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Pia Baumann



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      139P - Real-world immuno-oncology (IO) therapy treatment patterns and outcomes in patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) in the United States (ID 382)

      12:30 - 13:00  |  Author(s): Pia Baumann

      • Abstract
      • Slides

      Background

      Cancer immunotherapies are new treatment options in advanced NSCLC. Evidence of IO therapy efficacy in tumors with activating mutations, such as ALK rearrangements, is lacking. This retrospective study describes the characteristics of ALK+ NSCLC patients treated with IO therapy and assesses treatment outcomes (time to treatment discontinuation, real-world progression-free survival [rwPFS], overall survival [OS]).

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The Flatiron Health Electronic Health Record (EHR)−derived database (Jan 2011−Sep 2017) was used to identify patients with advanced ALK+ NSCLC who had received ≥1 ALK TKI and IO therapies (nivolumab, pembrolizumab, atezolizumab). Discontinuation of IO therapy was defined as switch to an ALK TKI or chemotherapy, death, or gap between last IO therapy administration and last follow-up date of > 120 days. rwPFS was estimated as the time from treatment initiation to progression (abstracted from clinician notes and radiology reports) or death. Time to discontinuation, rwPFS, and OS were analyzed using Kaplan-Meier methods.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Of 335 ALK+ NSCLC patients with follow-up between Jan 2015−Sep 2017, 32 (9.5%) patients were treated with IO therapy. Median age was 62.5 years, with 78.1% of patients diagnosed at stage IV, and 24 patients receiving nivolumab. Of the 32 IO treated patients, 15.6% received IO therapy before first ALK TKI, and 59.4% were treated with IO therapy after ≥2 ALK TKIs. Median (95% CI) time to discontinuation of IO therapy was 1.88 months (0.95 − 2.80), rwPFS was 2.17 months (1.18 − 2.93), and OS was 6.71 months (2.80−NE).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      We identified ALK+NSCLC patients who received IO therapy; most of whom were treated post ALK TKI. Time to discontinuation of IO therapy was short, and real-world effectiveness (rwPFS and OS) was limited. These results point to IO therapy’s relative futility in ALK+ NSCLC patients. Compared to IO therapy, several approved ALK inhibitors have shown better effectiveness in both first and later lines of therapy. However, the optimal sequencing of ALK inhibitors with other therapies, including chemotherapy and IO therapy, remains unclear.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Jane Kondejewski, PhD of SNELL Medical Communication, Inc.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      213f68309caaa4ccc14d5f99789640ad Funding

      Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      682889d0a1d3b50267a69346a750433d Disclosure

      M.M. Lin: Employer: Millennium Pharmaceuticals, Inc. a wholly owned subsidiary of Takeda Pharmaceutical Company limited, which funded this study. X. Pan, Y. Yin, P. Hou, P. Baumann: Employee of Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited which funded this study. M. Jahanzeb: Research Grant: Lilly, Boehringer Ingelheim, Callisto; Research Grant, consultant: Millennium/Takeda, Novartis, Ipsen, Roche/ Genentech, Pfizer.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Proffered Paper session II (ID 61)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 09:00 - 10:30, Room A
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      108O - Treatment duration of brigatinib in patients enrolled in the international expanded access program (EAP) (ID 448)

      09:00 - 10:30  |  Author(s): Pia Baumann

      • Abstract
      • Presentation
      • Slides

      Background

      Brigatinib is a next-generation anaplastic lymphoma kinase (ALK) inhibitor for the treatment of advanced ALK+ non-small cell lung cancer (NSCLC). In June 2016, the international EAP was opened to enable access to brigatinib prior to commercial launch for patients with unmet medical need, including those who had exhausted available therapies or were unable to participate in a clinical study. This retrospective analysis evaluated real-world treatment duration using brigatinib EAP shipment and discontinuation data.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      This analysis included data from patients with locally advanced or metastatic ALK+ NSCLC who were resistant or intolerant to at least one ALK inhibitor and had received brigatinib across multiple lines of therapy through the EAP between July 2016 and Nov 7, 2018; most patients were European. Treatment duration was recorded for patients with confirmed discontinuation, as stated on their discontinuation forms. Discontinuation was assumed for patients without confirmed discontinuation if there was a gap of > 120 days between data cutoff and last medication shipment date. Time to treatment discontinuation was estimated from Kaplan-Meier curves. Subgroup analyses were conducted based on whether patients had received prior alectinib, ceritinib, or lorlatinib.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      A total of 604 patients (42.4% male; median age, 58.0 years) received brigatinib, with the majority receiving brigatinib as a 3+ line agent. Across all lines of therapy, median time to brigatinib discontinuation was 10.95 months (95% CI 8.65 − 13.88). Median time to discontinuation (95% CI) was 8.72 months (7.50 − 14.93) after alectinib (N = 111), 10.33 months (8.13 − 13.62) after ceritinib (N = 249) and 7.5 months (4.47−NE) after lorlatinib (N = 37). Few patients reported discontinuation due to adverse events (N = 4, 0.7%).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In the real world, despite a heterogeneous patient population treated with multiple prior ALK inhibitors, time to discontinuation of brigatinib (from all lines) was almost one year. Although complete disease progression status of the patients was absent, this time-to-discontinuation analysis indicates encouraging benefit with a manageable safety profile for brigatinib.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Jane Kondejewski, PhD, SNELL Medical Communicaiton, Inc.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      213f68309caaa4ccc14d5f99789640ad Funding

      Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      682889d0a1d3b50267a69346a750433d Disclosure

      M.M. Lin, X. Pan, P. Hou, S. Allen, P. Baumann: Employee: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited which funded this study. M.J. Hochmair: Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Merck Sharp & Dohme, Pfizer, Roche; Consulting, advisory roles: Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Roche.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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