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Christine Lee Hann

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    OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 8
    • Now Available
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      OA03.01 - A Non-Randomized, Open-Label, Prospective, Multicenter Study of Apatinib as Second-Line and Later-Line Therapy in Patients with ES-SCLC (Now Available) (ID 486)

      13:30 - 15:00  |  Presenting Author(s): Quan Liu  |  Author(s): Dong Hua, Junying Xu, Yehong Xu, Meng Chen, Lichun Deng, Jianping Wu, Tong Zhou, Liqin Zhang, Jie Tan, Xingxiang Pu, Yulong Shang, Jun Hua, Yuanqin Li, Wei Cai, Yulan Gu, Xingchen Peng

      • Abstract
      • Presentation
      • Slides

      Background

      Small-cell lung cancer (SCLC) accounts for approximately 10–15% of the total number of lung cancer cases. In extensive-stage (ES) SCLC, the 5-year survival rate is less than 5%, which was mainly caused by rapid recurrence and resistance to second-line chemotherapy despite the high response to first-line chemotherapy. This study evaluated the efficacy and safety of apatinib, an orally administered small-molecule targeted drug, in second-line and later-line therapy for patients with ES-SCLC (ChiCTR-OPC-17013964).

      Method

      From July 28, 2017 to March 24, 2019, 52 patients who failed in first-line and above chemotherapy treatment were enrolled and received apatinib 500 mg per day. The efficacy was evaluated after 4-weeks treatment (1 cycle), and then evaluated once every 2 cycles. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), overall response rate (ORR) and disease control rate (DCR). The adverse events were also recorded.

      Result

      Of 52 enrolled patients, 36 patients were available for efficacy analysis. The median PFS was 6.18 months (95%CI: 3.26-7.99) and the median OS did not achieve. The mPFS of patients received apatinib as second-line treatment was 6.48 months. Patients who received first-line chemotherapy more than 6 months had longer PFS and OS than patients received less than 6months. 31 patients were available for tumor response evaluation. The ORR and DCR were 19.35% and 83.87%, respectively. During the treatment, 96 adverse events were detected. Among them, 3-4 grade adverse reactions were hypertension (8.33%), hand-foot syndrome (5.56%), hypodynamia (5.56%) and proteinuria (2.78%), which all alleviated by reducing dose and symptomatic treatment.

      Table 1 Patient baseline characteristicstable 1 patient baseline characteristics.png

      Conclusion

      Apatinib was effective for SCLC patients who failed in first-line and above chemotherapy and the adverse events were tolerable.

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      OA03.02 - Effect of Anlotinib in Advanced Small Cell Lung Cancer Patients Previously Received Chemoradiotherapy: A Subgroup Analysis in ALTER 1202 Trial (Now Available) (ID 1698)

      13:30 - 15:00  |  Presenting Author(s): Qiming Wang  |  Author(s): Ying Cheng, Kai Li, Jianhua Shi, Baohui Han, Lin Wu, Gongyan Chen, Jianxing He, Jie Wang, Haifeng Qin, Xiao-Ling Li

      • Abstract
      • Presentation
      • Slides

      Background

      The ALTER 1202 trial showed significant improvement in progress-free survival and well tolerant with anlotinib in advanced small cell lung cancer (SCLC) patients received at least two lines chemotherapy. Here, we reported the effect of anlotinib in patients previously received chemoradiotherapy.

      Method

      The ALTER 1202 was a randomized, double-blind phase 2 trial conducted at 11 centers in China. Patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled and randomized in a 2:1 ratio to receive either anlotinib or placebo until tumor progression or unacceptable toxicity. The subgroup analysis assessed the effect of anlotinib in patients with previous concurrent, sequential and alternate chemoradiotherapy. The primary outcome was progressive-free survival (PFS). The secondary outcomes were overall survival (OS), objective response rate, disease control rate and safety. Data are reported as per the 30 June 2018, data cutoff date. This trial is registered with ClinicalTrials.gov, number NCT03059797.

