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Ramaswamy Govindan

Moderator of

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    WS01 - Cancer Genomics Workshop (Ticketed Session) (ID 100)

    • Event: WCLC 2019
    • Type: Workshop
    • Track:
    • Presentations: 2
    • Now Available
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      WS01.02 - Exercise 1: Cancer Gene Panels: Methods and Application (Now Available) (ID 3824)

      08:00 - 11:15  |  Presenting Author(s): Richard L. Haspel

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      WS01.04 - Exercise 2: Cancer Gene Panels: Result Interpretation and Clinical Utility (Now Available) (ID 3826)

      08:00 - 11:15  |  Presenting Author(s): Richard L. Haspel

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.04 - Discussant - MA13.01, MA13.02, MA13.03 (Now Available) (ID 3776)

      14:00 - 15:30  |  Presenting Author(s): Ramaswamy Govindan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
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      OA02.02 - Phase 1 Study of Safety, Tolerability, P­­K and Efficacy of AMG 510, a Novel KRAS G12C Inhibitor, Evaluated in NSCLC (ID 1020)

      10:30 - 12:00  |  Presenting Author(s): Ramaswamy Govindan

      • Abstract
      • Slides

      Background

      The KRASG12C mutation is found in approximately 14% of lung adenocarcinoma and 11% of NSCLC pts. Currently, no approved therapy targets this mutation. AMG 510 is a novel small molecule that specifically and irreversibly inhibits KRASG12C by locking it in an inactive GDP-bound state.

      Method

      A phase 1, first-in-human, open-label, multicenter study (NCT03600883) is evaluating the safety, tolerability, PK, and efficacy of AMG 510 in adult pts with locally-advanced or metastatic KRASG12C mutant solid tumors, including NSCLC pts. Safety is the primary endpoint; ORR (assessed every 6 wks), DOR, PFS, and PK are key secondary endpoints. Important inclusion criteria: KRASG12C mutation identified through DNA sequencing; measurable or evaluable disease; progression on standard therapy; ECOG PS ≤2; life expectancy >3 mo. Important exclusion criteria: active brain metastases; myocardial infarction within 6 mo. The maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) will be identified during the dose exploration. Once identified, additional pts with advanced solid tumors carrying the KRASG12C mutation will be enrolled during dose expansion. AMG 510 is given PO until disease progression, intolerance, or consent withdrawal.

      Result

      As of 4 April 2019, thirteen [5 men and 8 women; median age 63 yrs (range: 53–77)] of 35 pts enrolled in 4 dose exploration cohorts have NSCLC. These pts had a median of 3 (range: 1–5) prior lines of treatment (tx). On-study tx duration had a median of 59 days (range:9–192 d). No DLTs have been reported. Six NSCLC pts reported 10 treatment-related AEs (6 grade 1; 2 grade 2; 2 grade 3). The grade 3 related AEs were anemia in a pt with baseline grade 2 anemia and diarrhea lasting 2 d in a second pt. The most frequently reported AEs were decreased appetite (n=4 subjects) and diarrhea (n=3 subjects). Best tumor response has been evaluated in 10 NSCLC pts; 3 pts have not reached their first assessment. Of these 10 evaluable pts, 5 pts had a PR (2 of which are confirmed PRs), 4 had SD and 1 had PD. Of 13 NSCLC pts, 11 pts remain on-study and continue their AMG 510 and 2 pts have discontinued treatment due to PD during study wks 6 and 26.

      Conclusion

      AMG 510 has been well tolerated at all 4 dose levels explored and has shown antitumor activity when administered as monotherapy to pts with advanced KRASG12C mutant NSCLC. Enrollment is on-going.

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    OA13 - Ideal Approach to Lung Resection and Novel Perioperative Therapy (ID 146)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Now Available
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      OA13.01 - SPECS2 Lung Cancer Consortium Prospective Multicenter Validation of Prognostic Signature for Early Stage Squamous Lung Cancer (Now Available) (ID 2723)

      11:30 - 13:00  |  Author(s): Ramaswamy Govindan

      • Abstract
      • Presentation
      • Slides

      Background

      Squamous Lung Cancer (SC) which constitutes 30% of all non-small cell lung cancers (NSCLC) has few targeted therapy options for advanced disease. Surgery for early SC is the best treatment strategy; however, even patients who undergo surgery for stage IA or IB disease are still at a substantial risk for recurrence and death. Adjuvant therapy is not currently indicated for stage I SC smaller than 4 cm. Prior reports suggest gene expression-based signatures that may predict recurrence in patients with stage I SC, but none has been validated or is in clinical use. The SPECS2 Lung Cancer Consortium was assembled to compare and attempt to validate previously published prognostic signature(s) according to the guidelines proposed by Subramanian and Simon (J Natl Cancer Inst 2010; 7:327).

