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M. Bajars
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-078 - Avelumab (MSB0010718C), an Anti-PD-L1 Antibody, Evaluated in a Phase III Trial versus Docetaxel in Patients with Relapsing NSCLC (ID 1588)
09:30 - 09:30 | Author(s): M. Bajars
- Abstract
Background:
The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against multiple cancers. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody currently being investigated in clinical trials. The phase III study (NCT02395172) is an open-label, multicenter trial of avelumab compared with docetaxel in patients with non-small-cell lung cancer (NSCLC) that has progressed after treatment with a platinum-containing doublet.
Methods:
The primary objective of this head-to-head phase III study is to demonstrate superiority defined by overall survival (OS) of avelumab versus docetaxel in patients with locally advanced unresectable, metastatic, or recurrent NSCLC whose tumors express PD-L1 and whose disease has progressed following treatment with a platinum-containing doublet. Approximately 650 eligible patients (ECOG performance status 0-1 at trial entry, tumor archival material or fresh biopsy suitable for PD-L1 expression assessment, histologically confirmed NSCLC, and known-negative ALK mutation status, among other inclusion and exclusion criteria), including 522 patients with PD-L1—positive tumors, will be randomized 1:1 to receive either avelumab at a dose of 10 mg/kg as a 1h intravenous (IV) infusion Q2W or docetaxel at a starting dose of 75 mg/m2 (per label) by IV infusion Q3W. Patients will be stratified according to PD-L1 status. NSCLC histology and EGFR mutation status will be used to define 3 stratified levels for randomization: squamous cell, non-squamous cell/EGFR wildtype, and non-squamous cell/EGFR-activating mutations. Treatment will continue until disease progression, unacceptable toxicity, or any criterion for withdrawal occurs. Responses will be evaluated according to RECIST 1.1 and adjudicated by a blinded independent review committee. In addition to the primary endpoint of OS, secondary endpoints include progression-free survival, best overall response, quality of life assessments, and safety profile. Exploratory endpoints include duration of response, tumor shrinkage in target lesions per timepoint, immunogenicity, PK profile, and evaluation of molecular, cellular, and soluble markers in peripheral blood or tumor tissue that may be relevant to the mechanism of action of, or response/resistance to, avelumab. Safety profiling of trial drugs includes incidence of adverse events (AEs), serious AEs, and other assessments according to NCI-CTCAE v4.03. Patients receiving avelumab who have achieved a complete response (CR) will be treated for a minimum of 6 months and a maximum of 12 months after confirmation. In the case of relapse following a CR, treatment with avelumab may be re-initiated once at the discretion of the investigator and in the absence of treatment-related toxicity. For patients whose disease progresses with avelumab, treatment may continue past the initial determination of disease progression per RECIST 1.1 if the patient’s performance status has remained stable, other criteria are fulfilled, and the investigator’s opinion supports a possible benefit of continued treatment with avelumab. Patients treated with docetaxel may not crossover to the avelumab arm as long as the primary endpoint has not been met in the planned interim or final analyses. Enrollment in this trial began in April 2015. *Proposed INN.
Results:
not applicable
Conclusion:
not applicable
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P3.01-084 - Avelumab (MSB0010718C), an Anti-PD-L1 Antibody, Evaluated in a Phase Ib Trial as a First-Line Treatment for Patients with Metastatic NSCLC (ID 1707)
09:30 - 09:30 | Author(s): M. Bajars
- Abstract
Background:
The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against multiple cancers. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody currently being investigated in clinical trials. The phase Ib study (NCT01772004) is an open-label, parallel group expansion trial in patients with metastatic or locally advanced solid tumors that includes a cohort of patients with non-small-cell lung cancer (NSCLC) who have not been previously treated for metastatic or recurrent disease. Prior to adding this first-line cohort, this study had enrolled a separate cohort of patients with NSCLC who had received a prior platinum-containing doublet regimen.
