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C.J. Langer



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    MINI 07 - ChemoRT and Translational Science (ID 110)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      MINI07.15 - Discussant for MINI07.11, MINI07.12, MINI07.13, MINI07.14 (ID 3325)

      C.J. Langer

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MTE 02 - Patients, Investigators and Pharmaceuticals Working Together to Accelerate Research and Access: The Lung Cancer Master Protocol (Lung-MAP) Clinical Trial (Ticketed Session) (ID 54)

    • Event: WCLC 2015
    • Type: Meet the Expert (Ticketed Session)
    • Track: Advocacy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/07/2015, 07:00 AM - 08:00 AM, 105
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      MTE02.01 - Patients, Investigators and Pharmaceuticals Working Together to Accelerate Research and Access: The Lung Cancer Master Protocol (Lung-MAP) Clinical Trial (ID 1979)

      C.J. Langer

      • Abstract
      • Presentation
      • Slides

      Abstract:
      The traditional obstacles to approval of oncologic therapeutic agents, especially targeted therapies that address a rare-biomarker defined group of patients are the long processes from initial drug discovery to clinical implementation, the difficulties in recruitment for these clinical trials and high number of screen failures and the overall low rate of enrollment in clinical trials. The Lung Master Protocol (Lung-MAP, S1400) is a precedent-setting clinical trial designed to advance the efficient development of targeted therapies for squamous cell cancer of the lung (SCCA). There are few new effective therapeutic options for patients with advanced lung SCCA. Immunotherapies, including nivolumab, have already shown clear benefit for patients with SCCA in 2015 leading to approval by the FDA which has been an unprecedented step forward for the treatment of patients, however we are still lacking predictive markers for these therapies that are reliably selecting patients more likely to benefit. Lung-MAP (S1400) is aiming to identify biomarker-drug pairs that will lead to successful therapeutic outcomes and registration of new agents. It is a registration-intent master protocol that includes a screening component and clinical trial component; the clinical trial component includes multiple sub-studies which independently evaluate investigational therapies. The clinical trial component is designed to be modular such that new sub-studies can be added either as other sub-studies close or as new biomarker-drug pairs are identified for testing in this patient population. Lung-MAP is utlilizing a broad NGS screening platform capitalizing on the expanding application of genomic sequencing in oncology that has through the Cancer Genome Atlas and other sequencing initiatives revealed targetable genetic aberrations including gene mutations, rearrangements, amplifications, and deletions, and creating an immense opportunity to implement personalized therapy with a high potential to improve patients outcomes. Immunotherapy has been integrated in the design of Lung-MAP from its launch in June of 2014. The original study design and structure is shown in the figure. Figure 1 The modular design of the study has allowed for the flexibility to adapt to the approval of nivolumab and the hault in further development of AMG102 (rilotumumab) with discontinuation of the corresponding sub-study by implementing timely modifications which include the following:1)Eligibility has changed from exclusively second line therapy to second-or more line therapy 2)Pre-screening, while patient receive first line therapy has been added to boost accrual 3)the unmatched arm has been changed to a single (not randomized) arm study with the anti-PD-L1 agent MEDI-4736. Theses changes are reflected in the figure. Each independently conducted and analyzed sub-study specifies investigator-assessed progression-free survival (IA-PFS) and overall survival (OS) as the co-primary endpoints for the phase 3 primary objectives. The primary objectives for the phase 3 are to determine if there is a statistically significant difference in OS and to determine if there is both a clinically meaningful and statistically significant difference in IA-PFS. The conduct of Lung-MAP relies on close collaboration (a public-private partnership) among the NCI and NCTN (spearheaded by SWOG), the pharmaceutical industry, the Foundation for the NIH (FNIH), Friends of Cancer Research, advocates, and FDA. This Master Protocol will improve genomic screening of SCC patients for clinical trial entry, and improve time lines for drug-biomarker testing, allowing for inclusion of the maximum numbers of otherwise eligible patients. The clinical trial continues to be updated following science and alterations in the therapeutic landscape, with adaptations in design and incorporation of new agents against matched targets and the implementation of novel immunotherapy approaches for the unmatched arm. Figure 2





