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Naiyer A Rizvi



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    EX04 - Mini Oral Abstract Session - MA08.06, MA18.02, MA19.02, MA20.11 (ID 1006)

    • Event: WCLC 2018
    • Type: Exhibit Showcase
    • Track: Advanced NSCLC
    • Presentations: 1
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      EX04.03 - Prior Therapy and Increased Expression of PD-L1 in NSCLC Tumor Samples (ID 11881)

      10:05 - 10:10  |  Author(s): Naiyer A Rizvi

      • Abstract
      • Slides

      Background

      Tumor PD-L1 expression has been shown to enrich for response to immunotherapy in several indications, including advanced NSCLC. However, the stability of PD-L1 expression over time and its relationship with non-immunotherapy cancer treatment is currently uncertain. We hypothesized that prior chemotherapy or radiotherapy would increase PD-L1 expression.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In the Phase 2, open-label, single-arm durvalumab ATLANTIC study (NCT02087423), patients who had received ≥2 prior systemic regimens in the treatment of Stage IIIB or IV NSCLC were screened for tumor PD-L1 expression by immunohistochemistry using the VENTANA PD-L1 (SP263) Assay (25% tumor cell [TC] cutoff). PD-L1 expression was assessed using either a recent (<3 months) or archival sample; a subset of patients provided both. The relationship between non-immunotherapy cancer treatment and prevalence of tumor PD-L1 expression ≥25% (TC≥25%) was assessed in patients who received therapy prior to sample acquisition versus those who did not. Pearson’s chi-squared test was used to examine the differences between patient subgroups.

      4c3880bb027f159e801041b1021e88e8 Result

      Of the patients screened for participation in ATLANTIC, 1590 were successfully assessed for PD-L1 expression. PD-L1 TC≥25% prevalence was higher in patients who had received prior radiotherapy or chemotherapy before sample acquisition, with prevalence noticeably higher in those who had received ≥2 lines of prior chemotherapy. Prior EGFR inhibitor treatment did not have any noticeable relationship to TC≥25% prevalence (Table). In the subset of patients with paired recent and archival samples, TC≥25% prevalence remained the same in 74% of cases, increased over time in 19.5%, and decreased in 6.5%.

      Treatment regimen

      Subgroup (n)

      PD-L1 TC≥25% prevalence (%)

      P-value

      Prior tyrosine kinase inhibitor (TKI)

      No prior TKI (607)

      39.9

      0.947

      Prior TKI (411)

      39.7

      Prior EGFR inhibitor (379)

      38.5

      0.154

      Prior ALK inhibitor (15)

      60.0

      Prior chemotherapy

      No prior chemotherapy (145)

      29.0

      0.004

      Prior chemotherapy (873)

      41.6

      Number of lines of prior chemotherapy

      0 (155)

      29.0

      0.031

      1 (10)

      30.0

      2 (138)

      42.8

      >2 (725)

      41.5

      Prior radiotherapy

      No prior radiotherapy (599)

      37.1

      0.034

      Prior radiotherapy (419)

      43.7

      8eea62084ca7e541d918e823422bd82e Conclusion

      PD-L1 expression may increase in response to chemotherapy or radiotherapy and is unlikely to decrease over time. Re-biopsy may provide a more accurate assessment of current tumor PD-L1 expression status when a low/negative result is seen in an archival sample, particularly if the patient has received multiple lines of intervening radiotherapy or chemotherapy.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    MS14 - IO in Early Stage NSCLC (ID 793)

    • Event: WCLC 2018
    • Type: Mini Symposium
    • Track: Immunooncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 107
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      MS14.05 - Do Biomarkers used in Metastatic Setting Apply in Earlier Stages (ID 11462)

      11:30 - 11:45  |  Presenting Author(s): Naiyer A Rizvi

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • 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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      P1.01-21 - Safety of Durvalumab Retreatment in Advanced NSCLC Patients Who Progressed Following Initial Disease Control In ATLANTIC (ID 12386)

