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O.J. Vidal



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    ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL01.03 - A Randomized Phase 2 Trial of Vintafolide and Docetaxel in Folate-Receptor Positive (FR+) Advanced NSCLC Patients: Final Efficacy Results (ID 1600)

      11:07 - 11:18  |  Author(s): O.J. Vidal

      • Abstract
      • Presentation
      • Slides

      Background:
      Vintafolide (folic acid-vinca alkaloid conjugate) binds to the folate receptor (FR), which is overexpressed in approximately 80% of patients with NSCLC, including patients with squamous cell and adenocarcinoma. Using the molecular imaging agent 99mTc-etarfolatide for SPECT imaging, the FR status of malignant lesions can be determined. Vintafolide has demonstrated single agent activity in patients with advanced NSCLC whose tumors all expressed FR [FR(100%)] compared to patients not FR(100%) (Edelman et al, 2012).

      Methods:
      This study randomized patients with advanced NSCLC whose tumors were FR(100%) to vintafolide, vintafolide + docetaxel, or docetaxel. Key eligibility criteria: age ≥18 years; 1 prior systemic therapy for advanced disease; ECOG PS 0-1. Patients underwent [99m]Tc-etarfolatide SPECT screening for FR assessment. Vintafolide (2.5 mg) was administered on days 1, 4, 8, 11 every 21 days and docetaxel (75 mg/m[2]) on day 1 every 21 days. The primary endpoint was progression-free survival (PFS). Pre-specified PFS comparisons were performed for vintafolide vs docetaxel and vintafolide+docetaxel vs docetaxel in all patients as well as those with adenocarcinoma. Significance testing for each PFS analysis was one-sided without adjustment for multiplicity (alpha=0.10). Overall survival (OS) was a secondary endpoint.

      Results:
      Over 14 months, 199 FR(100%) patients were randomized and treated (vintafolide: 63; vintafolide+docetaxel: 68; docetaxel: 68). Patient and disease characteristics were well-balanced between arms. The vintafolide+docetaxel arm met the primary endpoint of superior PFS over the docetaxel arm in all patients regardless of histology (17.0% censored; unstratified Cox model hazard ratio [HR] =0.75; unstratified one-sided p-value=0.0696) as well as in the prespecified 133 patient adenocarcinoma subgroup (18.8% censored; HR=0.73; p-value=0.0899). Trends in OS favored the vintafolide+docetaxel arm over the docetaxel arm in all patients (37.7% censored; HR=0.88; p-value=0.2874) and showed the greatest benefit in the adenocarcinoma subgroup (42.8% censored; HR=0.70; p-value=0.1018). The single-agent vintafolide arm was not superior to docetaxel. Vintafolide+docetaxel treatment was associated with more neutropenia (all grades: 77% versus 62%), febrile neutropenia (13% versus 6%), and peripheral neuropathy (34% versus 21%) compared to docetaxel alone.

      Conclusion:
      The addition of vintafolide to docetaxel resulted in a statistically significant improvement in PFS in FR(100%) NSCLC patients regardless of histology (PFS HR= 0.75) and in the adenocarcinoma subset (PFS HR= 0.73). Additionally, there was a trend towards improvement in OS in all patients regardless of histology (OS HR= 0.88) and in the adenocarcinoma subset (OS HR= 0.70). Vintafolide +docetaxel was generally well tolerated, although rates of neutropenia, neutropenic fever, and neuropathy were higher than with docetaxel alone. Final survival results will be presented at the conference.

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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-091 - Multicenter, Randomized, Double-Blind Study of Erlotinib plus Ramucirumab or Placebo in Patients with EGFR Mutation-Positive Metastatic NSCLC (ID 1560)

      09:30 - 09:30  |  Author(s): O.J. Vidal

      • Abstract
      • Slides

      Background:
      Ramucirumab, a human IgG1 monoclonal antibody, binds to Vascular Endothelial Growth Factor (VEGF) Receptor 2, preventing binding of VEGF-A, C and D. Ramucirumab in combination with docetaxel has demonstrated improvement in overall survival, progression free survival (PFS), objective response rate and disease control rate in 2nd line treatment of NSCLC patients in the phase III REVEL study, which included non-squamous and squamous cell carcinoma patients. Although erlotinib is recognized as one of the standard of care options in the frontline treatment of patients whose tumors harbor an Epidermal Growth Factor Receptor (EGFR) mutation, it is hypothesized that the duration of disease control would be greater when an antiangiogenic agent such as ramucirumab is added to erlotinib. This global phase Ib/III trial will assess safety, tolerability and efficacy (phase III) of the combination of ramucirumab with erlotinib in previously untreated stage IV NSCLC patients harboring activating EGFR mutations. The trial is planned to be conducted in ~120 sites in the Americas, Europe, and Asia and is currently open for enrollment. (RELAY, NCT02411448)

      Methods:
      In part A (phase Ib) approximately 12 patients (6 Japan + 6 US/EU) will receive ramucirumab (10mg/kg on day 1) every two weeks + erlotinib (150 mg/day). DLT assessment will be performed after patients complete four weeks of treatment. In part B (phase III), approximately 450 patients will be randomized in a 1:1 ratio to receive ramucirumab or placebo every two weeks with erlotinib until disease progression, unacceptable toxicity, or other withdrawal criteria are met. The primary endpoint is PFS. There are 3 planned interim analyses that will evaluate safety, futility and efficacy, respectively. Other secondary endpoints include overall survival, objective response rate, disease control rate, duration of response, safety and quality of life.

      Results:
      Not applicable

      Conclusion:
      Not applicable

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