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M. Pless
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MA13 - Modern Technologies and Biological Factors in Radiotherapy (ID 395)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Radiotherapy
- Presentations: 1
- Moderators:M. Thomas, P. Mitchell
- Coordinates: 12/06/2016, 16:00 - 17:30, Stolz 1
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MA13.08 - Discussant for MA13.05, MA13.06, MA13.07 (ID 6953)
16:42 - 16:54 | Author(s): M. Pless
- Abstract
- Presentation
Abstract not provided
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-004 - Second-line Therapy Improves Overall Survival in Primary Refractory Non Small-Cell Lung Cancer (NSCLC) Patients (ID 6114)
14:30 - 14:30 | Author(s): M. Pless
- Abstract
Background:
The effect of palliative chemotherapy for non-small cell lung cancer (NSCLC) is well established. However, little is known on the efficacy of cytotoxic chemotherapy in patients whose tumors are refractory to first-line chemotherapy. We analyzed the outcome of all consecutive and unselected patients receiving palliative chemotherapy in a single institution to assess the efficacy of second-line chemotherapy in primary refractory NSCLC.
Methods:
462 consecutive patients with palliative treatment for NSCLC at the University Hospital Basel between 1990 and 2009 were analyzed. Measured outcomes were overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Patients with progressive disease (PD) as best response to first-line treatment were compared to patients with stable disease (SD), partial (PR) or complete remission (CR). Chi-square test was used for discrete, and Mann Whitney U tests for continuous variables, respectively. Probabilities of survival were calculated using the Kaplan-Meier estimator. The log-rank test was used for comparing groups.
Results:
Median age was 63 years, 71% were male, 81% were smokers and 53% had adenocarcinoma. Median OS of the whole cohort was 11.3 months. 62.3% of patients were treated with a platinum-based (48.3% cisplatin-based) first-line therapy. Median PFS for first-line therapy was 3.0 months. 192 patients (41.6%) were primary refractory on first-line therapy. Median OS was significantly shorter for refractory patients compared to patients with CR, PR or SD (9.2 vs. 14.5 months, p<0.0001). Poorer initial performance status was significantly associated with primary refractory disease (p=0.015). All other baseline characteristics did not differ between refractory and responding patients. 67 (35%) primary refractory patients received a second-line therapy. The clinical benefit rate (CR+PR+SD) from second-line therapy was lower in primary refractory patients (33.9% vs. 43.5%, p=0.023). Median PFS for second-line therapy was shorter for primary refractory patients (2.2 vs. 4.6 months, p=0.26). Median OS was significantly longer for refractory patients receiving second-line chemotherapy vs. best supportive care (13.6 vs. 5.5 months, p<0.0001).
Conclusion:
More than 40% of patients are primary refractory to palliative first-line therapy. These patients have a poor prognosis. However, active second-line chemotherapy can significantly improve the outcome compared to best supportive care. Median OS for patients receiving second-line chemotherapy was close to patients with initial response or stable disease. Patients with primary refractory NSCLC should be offered further active therapy. These real life data for primary refractory patients form the basis against which immunotherapies, the current standard second line treatment, can be compared.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-091 - Final Phase Ib Results of RNActive® Cancer Vaccine BI 1361849 and Local Radiation as Maintenance Therapy for Stage IV NSCLC (ID 4735)
14:30 - 14:30 | Author(s): M. Pless
- Abstract
Background:
Preclinical studies demonstrated that local radiotherapy (RT) acts synergistically with RNActive[® ]vaccines to increase tumor-infiltrating immune cells and enhance anti-tumor effects. BI 1361849 (CV9202) is an immunotherapeutic cancer vaccine comprising optimized mRNA constituents (RNActive[®]) encoding six NSCLC-associated antigens. Here we report clinical outcomes and immune response data of a phase Ib study, employing local RT and BI 1361849 in advanced NSCLC.
Methods:
Patients (Pts) with stage IV NSCLC and a response or stable disease after first-line chemotherapy or therapy with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) were enrolled in three cohorts based on histological and molecular NSCLC subtypes (non-squamous vs. squamous vs. EGFR-mutated NSCLC). Pts received two initial vaccinations with BI 1361849 prior to local RT to the primary tumor or a metastatic lesion (four consecutive daily fractions of 5 Gy), followed by further vaccinations until start of another treatment. Maintenance Pemetrexed (mP) and EGFR-TKIs were continued according to the label. Primary endpoint was safety; secondary endpoints included objective response, PFS and OS. Cellular and humoral immune responses were measured ex vivo by multifunctional intracellular cytokine staining, IFN-γ ELISpot, and ELISA in pre- and post-treatment blood samples.
Results:
26 pts were enrolled. 15 pts received mP, two received EGFR TKIs. Most frequent AEs were mild to moderate injection-site reactions and flu-like symptoms. Two pts experienced BI 1361849-related grade 3 AEs (fatigue, pyrexia). No BI 1361849-related SAE or grade 4 AE was reported. Interim results indicate one confirmed PR in a patient receiving mP and SD in 13/25 evaluable pts (52%, 8 pts on mP, 3 pts without maintenance therapy, 2 pts on EGFR-TKI), with two pts showing remarkably long-lasting disease stabilization of up to 72 and 54 weeks, respectively. Shrinkage of lesions outside the irradiated field of ≥15% occurred in 7 pts, all but one receiving mP. Longitudinal assessment of tumor response allows for further insight into patterns of progression. BI 1361849 was capable of eliciting antigen-specific immune responses in the majority of the patients including both cellular and humoral immune responses.
Conclusion:
BI 1361849 elicits antigen-specific immune responses and can be safely combined with local RT and mP treatment. Shrinkage of non-irradiated lesions and prolonged disease stabilization was observed in a subset of pts, mainly in combination with mP. Final clinical outcomes and analyses of cellular and humoral immune responses will be presented.