      16:45 - 18:00  |  Author(s): Naiyer A Rizvi

      • Abstract
      • Slides

      Background

      In ATLANTIC, patients who completed a year of durvalumab (anti-PD-L1) treatment but later progressed off therapy were eligible for retreatment. We evaluated safety in these patients compared with the overall study population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      ATLANTIC (NCT02087423) was a Phase 2, open-label, single-arm trial in patients with Stage IIIB–IV NSCLC who had received ≥2 prior systemic treatment regimens, including one platinum-based. The study included three independent cohorts. In C1 (EGFR+/ALK+) and C2 (EGFR−/ALK−), enrollment was enriched for patients with ≥25% of tumor cells (TC) expressing PD-L1, while patients in C3 (EGFR−/ALK−) only had PD-L1 TC ≥90%. Patients received durvalumab 10 mg/kg q2w for ≤12 months. Patients who achieved and maintained disease control but then progressed after completing the initial 12-month treatment period were offered retreatment for a maximum of 12 months of further treatment. Safety and tolerability was a secondary outcome.

      4c3880bb027f159e801041b1021e88e8 Result

      As of November 7, 2017, of 442 patients in the ATLANTIC full analysis set, 102 (23.1%) had completed 12 months of initial treatment and 95 (21.5%) had disease control at the end of initial treatment. A total of 40 patients started retreatment. The median actual duration of exposure to durvalumab was 16.0 weeks (range 1–62; 40.1% of patients on treatment for ≥24 weeks) during initial treatment and 18.1 weeks (range 2–52; 37.5% of patients on retreatment for ≥24 weeks) during retreatment. The table shows safety during initial treatment and retreatment.

      Initial treatment (n=444)

      Retreatment phase (n=40)

      Cohort,* n (%)

      C1 (EGFR+/ALK+)

      111 (25.0)

      7 (17.5)

      C2 (EGFR−/ALK−)

      265 (59.7)

      26 (65.0)

      C3 (EGFR−/ALK−; TC ≥90%)

      68 (15.3)

      7 (17.5)

      Any TRAE, n (%)

      256 (57.7)

      19 (47.5)

      Grade ≥3 TRAEs

      42 (9.5)

      6 (15.0)

      TRAEs leading to death

      0

      2 (5.0)

      Serious TRAEs

      28 (6.3)

      4 (10.0)

      TRAEs leading to discontinuation

      10 (2.3)

      4 (10.0)

      Safety analysis set. *A more detailed analysis of exposure and safety by cohort will be presented. Causes of death were: pneumonitis and respiratory failure; cardiac arrest. TRAE=treatment-related adverse event.

      8eea62084ca7e541d918e823422bd82e Conclusion

      A large proportion of patients (37.5%) maintained retreatment for ≥24 weeks, suggesting that patients who originally completed 12 months of treatment can tolerate sustained retreatment. The tolerability profile of durvalumab upon retreatment was similar to that seen during initial treatment, although there were two treatment-related deaths during the retreatment phase. Retreatment with anti-PD-L1 may be feasible for selected patients with NSCLC who demonstrate original benefit and progress off therapy.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-33 - Open-Label, Biomarker-Directed Platform Study in NSCLC Patients Who Progressed on an Anti-PD-(L)1 Containing Therapy (HUDSON) (ID 13743)