      Result

      Between March 30, 2017 and June 8, 2018, a total of 120 patients who met all eligibility criteria were randomly assigned to the anlotinib group (82 patients) or placebo group (38 patients). And 46 patients in anlotinib group and 22 patients in placebo group previously received chemoradiotherapy. Among them, the median PFS was 5.49 months (95% confidence interval [CI], 2.83 to 6.47) with anlotinib versus 0.69 months (95% CI, 0.66 to 0.76) with placebo (hazard ratio [HR], 0.14; 95% CI, 0.07 to 0.28; P<0.0001). Meanwhile, anlotinib significantly prolonged OS compared with placebo (9.49 months [95% CI, 7.29 to 12.68] versus 2.56 months [95% CI, 0.49 to 5.22]; HR, 0.46 [95% CI, 0.22 to 0.98]; P=0.0388) in patients previously received chemoradiotherapy. The most common adverse events were hypertension (39.13%), weight loss (39.13%), hypertriglyceridemia (36.96%) and leukopenia (30.43%). While, the most common grade 3 or worse adverse events were hypertension (15.22%), hypertriglyceridemia (10.87%), γ-glutamyl-transferase increased (8.70%).

      Conclusion

      Anlotinib improved PFS and OS in advanced SCLC patients previously received chemoradiotherapy and was well tolerated.

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      OA03.03 - Initial Efficacy and Safety Results of Irinotecan Liposome Injection (nal-IRI) in Patients with Small Cell Lung Cancer (Now Available) (ID 1985)

      13:30 - 15:00  |  Presenting Author(s): Luis Paz-Ares  |  Author(s): David R Spigel, Yuanbin Chen, Maria Jove, Oscar Juan, Patricia Rich, Theresa Hayes, Vanesa Gutiérrez Calderón, Reyes Bernabe, Alejandro Navarro, Afshin Dowlati, Bin Zhang, Yan Moore, Tiffany Wang, Natalya Nazarenko, Santiago Ponce, Paul A Bunn, Jr

      • Abstract
      • Presentation
      • Slides

      Background

      SCLC accounts for ~15% of lung cancers, with 5-year survival <10%. 50-90% of patients with extensive disease respond to initial treatment; many rapidly relapse due to acquired resistance to front-line platinum-based chemotherapy. Limited treatment options are available for second-line patients. nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor), utilizing intraliposomal stabilization technology to enable high drug load and in-vivo stability.

      Method

      RESILIENT (NCT03088813) is a two-part Phase 2/3 study assessing the safety, tolerability, and efficacy of monotherapy nal-IRI in SCLC patients who progressed on/after a front-line platinum regimen: Part 1 includes dose-finding then dose-expansion. Key eligibility criteria included ECOG PS 0-1 and adequate organ function, with prior exposure to immunotherapy allowed. Eligible patients received nal-IRI 70mg/m2 or 85mg/m2 (free-base equivalent) q2w. Primary endpoints were safety and tolerability. Efficacy assessments included objective response rate (ORR), best overall response (BOR), progression-free survival (PFS), and overall survival (OS).

      Result

      30 patients were treated for >12 weeks in Part 1 (male, 43%; median age, 60.4y; platinum-resistant, 40%) with tumor assessments q6w. During dose-finding, 5 patients received nal-IRI 85mg/m2 (deemed not tolerable: dose-limiting toxicity) and 12 patients received nal-IRI 70mg/m2 (deemed tolerable: selected for dose expansion). At data cut-off** (median follow-up, 4.4mo), 25 patients had received nal-IRI 70mg/m2. Diarrhea was the most common gastrointestinal adverse events (AEs) (Gr3, 20%). Hematologic AEs included neutropenia (Gr3, 8%; Gr4, 8%), anemia (Gr3, 8%), febrile neutropenia (Gr3, 4%), thrombocytopenia (Gr3, 4%; Gr4, 4%). Preliminary efficacy identified 11 patients with partial responses (ORR 44%), BOR (PR+SD) of 72%, and 12-week disease control rate (DCR12wks PR+SD) of 48%. PFS and OS are not yet mature.

      Conclusion

      Part 1 demonstrated encouraging anti-tumor activity for nal-IRI 70mg/m2 in patients with SCLC (ORR: 44%, BOR: 72%). nal-IRI 70mg/m2 was generally well tolerated. Future research is warranted to assess nal-IRI in second-line SCLC.