Methods:
This trial cohort is enrolling patients with histologically confirmed stage IV (according to IASLC) or recurrent NSCLC who have not previously received treatment for metastatic or recurrent disease. In addition, this cohort is restricted to patients without an activating EGFR mutation or ALK rearrangement. Patients with unknown EGFR or ALK status will be tested during screening and are required to have negative status for inclusion. Eligible patients also must have tumor archival material or fresh biopsy, an ECOG performance status of 0 or 1 at the time of trial entry, and disease with at least 1 measurable lesion according to RECIST 1.1. Exclusion criteria include prior therapy with immune checkpoint drugs or a known history of autoimmune disease. Up to 150 eligible patients will receive avelumab at 10 mg/kg as an infusion Q2W. Treatment will continue until disease progression, unacceptable toxicity, or any criterion for withdrawal occurs. Treatment may be continued despite progression according to RECIST 1.1 if the patient’s clinical status is stable and, according to investigator opinion, there is no need to start salvage therapy. The primary objective of the trial is to assess the safety and tolerability of avelumab as a first-line therapy. Select secondary objectives include: assessment of best overall response (BOR) and progression-free survival (PFS) according to RECIST 1.1; assessment of immune-related BOR and immune-related PFS (using modified Immune-Related Response Criteria); and assessment of overall survival. Association between tumor PD-L1 expression and efficacy will be evaluated. Immunomonitoring of cellular and soluble markers and intratumoral cellular surveillance will also be carried out. At each visit during the treatment phase, adverse events will be assessed and graded according to NCI-CTCAE v4.0. Tumor evaluation will be performed every 6 weeks until progression. Enrollment in this cohort began in March 2015. *Proposed INN.
Results:
not applicable
Conclusion:
not applicable
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P3.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 226)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.08-011 - Avelumab (MSB0010718C), an Anti-PD-L1 Antibody, Evaluated in a Phase Ib Trial in Patients with Advanced Mesothelioma (ID 790)
09:30 - 09:30 | Author(s): M. Bajars
- Abstract
Background:
The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against multiple cancers. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody currently being investigated in clinical trials. The phase Ib study (NCT01772004) is an open-label, parallel group expansion trial in patients with metastatic or locally advanced solid tumors that includes a cohort of patients with advanced, unresectable mesothelioma.
Methods:
This trial cohort is enrolling patients with histologically or cytologically confirmed unresectable mesothelioma (pleural or peritoneal) that has progressed after treatment with either a platinum-pemetrexed–containing regimen or a platinum-based regimen followed by pemetrexed (or vice versa). Eligible patients must have available tumor archival material or fresh biopsy, and an ECOG performance status of 0 or 1 at trial entry, and disease with at least 1 measurable lesion that has not been irradiated. Exclusion criteria include prior therapy with immune checkpoint drugs, a known history of autoimmune disease, or recent anticancer treatment (within the 28 days prior to study start). Up to 50 eligible patients will receive avelumab at 10 mg/kg as an infusion Q2W. Treatment will continue until disease progression, unacceptable toxicity, or any criterion for withdrawal occurs. Treatment may be continued despite progression according to RECIST 1.1 if the patient’s clinical status is stable and, according to investigator opinion, there is no need to start salvage therapy. The primary objective of the trial is to assess the safety and tolerability of avelumab. Select secondary objectives include: assessment of best overall response (BOR) and progression-free survival (PFS) according to RECIST 1.1; assessment of immune-related BOR and immune-related PFS (using the modified Immune-Related Response Criteria); and assessment of overall survival. Association between tumor PD-L1 expression and efficacy will be evaluated. Changes in soluble factors and immune cell profiling will be characterized and immunomonitoring will occur at each visit. Tumor assessments will be performed every 6 weeks until progression. Tumor tissue from the most recent biopsy or surgical specimen will be collected prior to the initiation of trial treatment, and fresh biopsies may be optionally collected on day 43 and at the end-of-treatment visit. At each visit during the treatment phase, adverse events will be assessed and graded according to NCI-CTCAE v4.0. Enrollment in this study began in September 2014. *Proposed INN.
Results:
not applicable
Conclusion:
not applicable
