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Petra Rietschel



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    MA04 - Novel Approaches with IO (ID 900)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Immunooncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 107
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      MA04.01 - Cemiplimab, a Human Monoclonal Anti-PD-1, Alone or in Combination with Radiotherapy: Phase 1 NSCLC Expansion Cohorts (ID 13177)

      13:30 - 13:35  |  Author(s): Petra Rietschel

      • Abstract
      • Slides

      Background

      Cemiplimab (REGN2810), a human monoclonal anti-PD-1, has exhibited substantial antitumor activities in patients with advanced malignancies in a first-in-human study. We report interim results of the Phase 1 expansion cohorts (ECs 1 and 2) of cemiplimab, alone or plus radiotherapy, in advanced NSCLC (NCT02383212).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with advanced NSCLC who had relapsed after, or were refractory to, at least, first-line therapy received cemiplimab 200 mg Q2W in EC 1, or cemiplimab 3 mg/kg Q2W plus radiotherapy (9 Gy × 3 times/week 1 week after first dose of cemiplimab) to a single lesion in EC 2. For EC 2, patients were required to have NSCLC for which palliative radiation therapy was indicated. Planned treatment duration was up to 48 weeks in both ECs. The co-primary objectives were to evaluate the safety, tolerability, and efficacy of cemiplimab, alone or plus radiotherapy. Tumor measurements (of non-irradiated lesions) were performed by RECIST 1.1 Q8W.

      4c3880bb027f159e801041b1021e88e8 Result

      As of Sept 1, 2017, 20 patients (13 M/ 7 F; median age 64.0 years [range, 50–82]) and 33 patients (22 M/ 11 F; median age 67.0 years [range, 47–82]) were enrolled in EC 1 and EC 2, respectively. ECOG performance status 1 versus 0 was 80.0% versus 20.0% and 66.7% versus 30.3%, respectively, for ECs 1 and 2, and missing in one in EC 2; 75.0% (EC 1) and 48.5% (EC 2) had received prior radiotherapy. Investigator-assessed overall response rate (ORR; complete response [CR] + partial response [PR]) was 40.0% (1 CR and 7 PRs) and 18.2% (6 PRs) in EC 1 and EC 2, respectively. Disease control rate (ORR + stable disease [SD]) was 60.0% (1 CR + 7 PRs + 4 SDs) and 72.7% (6 PRs + 18 SDs) in EC 1 and EC 2, respectively. The most common treatment-emergent adverse events (TEAEs) of any grade were arthralgia, asthenia, cough, and dyspnea (each 20.0%) in EC 1, and decreased appetite (30.3%), fatigue (27.3%), cough (24.2%), asthenia and back pain (each 21.2%) in EC 2. Grade ≥3 TEAEs occurring in ≥2 patients were pneumonia (10.0%) in EC 1; and anemia (12.1%), hypophosphatemia and urinary tract infection (each 6.1%) in EC 2. One patient in EC 2 experienced TEAE of pneumonitis with an outcome of death, considered related to study drug.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Cemiplimab monotherapy demonstrated substantial antitumor activity in pretreated NSCLC patients. The safety profiles were comparable with other anti-PD-1 agents and radiotherapy.

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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: 3
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.04-24 - EMPOWER-Lung 2: Cemiplimab and Ipilimumab ± Chemotherapy vs Pembrolizumab in Advanced NSCLC with PD-L1 ≥50%, a Phase 3 Study (ID 12706)

      12:00 - 13:30  |  Author(s): Petra Rietschel

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitors have shown clinical activity in multiple tumor types, including NSCLC, which accounts for 80–85% of all lung cancers. Median progression-free survival (PFS) with platinum-based doublet chemotherapy ranges from 2.7–6.4 months. Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, has exhibited antitumor activity and safety in a phase 1 trial of advanced malignancies including NSCLC. Recognizing that NSCLC tumors express PD-L1, combining cemiplimab with other immunotherapies and/or chemotherapy has the potential for a synergistic effect in patients with advanced NSCLC

      a9ded1e5ce5d75814730bb4caaf49419 Method

      EMPOWER-lung 2 (16111) is a randomized (1:1:1), open-label, global, phase 3 study on the efficacy and safety of combinations of cemiplimab, ipilimumab, and platinum-based doublet chemotherapy vs pembrolizumab monotherapy in the first‑line treatment of patients with stage IIIB or stage IV squamous or non-squamous NSCLC with tumors expressing PD-L1 ≥50% (EudraCT 2017-001041-27). Patients who have received prior systemic treatment for their advanced disease will be excluded. Patients will be stratified by histology and randomized into three study arms: Arm A: standard of care pembrolizumab monotherapy for 108 weeks; Arm B: cemiplimab every 3 weeks (Q3W) for up to 108 weeks plus ipilimumab 50mg every 6 weeks (Q6W) (4 doses); Arm C: cemiplimab Q3W for up to 108 weeks plus platinum‑doublet Q3W (2 doses) and ipilimumab 50mg Q6W (4 doses). The primary objective is to evaluate PFS. Key secondary objectives include overall survival and overall response rates. Assuming a median PFS of 10 months for patients treated with pembrolizumab monotherapy and a median PFS of 15 months for patients treated with each of the cemiplimab combination therapies, 585 patients are needed to obtain sufficient PFS events for the analysis of PFS with 90% power to detect statistical significance for each of cemiplimab combination vs pembrolizumab monotherapy comparison. This study is open for enrollment with the first patient’s first visit planned for Q2 2018 and last patient’s last visit planned for Q1 2023.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.04-25 - EMPOWER-Lung 3: A Phase 3 Study of Cemiplimab, Ipilimumab and Chemotherapy in Advanced NSCLC with PD-L1 <50% (ID 13347)