      Table 1. Baseline Demographic, Patient Disposition, Safety & Tolerability, and Clinical Efficacy for Part 1 of the RESILIENT study

      Dose-Finding /
      Dose-Exploration Phase
      Irinotecan
      Liposome
      Injection
      85mg/m2
      (N=5)
      Irinotecan
      Liposome
      Injection
      70mg/m2
      (N=25)
      Baseline Characteristics
      Gender, Male, n (%) 3 (60.0) 10 (40.0)
      Age (Years, median) 62.0 59.0
      Baseline ECOG
      0 1 (20.0) 3 (12.0)
      1 4 (80.0) 22 (88.0)
      Time Since Most Recent Progression (Weeks, median) 3.4 3.2
      Disease Location, n (%)
      Locally Advanced 0 2 (8.0)
      Metastatic 5 (100.0) 23 (92.0)
      Disposition, n (%)
      Patient Completed Study 4 (80.0) 12 (48.0)
      Patient Currently Ongoing* 7 (28.0)
      Deaths 2 (40.0) 6 (24.0)
      Disease Related 1 3
      Adverse Event Not Related to Study Drug 1 1
      Cardiac Arrest 1 -
      Hepatic Failure - 1
      Adverse Event Related to Study Drug 0 2
      Abdominal Sepsis - 2
      Patient Discontinued Treatment 5 (100.0) 18 (72.0)
      Safety & Tolerability, n (%)
      Any Treatment-Emergent Adverse Event (TEAE) 5 (100.0) 25 (100.0)
      Grade 3 or Higher TEAE (≥ 2 patients) 5 (100.0) 15 (60.0)
      Neutropenia 1 (20.0) 4 (16.0)
      Anemia 2 (8.0)
      Thrombocytopenia 2 (8.0)
      Diarrhea 3 (60.0) 5 (20.0)
      Asthenia 2 (8.0)
      General Physical Health Deterioration 2 (8.0)
      Pneumonia 2 (40.0) 1 (4.0)
      Abdominal Sepsis 2 (8.0)
      Hypokalemia 1 (20.0) 2 (8.0)
      Renal Failure 2 (8.0)
      Best Overall Response
      Complete Response (CR)
      Partial Response (PR) 2 (40.0) 11 (44.0)
      Stable Disease 1 (20.0) 7 (28.0)
      Progressive Disease 1 (20.0) 5 (20.0)
      Non-evaluable 1 (20.0) 2 (8.0)
      Objective Response Rate
      CR + PR 2 (40.0) 11 (44.0)
      Non-responder 3 (60.0) 14 (56.0)
      ** Data Cut-off: May 8, 2019.
      * Per RECIST v1.1 or RANO criteria.

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      OA03.04 - Discussant - OA03.01, OA03.02, OA03.03 (Now Available) (ID 3728)

      13:30 - 15:00  |  Presenting Author(s): Flavia Amaral Duarte

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      OA03.05 - Characterization of Genomic Alterations in Chinese LCNEC and SCLC via Comprehensive Genomic Profiling (Now Available) (ID 1486)

      13:30 - 15:00  |  Presenting Author(s): Lin Wu  |  Author(s): Liming Cao, Likun Chen, Bo Zhu, Xiaohua Hu, Gen Lin, Yingcheng Lin, Sheng Zhang, Wenying Peng, Meilin Jiang, Xinru Mao, Tengfei Zhang, Junyi Ye, Lu Zhang

      • Abstract
      • Presentation
      • Slides

      Background

      LCNEC and SCLC are aggressive neuroendocrine carcinomas with overlap in clinical, histopathologic, morphologic and genomic features. Differential molecular features between the two subtypes have not been well elucidated, contributing the uncertainty for optimal clinical strategy for each subtype. Here we interrogated the genomic characteristics in LCNEC as compared to SCLC along with their histologically related subtypes: carcinoids and atypical carcinoids via comprehensive genomic profiling.

      Method

      FFPE samples from 31 LCNECs, 35 SCLCs, 14 carcinoids and 22 atypical carcinoids were sequenced in a CLIA-certified sequencing laboratory using 520-cancer-related gene panel, with an average sequencing depth of 1385X.