      16:45 - 18:00  |  Author(s): Naiyer A Rizvi

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitor (ICI)-containing regimens have significantly improved survival outcomes in first- and second-line NSCLC. However, the majority of patients do not respond or have non-durable responses to anti-programmed cell death-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) containing therapy (primary resistance) or progress during anti-PD-1/PD-L1 containing therapy (acquired resistance). HUDSON addresses the urgent need to identify treatments and understand ICI resistance for this emerging ICI-resistant population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      HUDSON is a multi-centre, international multi-arm umbrella study that will 1) evaluate therapies to reverse ICI resistance and 2) define mechanisms of ICI resistance in NSCLC patients who have progressed following standard-of-care platinum and ICI-based therapies. HUDSON is a platform study that consists of two groups; a biomarker matched and a biomarker non-matched group. Within the biomarker matched group, different cohorts will test 1) homologous recombination repair (HRR) defects and 2) LKB1 aberration for response to durvalumab and olaparib (PARP inhibitor), 3) ATM deficiency for response to durvalumab and AZD6738 (ATR inhibitor) and 4) RICTOR amplification for response to durvalumab and vistusertib (mTORC1/2 inhibitor). In the biomarker non-matched group, cohorts will test durvalumab in combination with either i) olaparib, ii) AZD9150 (STAT3 inhibitor) or iii) AZD6738, in patients with primary and acquired resistance to a prior ICI. Allocation to a cohort is informed by the tumour molecular profile according to a pre-specified assignment algorithm. New cohorts will be added as new translational hypotheses are established. Translational research will be performed on serial peripheral blood samples (including ctDNA) and tumour biopsies. HUDSON enrols ICI-resistant patients in a signal searching manner. Biomarker matched and non-matched groups will be opened simultaneously, and all eligible patients can be allocated a treatment option irrespective of their tumour profile. Enrolment is ongoing, clinical trial information: NCT03334617.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 966)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.17-27 - IMpower030: Phase III Study Evaluating Neoadjuvant Treatment of Resectable Stage II-IIIB NSCLC with Atezolizumab + Chemotherapy (ID 12087)

      16:45 - 18:00  |  Presenting Author(s): Naiyer A Rizvi

      • Abstract
      • Slides

      Background

      A standard of care for resectable early-stage non-small cell lung cancer (NSCLC) is surgery alone or in combination with adjuvant or neoadjuvant platinum-based doublet chemotherapy (PT-DC). Nevertheless, 30%-70% of patients develop recurrence and die due to disease progression, highlighting the unmet need for more efficacious treatment regimens. Atezolizumab, an anti–programmed death-ligand 1 (anti–PD-L1) antibody that reinvigorates the anti-cancer immune response, has shown efficacy as monotherapy and in combination with chemotherapy in advanced NSCLC. On the basis of this activity, it is thought that the combination of atezolizumab and PT-DC may provide clinical benefit in the neoadjuvant setting by enhancing cancer cell killing and eradicating micro-metastases prior to surgery, thereby reducing the risk of disease recurrence. The objective of IMpower030 (NCT03456063) is to evaluate the efficacy and safety of atezolizumab in combination with PT-DC as neoadjuvant treatment for patients with resectable early-stage NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      IMpower030 is a global, Phase III, multicenter, double-blind, randomized study in patients with histologically or cytologically confirmed, resectable stage II, IIIA, or select IIIB (T3N2) NSCLC (per AJCC/UICC, 8th ed). Study inclusion requires measurable disease per RECIST v1.1, ECOG PS of 0/1, and eligibility for R0 resection with curative intent and PT-DC. Patients who have received prior therapy for lung cancer or who present with non-squamous NSCLC with activating EGFR mutations or ALK translocation are excluded. Approximately 302 patients will be randomized to receive 4 cycles of neoadjuvant atezolizumab (1200 mg Q3W, Arm A) or placebo (Arm B) in combination with an investigator-selected PT-DC regimen. Following surgical resection and pathology response assessment, treatment assignment will be unblinded; patients in Arm A will receive adjuvant treatment with atezolizumab for up to 16 cycles or until disease recurrence or unacceptable toxicity, whereas patients in Arm B will receive best supportive care and scheduled observational follow-up. The primary efficacy endpoint is major pathological response, defined as ≤ 10% residual viable tumor tissue at time of resection as assessed by an independent central pathology laboratory. Secondary efficacy endpoints include OS, ORR, investigator-assessed event-free survival and disease-free survival per RECIST v1.1, pathological complete response and patient-reported outcomes. Exploratory biomarkers will also be evaluated.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      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: 4
    • 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  |  Presenting Author(s): Naiyer A Rizvi

      • 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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      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  |  Presenting Author(s): Naiyer A Rizvi

      • 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 &lt;50% (ID 13347)

      12:00 - 13:30  |  Presenting Author(s): Naiyer A Rizvi

      • 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  |  Presenting Author(s): Naiyer A Rizvi

      • 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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