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    MTE 23 - Standard Therapy for Advanced NSCLC in Absence of Driver Mutations (Ticketed Session) (ID 75)

    • Event: WCLC 2015
    • Type: Meet the Expert (Ticketed Session)
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2015, 07:00 AM - 08:00 AM, 103
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      MTE23.01 - Standard Therapy for Advanced NSCLC in Absence of Driver Mutations (ID 2010)

      C.J. Langer

      • Abstract
      • Presentation

      Abstract not provided

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    ORAL 33 - ALK (ID 145)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL33.06 - Brigatinib (AP26113) Efficacy and Safety in ALK+ NSCLC: Phase 1/2 Trial Results (ID 2125)

      C.J. Langer

      • Abstract
      • Presentation
      • Slides

      Background:
      Brigatinib (AP26113), an investigational oral tyrosine kinase inhibitor with FDA breakthrough therapy designation for the treatment of patients with crizotinib-resistant advanced ALK+ NSCLC, has preclinical activity against both rearranged ALK and clinically identified crizotinib-resistant mutant ALK.

      Methods:
      This is an ongoing phase 1/2, single-arm, open-label, multicenter study in patients with advanced malignancies (N=137; NCT01449461). Patients received escalating total daily doses of brigatinib from 30–300 mg during phase 1. Daily regimens of 90 mg, 180 mg, or 90 mg for 7 days followed by 180 mg were evaluated in phase 2. Safety is reported for all treated patients; antitumor efficacy (ORR and PFS per RECIST v1.1) is reported for ALK+ NSCLC patients.

      Results:
      Seventy-nine (58%) patients had ALK+ NSCLC. Median age was 54 (29–83) years, 49% were female, 90% had prior crizotinib, and 47% had ≥2 prior chemotherapy regimens. As of February 17, 2015, 45/79 (57%) ALK+ NSCLC patients remained on study, with median time on treatment of 12.6 months (1 day to 35.5 months; n=79); ORR/PFS for evaluable ALK+ NSCLC patients was 74%/13.4 months (additional data shown in Table). In a post hoc independent radiological review of patients with brain metastases at baseline (as of January 19, 2015), 8/15 (53%) patients with measurable brain lesions ≥10 mm had an intracranial response (≥30% decrease in sum of longest diameters of target lesions) and 9/30 (30%) patients with only nonmeasurable lesions had disappearance of all lesions. Treatment-emergent AEs in ≥30% of total patients, generally grade 1/2, included nausea (52%), fatigue (42%), diarrhea (40%), headache (33%), and cough (32%). Early-onset pulmonary events, which occurred ≤7 days after treatment initiation and included dyspnea, hypoxia, and new pulmonary opacities on chest CT consistent with pneumonia or pneumonitis, were reported in 13/137 (9%) patients overall (6/44 [14%] at 180 mg qd; 2/50 [4%] at 90 mg qd [maintained or escalated to 180 mg qd after 7 days]).

      Response and PFS With Brigatinib
      All Evaluable ALK+ NSCLC Patients n=78 Prior Crizotinib n=70 No Prior Crizotinib n=8
      Response, n(%)
      OR (CR+PR) 58(74) 50(71) 8(100)
      [95% CI] [63–84] [59–82] [63–100]
      CR 7(9) 4(6) 3(38)
      PR 51(65) 46(66) 5(63)
      SD 11(14)[a] 11(16)[a] 0
      PD 6(8) 6(9) 0
      Termination before scan 3(4) 3(4) 0
      Median duration of response,[b] mo 11.2[c] 9.9[d] Not reached[e]
      Median PFS,[b] mo 13.4 13.4 Not reached
      [a]Includes non-CR/non-PD for 4 patients with no measurable disease at baseline [b]Kaplan-Meier estimate [c]n=55 evaluable [d]n=48 evaluable [e]n=7 evaluable


      Conclusion:
      Brigatinib has promising antitumor activity in ALK+ NSCLC patients with (71% ORR; PFS 13.4 months) or without (100% ORR) prior crizotinib, including patients with brain metastases (53% ORR in patients with measurable brain lesions). Early-onset pulmonary events were less frequent when starting at 90 vs 180 mg qd. A pivotal global phase 2 trial (ALTA) of brigatinib 90 mg qd vs 90 mg qd for 7 days followed by 180 mg qd in crizotinib-resistant ALK+ NSCLC is ongoing.