      Result

      Comparative mutational analysis revealed that both LCNEC and SCLC sub-cohorts displayed higher rate of TP53 alterations than that of carcinoid (p<0.001, p<0.001). SCLC patients harbored more RB1 and PIK3CA mutations than LCNECs (p<0.001, p=0.014) and carcinoids (p<0.001, p=0.018). In addition, mutation frequencies of LRP1B, FAT1, PRKDC, PIK3CA, NOTCH1, SPTA1 and EPHA3 in SCLC were significantly higher than that in carcinoid. Mutations in TP53 and RB1 occurred concurrently in 83% (29/35) SCLC patients, whereas in only 32.3% (10/31) LCNECs.(Fig.1) We further investigated the distribution of mutations across KEGG pathways and found that mutation frequencies in both HIF-1 and Notch signaling pathways were lower in LCNEC than SCLC (p=0.032, p=0.025). Copy number variation (CNV) analysis revealed that LCNEC and SCLC had comparable CNVs which were significantly higher than carcinoid (p<0.001, p<0.001) and atypical carcinoid (p=0.010, p=0.028). TMB analysis also revealed a comparable TMB status of LCNEC (12.7/Mb) and SCLC (11.9/Mb), and relatively lower TMB in both carcinoid (2.4/Mb, p<0.001, p<0.001) and atypical carcinoid (5.6/Mb, p=0.003, p=0.009) than LCNEC and SCLC.

      wclc lcnec figure 1.jpg

      Conclusion

      We demonstrated the differential genomic characteristics in the four subtypes of neuroendocrine carcinomas. Compared with SCLC, LCNEC has lower mutation frequencies in RB1, PIK3CA, as well as HIF-1 and Notch signaling pathways. In addition, LCNEC and SCLC had comparable CNV and TMB status, which significantly higher than that of carcinoids and atypical carcinoid.

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      OA03.06 - ASCL1, NEUROD1, and POU2F3 Drive Distinct Subtypes of Small Cell Lung Cancer with Unique Therapeutic Vulnerabilities (Now Available) (ID 1433)

      13:30 - 15:00  |  Presenting Author(s): Carl M. Gay  |  Author(s): Lixia Diao, C. Allison Stewart, Yuanxin Xi, Robert J. Cardnell, Stephen Swisher, Jack Roth, Bonnie Glisson, Jing Wang, John Victor Heymach, Lauren Averett Byers

      • Abstract
      • Presentation
      • Slides

      Background

      Background: Accounting for 15% of all lung cancer diagnoses, small cell lung cancer (SCLC) is an aggressive malignancy with dismal clinical outcomes, due in part to failure to define clinical biomarkers predictive of unique, targetable vulnerabilities. Recent data has begun to delineate molecular subsets of SCLC by uncovering inter-tumoral heterogeneity in features such as DNA damage response, EMT, and neuroendocrine (NE) status. However, it remains unclear whether the subsets defined by these features are predictive of response to cancer therapies and could be employed as patient selection criteria.

      Method

      Methods: Using RNAseq data from 81 resected SCLC tumor samples and 62 SCLC cell lines, we applied non-negative matrix factorization (NMF) to optimize delineation of transcriptionally defined clusters. Reverse phase protein array (RPPA) and drug response data for cell lines were analyzed post-clustering to compare features between clusters. Clustering analyses were validated in vivo using CTC-derived patient xenograft (CDX) models, while single-cell RNAseq (scRNAseq) from these same models was used to assess intratumoral heterogeneity among clusters.

      Result

      Results: NMF identifies four biologically distinct clusters among SCLC tumor samples and cell lines, each defined almost solely by differential expression of the transcription factors ASCL1 (SCLC-A, 36%), NEUROD1 (SCLC-N, 31%), and POU2F3 (SCLC-P, 16%), including a cluster defined by the absence of all three (SCLC-Inflamed/Mesenchymal, or SCLC-IM, 17%). SCLC-A are neuroendocrine, epithelial tumors with susceptibility to drug classes including BCL-2 inhibitors. SCLC-N are neuroendocrine, cMYC-high tumors with susceptibilities including Aurora kinase inhibitors that are neither epithelial nor mesenchymal. SCLC-P are non-neuroendocrine, epithelial tumors vulnerable to PARP inhibitors and nucleoside analogs. Lastly, SCLC-IM consists of mesenchymal, non-neuroendocrine tumors with high-expression of immune checkpoints, STING-related genes, and inflammatory markers that may represent those SCLC which are sensitive to immune checkpoint blockade. scRNAseq reveals intratumoral heterogeneity among cluster assignment within tumors that fluctuates coincident with the onset of therapeutic resistance.

      Conclusion

      Conclusions: SCLC tumors can be assigned to one of four molecular subtypes on the basis of differential expression of three transcription factors. These subtype assignments reflect profound distinctions in underlying biology and susceptibility to a range of candidate drug classes. While subtype assignment on a single-cell basis within a tumor is largely homogeneous, rare cells from distinct subtypes (or representing multiple subtypes), as well as shifting assignments following treatment indicate the possibility of subtype-switching, or subtype-selection, as mechanisms of therapeutic resistance.

