| Primary | Pathologic Complete Response (pCR) Rate (%) Overall | The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.
- T0: No evidence of primary tumor.
- N0: Cancer has not spread to nearby lymph nodes.
An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Primary | pCR Rate (%) by Baseline Histologic Subgroup | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Primary | pCR Rate (%) by Baseline Tumor Location Subgroup | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Primary | pCR Rate (%) by Steroid Use Subgroup | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Primary | pCR Rate (%) by Surgery Subgroup | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. The subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks * 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Rate (%) of R0 Resection Overall | R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Rate (%) of R0 Resection by Baseline Histologic Subgroup | R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Number | | percentage of participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Pathologic Stage at Time of Surgery | Pathologic staging was assessed via ypTNM (after chemoRT and surgery):
- Tumor Stage (TX, T0, T1, T1a, T1b, T2, T3, T4, T4a, T4b) refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it had grown into the wall of the esophagus.
- Node Stage (NX, N0, N1, N2, N3) refers to the number and location of lymph nodes that cancer has spread to. The higher the number after the N, the more lymph nodes that contained cancer cells.
- Metastasis Stage (M0, M1) refers to whether the cancer had not spread (M0) or spread (M1) to other parts of the body.
- Stage group (0, I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IV, IVA, IVB) are based on the TNM stages detailed above. The higher the number, the more advanced the cancer was.
For each category, a lower stage/group represents a better outcome. | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. | Posted | | Count of Participants | | Participants | | At time of surgery, up to a maximum of 261 days | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6. | Posted | | Count of Participants | | Participants | | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6. | Posted | | Count of Participants | | Participants | | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). | Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6. | Posted | | Count of Participants | | Participants | | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events which started on or after the first infusion of study treatment (Carboplatin/Paclitaxel/Sotigalimab/Radiotherapy) until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first. Laboratory values that were considered clinically significant were reported as adverse events. | Safety Population: All participants who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Sotigalimab With SOC ChemoRT | Participants received SOC chemoRT, consisting of:
- External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
- Carboplatin (AUC = 2) and paclitaxel (50 mg/m^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT). Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. |
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