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Sandip Patel



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    OA05 - Clinical Trials in IO (ID 899)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
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      OA05.02 - Epacadostat Plus Pembrolizumab in Patients with Non-Small Cell Lung Cancer: Phase 1/2 Results from ECHO-202/KEYNOTE-037 (ID 13535)

      13:40 - 13:50  |  Author(s): Sandip Patel

      • Abstract
      • Presentation
      • Slides

      Background

      Epacadostat (E) is a potent, highly selective inhibitor of the indoleamine 2, 3-dioxygenase 1 (IDO1) enzyme. ECHO-202/KEYNOTE-037 is an open-label, phase 1/2 study of E + pembrolizumab (P) in patients (pts) with advanced tumors (NCT02178722). We report updated efficacy and safety data for the phase 1 and 2 non-small cell lung cancer (NSCLC) cohort as of 8 Jan 2018 data cutoff.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Adult pts with prior platinum-based therapy (tx), no prior immune checkpoint inhibitors, and those intolerant to EGFR-targeted therapy were eligible. Pts could receive E (25, 50, 100, or 300 mg twice daily [BID]) + P (2 mg/kg or 200 mg every 3 weeks [Q3W]) during phase 1; maximum tolerated dose was not achieved. E (100 mg BID) + P (200 mg Q3W) tx doses were selected for phase 2 evaluation. Efficacy was assessed by RECIST v1.1 criteria. Programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) was evaluated using the 22C3 pharmDx assay. IDO1 status was measured by RNAScope. Safety was assessed in pts receiving ≥1 E + P dose.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 70 pts (phase 1, n=12; phase 2, n=58) were evaluated. Median age was 63 years and 57% of pts were female. EGFR mutation status (+/-/not available) was 10%/71%/19%; KRAS status was 19%/26%/56%, respectively. Most pts had adenocarcinoma (70%), a history of smoking (76%), and 0–1 prior lines of tx (64%). PD-L1 TPS results were available in 55/70 pts; IDO1 status (+/-) in 41/70 pts. Overall, the objective response rate (ORR; complete response [CR] + partial response [PR]) and disease control rate (CR + PR + stable disease [SD]) were 29% (20/70; 17 PR) and 50% (35/70; 15 SD), respectively. ORR was 22% (2/9) in pts with TPS ≥50% and 0–1 prior tx; for pts with TPS <50% and 0–1 prior tx, ORR was 22% (5/23). ORR for pts with IDO1+ and IDO1- tumors were 24% (6/25) and 19% (3/16), respectively. At data cutoff, 10/20 responses were ongoing. Median progression-free survival (PFS) was 4.0 mo (90% confidence interval, 2.1–6.2 mo); PFS rates at 6, 12, and 18 mo were 43% (33%–53%), 31% (22%–40%), and 17% (10%–26%), respectively. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 27% of pts; 3 pts discontinued due to TRAEs; and no TRAEs led to death.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The E + P combination was generally well tolerated and associated with promising responses in pts with NSCLC.

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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-03 - Ensartinib Treatment Beyond Disease Progression in Stage IV ALK+ Non-Small Cell Lung Cancer (ID 13293)

      16:45 - 18:00  |  Author(s): Sandip Patel

      • Abstract
      • Slides

      Background

      Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC) patients (pts) benefit from receiving ALK tyrosine kinase inhibitors (TKIs); however, despite initial activity, resistance invariably develops. Disease progression (PD) is sometimes limited to progression which occurs in only one or a few sites and may not occur systemically. Local treatment with radiation while continuing treatment with ensartinib may enable prolonged benefit beyond progression.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients who were ALK TKI naïve or had received prior ALK treatment received ensartinib 225mg QD until PD or unacceptable toxicity or investigator discretion. The primary endpoint was safety and tolerability, and the secondary endpoint was pharmacokinetic and preliminary biological activity. Tumor assessment was performed locally every 8 weeks. Post-progression treatment with ensartinib was allowed if the investigator felt the patient was still receiving benefit from ensartinib. Cycles were approximately every 28 days, and radiation therapy after Cycle 1 for isolated CNS metastases was permitted if there was no evidence of progressive disease elsewhere. Post-progression treatment data were captured and analyzed.