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    P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P1.01-059 - Steps to Improve NSCLC Patient Outcomes Utilizing Mobile Apps - Survey Findings (ID 792)

      C.J. Langer

      • Abstract

      Background:
      Integration of mobile devices/health-related apps into medical practice is transforming healthcare. For clinicians treating NSCLC, the addition of a new app, NSCLC @Point of Care, and its patient companion app, are practice-based tools designed to provide content at the time it is actually needed and the ability to sync with patient data, potentially enabling better decisions, outcomes and care. This survey assesses how this mobile dashboard is used in the NSCLC setting, its effect as a learning tool, and how it can improve patient outcomes.

      Methods:
      To assess how clinicians utilize the NSCLC @Point of Care dashboard and patient companion app, Projects In Knowledge, the CME provider, sent an online survey to its proprietary database of over 53,000 clinicians caring for NSCLC patients. Respondents reported: demographic information, use of EMR technology, frequency and reasons for accessing the NSCLC @Point of Care app, interest in tracking patient-reported data, and use of patient-reported data in institutional EMR reports.

      Results:
      Overall findings show a large number of responding clinicians use EMR technology, access the NSCLC @Point of Care App daily for relevant disease/treatment-specific information, and want to track patient-reported data. The survey demonstrates many clinicians are in agreement that the clinician app, NSCLC @Point of Care, and its companion app will not only provide important disease- and treatment-specific information that they need and can access at point of care, but also improve communication of critical and accurate patient data in real-time to ensure optimal interventions and patient outcomes, incorporate patient-reported data from the companion app into EMRs and believe this maneuver can streamline time efficiencies in practice.

      Conclusion:
      Management of NSCLC, a leading cause of cancer-related mortality, is evolving so rapidly that it is difficult for clinicians to keep current and integrate new improved treatment strategies into practice. Many clinicians surveyed believe the NSCLC @Point of Care dashboard provides a desirable approach for busy clinicians to access information needed to support practice change and improve patient outcomes through point of care accessibility.

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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: 2
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      P2.01-065 - <em>nab</em>-Paclitaxel + Carboplatin in Advanced NSCLC: Analysis of Age and Renal Function (ID 1559)

      C.J. Langer

      • Abstract
      • Slides

      Background:
      Renal impairment increases with age and can impact treatment decisions. In a phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly improved the overall response rate (ORR; primary endpoint) compared with solvent-based paclitaxel plus C (sb-P/C) in patients with advanced NSCLC (Socinski et al. J Clin Oncol. 2012;30:2055-2062). In a subgroup analysis of this phase III trial, nab-P/C demonstrated promising efficacy and was well tolerated in patients with or without renal impairment (Langer et al. Clin Lung Cancer. 2015;16:112-120). This analysis examined outcomes of patients in the phase III trial stratified by age and renal function.

      Methods:
      Patients with histologically or cytologically confirmed stage IIIB/IV NSCLC and no prior chemotherapy for metastatic disease received either nab-P 100 mg/m[2] on days 1, 8, and 15 or sb-P 200 mg/m[2] on day 1 in combination with C AUC 6 on day 1 every 21 days (randomized 1:1). Treatment continued until disease progression. Baseline renal function (creatinine clearance [CrCl]) was assessed in a central lab. ORR and progression-free survival (PFS) were assessed by blinded, centralized review. P values for ORR were based on the chi-square test, and those for overall survival (OS) and PFS were based on the log-rank test.

      Results:
      Treatment with nab-P/C resulted in improved outcomes compared with sb-P/C in patients with mild renal impairment, regardless of age (Table). nab-P/C also consistently demonstrated greater treatment effect compared with sb-P/C for ORR and similar or better PFS and OS in patients ≥ 60 years, regardless of renal function. In patients with either mild renal impairment or normal renal function, the toxicity profiles in each treatment arm were similar to those of the intent-to-treat population.

