.

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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-072 - Interim Results from ABOUND.Sqm: Safety of nab-Paclitaxel/Carboplatin Induction Therapy in Squamous (SCC) NSCLC (ID 4391)

      14:30 - 15:45  |  Author(s): O.J. Vidal

      • Abstract

      Background:
      Improving tolerability of chemotherapy for patients with SCC NSCLC remains an important aspect of care. Induction therapy with nab-paclitaxel/carboplatin followed by nab-paclitaxel maintenance therapy could be an effective treatment option for this patient population. Interim safety results from the induction part of the ongoing ABOUND.sqm study are reported here.

      Methods:
      Patients with advanced SCC NSCLC who had no prior chemotherapy for metastatic disease received induction therapy with nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15 + carboplatin AUC 6 on day 1 (21-day cycles) for 4 cycles. Patients not progressing after 4 cycles were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m[2] on days 1 and 8 of each 21-day cycle + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. Progression-free survival from randomization into the maintenance part of the study is the primary endpoint. Secondary endpoints include safety (analyzed as treatment-emergent adverse events [TEAEs], overall survival, overall response rate, and disease control rate.

      Results:
      212 patients receiving induction treatment were evaluable in this analysis. Median age was 68 years; 66% of patients were male, 87% were white, and 99% had an Eastern Cooperative Oncology Group performance status of 0-1. Discontinuations were observed in 94/212 patients (44%) during induction. Of these, 35/94 (37%) discontinued due to disease progression, 23/94 (24%) due to AEs, 11/94 (12%) due to other reasons, 10/94 (11%) due to death, 9/94 (10%) due to patient decision, and 6/94 (6%) due to symptomatic deterioration. The median percentage of per-protocol dose of nab-paclitaxel was 75%, and median dose intensity was 74.87 mg/m[2]/week. At least 1 nab-paclitaxel dose reduction, missed dose, or dose delay occurred in 41%, 51%, and 58% of treated patients, respectively. Grade 3/4 TEAEs were mainly hematologic and included neutropenia (86/212; 41%), anemia (52/212; 25%), and thrombocytopenia (33/212; 16%). Grade 3/4 peripheral neuropathy occurred in 8/212 patients (4%).

      Conclusion:
      This interim report from the ABOUND.sqm study demonstrates that the tolerability profile of nab-paclitaxel/carboplatin was consistent with that reported in the phase III study, and no new safety signals were observed. Updated results will be presented at the meeting. NCT02027428