      4c3880bb027f159e801041b1021e88e8 Result

      As of the data cut-off (May 01, 2018), 12 pts with progression continued ensartinib treatment post progression (67% with progression only in the CNS, 75% of which had CNS lesions at baseline and 33% with progression only outside the CNS). Of the 12 pts, half of the patients were ALK TKI naïve and half had received at least one prior ALK TKI. Six pts received radiation therapy at the time of initial progression. The initial median Progression Free Survival (PFS) of the 12 pts with post progression treatment was 15.7 months and median secondary PFS (date of initial progression to the date of second progression or end of treatment) was 5.7 months for a combined duration of therapy of 23.8 months. A significantly longer duration of continued therapy was observed in patients who received radiation treatment than those who did not 8.6 mos vs 3.5 mos. The secondary PFS was longer in treatment naïve pts than in pts who received a prior ALK TKI, 7.7 mos vs 5 mos. After the initial progression, excluding lesions treated with radiation therapy, secondary stable disease was observed in 92% of patients. No new or additional safety risk was identified in the pts post progression.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Ensartinib may have clinical benefit in selected patients with NSCLC if continued post-progression. Secondary PFS was longer in patients treated with radiation therapy. Ensartinib was generally well tolerated in these patients treated post progression.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.04-23 - Phase 1b/2 Study to Evaluate Novel Combinations With Oleclumab (MEDI9447) in Previously Treated Advanced EGFRm NSCLC (ID 12300)

      12:00 - 13:30  |  Author(s): Sandip Patel

      • Abstract
      • Slides

      Background

      Patients with mutant EGFR (EGFRm) non–small cell lung cancer (NSCLC) have a limited chance of benefiting from treatment with programmed death-1 inhibitors. EGFR activation leads to overexpression of CD73 and may provide a mechanism of immune evasion. CD73 overexpression has also led to worse outcomes in multiple tumor types, including NSCLC. Recent studies demonstrated that an orthogonal therapeutic approach to cancer, such as combining tyrosine kinase inhibitors (TKIs) with immunotherapy, may result in synergistic clinical activity. Oleclumab is a human monoclonal antibody (mAb) that selectively binds to CD73 and inhibits the enzymatic production of adenosine. Adenosine exerts its immunosuppressive effects on various immune cells via the adenosine 2A receptor (A2AR). AZD4635 is a potent, selective A2AR antagonist that inhibits this signaling pathway. Osimertinib is a potent and selective inhibitor of EGFRm, including the T790M resistance mutation. We hypothesize that novel combinations of targeted and immunotherapeutic agents targeting the adenosine pathway will be well tolerated and lead to increased antitumor activity in subjects with EGFRm NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a multi-arm, open-label, multicenter, phase 1b/2 study (NCT03381274) consisting of 2 parts. In Part 1, the safety and tolerability of oleclumab in combination with either osimertinib (Arm A) or AZD4635 (Arm B) will be evaluated, and a recommended phase 2 dose for each combination will be identified. In Part 2, the safety, tolerability, and preliminary antitumor activity will be evaluated. In both parts, patients will be allocated to treatment arms based upon their EGFRm status and their prior therapy. For Part 2, the primary objective of antitumor activity will be assessed by objective response according to RECIST v1.1. Key secondary objectives include additional evaluation of clinical activity, the pharmacokinetic profiles of oleclumab, osimertinib, and AZD4635, and the evaluation of oleclumab immunogenicity. Additional treatment arms may be added as the study progresses. The study is open for enrollment and recruitment is ongoing, with a planned enrollment of up to approximately 98 patients.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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