      Conclusion:
      These results suggest that, in general, clinical outcomes in patients with advanced NSCLC and mild renal impairment are better with nab-P/C vs sb-P/C, regardless of age. It should be noted that these were small subset analyses and results should be interpreted with caution. Figure 1



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      P2.01-088 - <em>nab</em>-Paclitaxel + Carboplatin for Elderly Patients with Advanced NSCLC (ABOUND.70+) (ID 1084)

      C.J. Langer

      • Abstract
      • Slides

      Background:
      Treatment of elderly patients with non-small cell lung cancer (NSCLC) is challenging due to comorbidities and reduced tolerability; as a result, these patients often receive suboptimal treatment. In addition, 5-year survival rates are lower in elderly than in younger patients with NSCLC. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly increased median overall survival (OS) vs solvent-based paclitaxel plus C in a subset of patients ≥ 70 years of age with advanced NSCLC (19.9 vs 10.4 months; HR 0.583; P = 0.009; Socinski et al. Ann Oncol. 2013;24:314-321). However, 55% of elderly patients treated with nab-P/C required dose reductions and 84% had dose delays, primarily due to adverse events, including myelosuppression. In the open-label, multicenter phase IV ABOUND.70+ trial, the safety and efficacy of 2 different schedules of first-line nab-P/C treatment will be evaluated prospectively in elderly patients with advanced NSCLC.

      Methods:
      Approximately 284 patients with NSCLC ≥ 70 years of age who are not candidates for curative surgery or radiation therapy will be randomized 1:1 to nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus C AUC 6 on day 1 every 21 days or the same nab-P/C dose every 21 days followed by a 1-week break. Key eligibility criteria include histologically/cytologically confirmed locally advanced or metastatic NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and absence of preexisting peripheral neuropathy (PN) grade > 2. Patients will be stratified by ECOG performance status (0 vs 1) and histology (squamous vs nonsquamous). ClinicalTrials.gov identifier NCT02151149.

      Key Endpoints
      Primary Percentage of patients developing either PN grade ≥ 2 or myelosuppression grade ≥ 3
      Secondary Safety Progression-free survival OS Overall response rate
      Exploratory[a] Healthcare resource utilization throughout the study Changes in quality of life
      [a] Additional exploratory endpoints may be defined in the statistical analysis plan if applicable.

      Results:
      TPS Abstract Section NA

      Conclusion:
      TPS Abstract Section NA

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-054 - Etirinotecan Pegol (NKTR-102) in the Treatment of Patients with Metastatic NSCLC after Failure of 2nd Line Treatment: A Phase II Study (ID 717)

      C.J. Langer

      • Abstract
      • Slides

      Background:
      3rd line treatment options are limited for patient (pts) with metastatic NSCLC. NKTR-102 is a long-acting topoisomerase-I inhibitor designed to concentrate in tumors and provide continuous exposure throughout the chemotherapy cycle. Based on clinical activity of irinotecan in NSCLC, we conducted a Phase II single arm trial to evaluate efficacy of NKTR-102.

      Methods:
      Pts >18 yrs with histologically proven NSCLC who received 2 prior systemic therapy regimens were eligible. Measurable disease, ECOG PS ≤1 and adequate end organ function were required. NKTR-102, 145mg/m2 was administered IV q3 weeks till progression. Response was assessed q6 weeks by RECIST 1.1. Primary endpoint was overall response rate. Secondary endpoints were progression free survival (PFS), overall survival (OS) and safety. Simon two-stage design was implemented; if 0/12 responses were observed in the 1st stage, the study would be terminated for futility. If there was at least 1 objective response in the 1st stage, the study would continue to stage 2, enrolling an additional 25 pts, for a total of 37.

