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H. Kida
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-027 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR Study) (ID 8490)
09:30 - 09:30 | Author(s): H. Kida
- Abstract
Background:
The study objective was to compare efficacy and safety of CBDCA+PTX+BEV and CDDP+PEM+BEV in non-squamous (non-Sq) NSCLC patients.
Method:
Treatment-naïve patients aged 20-74 with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC were randomly assigned at 1:2 ratio to either treatment A (4 cycles of CBDCA [AUC 6] + PTX [200mg/m[2]] + BEV [15mg/kg] q3wk, and maintenance therapy with BEV q3wk until progression) or treatment B (4 cycles of CDDP [75mg/m[2]] + PEM [500mg/m[2]] + BEV q3wk, and maintenance therapy with PEM + BEV until progression). The primary endpoint was PFS by central review. The secondary endpoints included OS and safety profile. Target enrollment number was 210.
Result:
A total of 55 sites across Japan enrolled 199 patients: 67/132 (A/B). The median age was 67/66 years, 70%/74% were male, 54%/52% were PS 0, 75%/73% were stage IV and 93%/98% had adenocarcinomas. As of April 14, 2017, patients had completed a median of 7/8 treatment cycles, while 94%/80% had discontinued treatment. The most common ≥G3 adverse events were neutropenia (75%/24%), and hyponatraemia (6%/10%). The most common BEV-related adverse events (≥G1) were hypertension (44%/58%), proteinuria (52%/43%) and epistaxis (26%/14%). Dose reduction was necessary due to an adverse event in 31%/22% patients. Treatment-related death (pulmonary infection) was reported in 1 patient receiving treatment B.
Conclusion:
CBDCA+PTX+BEV and CDDP+PEM+BEV had different safety profiles. Efficacy results including the primary endpoints will be presented in 2018.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-009 - Monitoring Nivolumab Binding as a Method to Clarify the Residual Therapeutic Effects in Previously Treated Lung Cancer Patients (ID 8098)
09:30 - 09:30 | Author(s): H. Kida
- Abstract
Background:
Although the biological durability of Nivolumab, the PD-1 blocking antibody, was reported to continue longer than 12 weeks, the maximum duration of its efficacy, along with toxicity, after discontinuation and the correlation between residual binding and clinical events in cases of sequential therapeutic regimens remain unclear.
Method:
Peripheral blood, pleural effusion and bronchoalveolar lavage fluid were obtained from non-small cell lung cancer patients previously treated with Nivolumab. To evaluate the efficacy of the treatment, we developed a simple technique to identify Nivolumab binding status — complete binding, partial binding and no binding — in T cells from patient samples using flowcytometry, which can also be used to obtain T cell differentiation markers and transcriptome profiles, particularly in the Nivolumab bound T cell population. Based on this method, we tracked the binding status in T cells primarily from peripheral blood in patients who received a sequential therapeutic regimen after Nivolumab treatment.
Result:
While the decrease in frequency of Nivolumab binding after discontinuation was observed in all cases where long term monitoring was possible, Nivolumab binding in T cells from peripheral blood was detected until more than 20 weeks, though effective binding could have ceased before that time point. We found that the direct effects on Nivolumab binding via sequential treatment were limited. Finally, we observed in clinical cases that our monitoring technique was also helpful in understanding the cause of clinical events and its residual efficacy in patients who previously received Nivolumab.
Conclusion:
Monitoring of Nivolumab binding to T cells after discontinuation can be valuable when planning sequential therapeutic regimens in the following ways: estimating the potential residual efficacy, predicting the risk of immune-related adverse events and the time of relapse due to complete loss of efficacy, and investigating the changes in the immune profile in Nivolumab bound T cells.