      Method

      The multi-institutional team assembled 249 frozen SC samples representing six participating institutions (cohort 1). These samples were fully annotated in a redcap database hosted by the independent statistical core. Cohort 2 was assembled utilizing 234 frozen SC samples from a prospective multi-institutional NCTN lung biobanking protocol (NCT00899782). RNA was extracted and profiled with U133A microarrays (Affymetrix) in independent core facilities. The data was transferred directly to the SPECS2 Lung statistical core in collaboration with the Alliance Statistical core and the performance of 6 most promising candidate signatures was evaluated relative to a base model that included only age, gender and AJCC stage (editions 6, 7, 8).

      Result

      Analysis of Cohort 1 demonstrated that only one signature (Raponi et al, Cancer Res 2006; 66:7466) significantly enhanced prognosis relative to the base model, independent of AJCC edition. This was also observed in Cohort 2, where Uno’s C index associated with AJCC 8th edition stage, sex and age (0.561; 0.468-0.654) was significantly (p <0.05) increased when the prognostic signature was added to the model (0.683; 0.611-0.755).

      Conclusion

      The SPECS2 Lung Cancer Consortium was successful in validating a previously published prognostic molecular signature for early stage SC using rigorous experimental design. To our knowledge, this is the first unbiased validation of a lung cancer prognostic signature using multi-institutional prospective specimens. These results support a clinical trial designed to evaluate the potential role of adjuvant therapy in completely resected early stage SC.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-73 - An Explorative Analysis of Pemetrexed +/- Pembrolizumab Maintenance from KEYNOTE-189 Versus PARAMOUNT, PRONOUNCE, and JVBL (ID 756)

      09:45 - 18:00  |  Author(s): Ramaswamy Govindan

      • Abstract
      • Slides

      Background

      Recently, the phase 3 KEYNOTE-189 study demonstrated improved progression-free survival (PFS) and overall survival (OS) when pemetrexed/platinum doublet was combined with pembrolizumab as first-line treatment in patients with non-squamous NSCLC. The specific benefits of maintaining pemetrexed in combination with pembrolizumab after the triplet with platinum has not been previously assessed.

      Method

      Using patient level data, we selected patients who had ≥5 cycles of pemetrexed (including the induction phase with platinum) from 3 randomized non-pembrolizumab clinical trials (PARAMOUNT, PRONOUNCE, and JVBL; N=486). As such, patients in the KEYNOTE-189 trial who had ≥5 cycles of pemetrexed in both arms (placebo arm; N=135, versus pembrolizumab arm; N=310) were analyzed. PFS and OS were evaluated by Kaplan-Meier estimator and Cox proportional hazard model; treatment emergent adverse events (TEAEs) were compared by descriptive statistics.

      Result

      Baseline characteristics of the selected population with ≥5 cycles of pemetrexed were comparable between the pooled trials and KEYNOTE-189. Median PFS for patients with ≥5 cycles of pemetrexed was 5.6 months (95% CI: 4.6-5.8) from the pooled non-pembrolizumab trials and 6.6 months (95% CI: 5.4-7.1) in the placebo plus pemetrexed/platinum arm in KEYNOTE-189 (un-stratified HR: 1.29; 95% CI: 1.02-1.62). Median PFS in the selected population with ≥5 cycles of pemetrexed in KEYNOTE-189 was 9.3 months (95% CI: 9.0-11.1) in the pembrolizumab plus pemetrexed/platinum arm, and when compared with the placebo plus pemetrexed/platinum arm in KEYNOTE-189, resulted in an un-stratified HR of 0.53 (95% CI: 0.42-0.68). Incidence rates of TEAEs were similar in those 3 selected populations (Table 1).

      table 1_wclc 2019 alimta abstract.jpg

      Conclusion

      In a selected population with pemetrexed maintenance in KEYNOTE-189, the placebo arm showed numerically comparable efficacy with historical data on pemetrexed maintenance. Pemetrexed/platinum in combination with pembrolizumab proved consistent clinical benefit in the same population with ≥5 cycles of pemetrexed, compared to the placebo arm in KEYNOTE-189 and historical controls.

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    PR02 - Press Conference (ID 387)

    • Event: WCLC 2019
    • Type: Press Conference
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 10:30, CC7.1 A&B
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      PR02.02 - Phase 1 Study of Safety, Tolerability, P­­K and Efficacy of AMG 510, a Novel KRAS G12C Inhibitor, Evaluated in NSCLC (ID 3606)

      09:45 - 10:30  |  Presenting Author(s): Ramaswamy Govindan

      • Abstract
      • Slides

      Abstract not provided

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