      Results:
      Between 01/2013 and 01/2015, 37 pts have been enrolled. Median age 63 yrs (18-82), 45% female, ECOG PS 0=8 pts, 92% current/former smokers, 9 pts with squamous cell, 28 had adenocarcinoma. Median time from diagnosis to initiation of NKTR-102 was 18 mos (6-72). Pts received a median of 3 cycles (1-13). All pts were evaluable for response rate and toxicity. One pt in Stage I (adenocarcinoma) had a partial response. Fifteen pts had stable disease, 7 pts are still on treatment. 3 pts had Grade 3 GI toxicity attributable to NKTR-102. 6 pts required a dose reduction to 120 mg/m2 due to diarrhea. There was no hematological toxicity. Median PFS was 2.3 mos. For pts with >1 yr follow up (n=20), median OS was 5.5 mos. Complete PFS and OS data will be presented.

      Conclusion:
      NKTR-102 is well tolerated and leads to stabilization of disease in third line treatment of metastatic NSCLC. These clinical data combined with a favorable safety profile warrant further clinical investigation of this agent. Clinical trial information: NCT01773109.

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    P3.11 - Poster Session/ Palliative and Supportive Care (ID 231)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      P3.11-012 - Improving Clinical Trial Awareness in NSCLC: Pilot Testing a Novel Healthcare IT Platform for Incorporating Education at the Point of Care (ID 3253)

      C.J. Langer

      • Abstract

      Background:
      Cancer clinical trial (CCT) participation is critical to improving the care of patients with Non-Small Cell Lung Cancer (NSCLC), yet low participation in CCTs persists. Little is known about the specific barriers to CCT participation among patients with NSCLC. The On Q Care Planning System (CPS) is an electronic tablet based platform adapted to address potential barriers to CCT participation through algorithm-driven identification of and education about patient specific CCTs at the point of care. The primary objectives of this study were to 1) characterize knowledge, attitudes and beliefs about CCTs among patients with NSCLC and their providers and 2) evaluate the impact of the CPS on CCT participation.

      Methods:
      We performed a multi-site pilot implementation project of CPS as a clinical decision support and patient education tool. Patients were eligible if they had recurrent/metastatic NSCLC. The CPS contained clinical trial eligibility criteria for many CCTs in NSCLC open at the primary research site, as well as selected CCTs from surrounding cancer centers. Study aims were evaluated using patient and provider self-report surveys. Knowledge, attitudes and beliefs about CCTs for both patient’s and provider’s was captured through self-assessment surveys, using a combination of true/false questions and 1-5 Likert scale measures where 5 indicated highest level of agreement. Effect of CPS on CCT enrollment was measured by rate of enrollment in CCTs following the intervention, compared to historical rates of NSCLC CCT participation at our institution.

      Results:
      From April 2015 through July 2015, 9 providers (medical oncologists and nurse practitioners) and 79 patients with recurrent/metastatic NSCLC have been enrolled from 2 participating cancer centers. While providers reported being aware of open CCTs (mean score (m)=4.6), they felt that lack of adequate information about CCTs (m=3.0) and having time to review eligibility (m=2.6) were key barriers to CCT enrollment. Patients agreed that there were both the personal (m=3.7) and societal (m=4.1) benefits of CCTs. Similar to providers, key barriers to CCT participation for patients centered around lack of knowledge (concern about not knowing what drug they would receive (m=3.5) and that CCT agents would be too toxic (m=3.2)). Of the patients enrolled, 22 were at a point of new treatment or change in treatment and thus evaluable for rate of CCT referral and enrollment. In this subgroup, 21 (95.5%) received care plans with CCT recommendations. Following the study intervention visit, 8 (36.4%) of evaluable patients enrolled in a clinical trial. This compares favorably both with historical rates at our institution, where 13.8% of treatment eligible patients with lung cancer have been enrolled in CCTs, and with national averages which are less than 5%.

      Conclusion:
      CCT enrollment is critical to advancing the treatment of NSCLC, yet CCT enrollment in NSCLC remains low. For both providers and patients, the lack of readily accessible information about clinical trial eligibility and protocol details is a major barrier to CCT enrollment. The CPS is specifically designed to address these barriers. Indeed, in this pilot study, we showed a promising rate of CCT accrual with the use of the CPS. These findings should be validated in larger, randomized studies.