      12:00 - 13:30  |  Author(s): Petra Rietschel

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitors have shown activity in NSCLC, but the benefit is mostly seen in patients with tumor proportion score (TPS) ≥50%. Patients with TPS <50% will likely require a combination therapy approach. Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, has exhibited antitumor activity and safety in a phase 1 trial of advanced malignancies including NSCLC. Based on their unique modes of action, combining cemiplimab with ipilimumab, an anti‑CTLA‑4, and modified platinum‑based chemotherapy has the potential for a synergistic effect in patients with advanced NSCLC with PD-L1 <50%.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      EMPOWER-lung 3 (16113) is a randomized (1:1:1), open-label, global, phase 3 study of the efficacy and safety of combinations of cemiplimab, ipilimumab, and platinum-based doublet chemotherapy in the first-line treatment of patients with advanced or metastatic NSCLC with tumors expressing PD-L1 <50% (NCT03409614). Patients will be stratified by histology and PD-L1 expression level (<1% vs 1–24% vs 25–49%). Treatment arms: Arm A: standard of care platinum‑based doublet chemotherapy every 3 weeks (Q3W) for 4–6 cycles; Arm B: cemiplimab Q3W (up to 108 weeks) plus standard of care platinum-based doublet chemotherapy Q3W for 4–6 cycles; Arm C: cemiplimab Q3W (up to 108 weeks) plus standard of care platinum-based doublet chemotherapy Q3W for two cycles and ipilimumab 50 mg every 6 weeks (up to 4 doses). The primary objective is to evaluate progression-free survival (PFS). Key secondary objectives include overall survival and overall response rate. A total of 690 patients are planned. This assumes a median PFS of 6 months for patients treated with chemotherapy alone and 10 months for patients treated with each of the cemiplimab combination therapies, corresponding to a 66.7% increase in median PFS and a hazard ratio of 0.6. Under these assumptions, the planned enrollment will generate sufficient PFS events for analysis of PFS with 90% power to detect a statistical significant difference for each of cemiplimab combination vs standard of care platinum-based doublet chemotherapy comparison. Enrollment has begun for this study.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.04-26 - EMPOWER-Lung 4: A Phase 2 Study of Cemiplimab Plus Ipilimumab in the Second-Line Treatment of Advanced NSCLC with PD-L1 &lt;50% (ID 13349)

      12:00 - 13:30  |  Author(s): Petra Rietschel

      • Abstract
      • Slides

      Background

      Immunotherapies have been investigated as potential therapeutic approaches to improve survival and quality of life in patients with advanced NSCLC. With monotherapy PD-1 blockade, the greatest benefit was seen in patients with tumor proportion score (TPS) of PD-L1 immunoreactivity of ≥50%. Patients with TPS <50% will likely require a combination approach. Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, has exhibited antitumor activity and safety in a phase 1 trial of advanced malignancies including NSCLC. Combination of cemiplimab with other therapies may improve overall response rate (ORR) in patients with advanced NSCLC whose tumor have TPS <50%.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      EMPOWER-lung 4 (1763) is a randomized (1:1:1), open-label, global, phase 2 trial of the efficacy and safety of high-dose (HD) vs standard-dose (SD) cemiplimab in combination with ipilimumab vs SD cemiplimab in the second-line treatment of patients ≥18 years old with advanced NSCLC with tumors expressing PD-L1 <50% (NCT03430063). Patients will be stratified by histology and PD-L1 expression level (<1% vs 1–49%), and randomized to Arm A: SD cemiplimab every 3 weeks (Q3W); Arm B: SD cemiplimab Q3W in combination ipilimumab 50 mg every 6 weeks (up to 4 doses); or Arm C: HD cemiplimab Q3W. Patients will receive cemiplimab for up to 108 weeks or until progression. The primary objective is to evaluate ORR (complete response + partial response) based on RECIST v1.1 assessed by blinded independent review committee. Key secondary objectives include the assessment of overall survival, progression-free survival, and safety/tolerability of the study drugs. Assuming an ORR of 10% in Arm A and 30% in each of Arm B and Arm C, 201 patients (67 per Arm) will yield an 80% power to detect a statistically significant difference for HD or SD cemiplimab in combination with ipilumimab vs SD cemiplimab. This study is open for enrollment with the first patient’s first visit planned for Q2 2018 and the last patient’s last visit planned for Q4 2021.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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