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      OA03.07 - Immune-Related Adverse Events and Clinical Outcome to Anti PD-1 Axis Inhibition in SCLC: A Multicenter Retrospective Analysis (Now Available) (ID 2880)

      13:30 - 15:00  |  Presenting Author(s): Biagio Ricciuti  |  Author(s): abdul rafeh Naqash, Brian Henick, Deepa Rangachari, Jarushka Naidoo, Deepti Venkatraman, Giuseppe Lamberti, Gonzalo Recondo Jr., Jiajia Zhang, Shravanti Macherla, Sameer Baig, Paul Raymond Walker, Kartik Sehgal, Renato Umeton, Lynette M Sholl, Naiyer A Rizvi, Daniel B Costa, Mark Awad

      • Abstract
      • Presentation
      • Slides

      Background

      Immune-checkpoint inhibitors (ICIs) have shown promising activity in only a fraction of patients with small cell lung cancer (SCLC), and factors associated with clinical benefit are not well characterized. The development of immune-related adverse events (irAEs) may correlate with benefit from immune checkpoint inhibitors (ICIs) among patients with cancer. Whether an association exists between irAE development and improved clinical outcomes to ICIs in small cell lung cancer (SCLC) is unknown.

      Method

      We retrospectively analyzed data from five participating academic centers: the Dana-Farber Cancer Institute, East Carolina University, Columbia University, Beth Israel Deaconess Medical Center, and Johns Hopkins University. Patients with SCLC who received at least one dose of a programmed death (ligand) PD-(L)1 inhibitor alone or in combination with a cytotoxic T-lymphocyte associated protein 4 (CTLA-4) inhibitor were included in this study. To account for the time-dependent nature of irAE onset and clinical benefit from immunotherapy, we identified patients with early irAEs (defined as those occurring within 6 weeks of ICI treatment initiation) and performed a landmark analysis at this time point.

      Result

      Among 157 patients treated with ICIs, 65 (41.4%) experienced at least one irAE. Median time to the first irAE onset was 28 days (IQR:15-56). Baseline clinicopathologic characteristics were well balanced between patients who developed irAEs and those who did not. Median tumor mutational burden (TMB) was significantly higher among patients with irAEs compared to those without (14.4 vs 8.4 mutations/megabase [mut/Mb], P <0.01). Patients who developed at least one irAE had a significantly higher objective response rate (26.3% versus 3.3%, P <0.001), and significantly longer median progression-free survival (mPFS, 4.1 vs 1.3 months, HR: 0.30 [0.20-0.43, P <0.001]) and median overall survival (mOS, 14.1 vs 2.9 months, HR: 0.32 [0.21-0.48], P <0.001). The proportion of patients who were progression-free at 6, 9, and 12 weeks was significantly higher in patients who developed early irAEs compared to those who did not develop early irAEs (6 weeks: 89.5% vs 69.5%, P =0.01; 9 weeks: 71.1% vs 40%, P =0.001; 12 weeks: 65.8% vs. 31.6%, P <0.001). The median TMB was also significantly higher in patients who developed early irAEs (14.5 vs 8.7 mut/Mb, P <0.01).

      Conclusion

      Patients with SCLC treated with ICIs who developed early irAEs had a higher TMB and enhanced antitumor responses compared to those who did not develop irAEs. Whether a higher TMB is associated with the development of irAEs remains to be determined mechanistically.

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      OA03.08 - Discussant - OA03.05, OA03.06, OA03.07 (Now Available) (ID 3729)

      13:30 - 15:00  |  Presenting Author(s): Herbert H. Loong

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    MS14 - Molecular Subsets and Novel Targeted Approaches to Small Cell and Neuroendocrine Cancers (ID 77)

    • Event: WCLC 2019
    • Type: Mini Symposium
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
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      MS14.01 - Molecular Subsets of Neuroendocrine Tumors (Now Available) (ID 3519)

      11:30 - 13:00  |  Presenting Author(s): Christine Lee Hann

      • Abstract
      • Presentation
      • Slides

      Abstract

      Small cell lung cancer (SCLC) is an aggressive tumor with one of the highest case-fatality rates among cancer. Clinically SCLC is hallmarked by early metastatic behavior and rapid development of therapeutic resistance. Over the past decades multiple research teams have used genomic, epigenomic, transcriptomic and proteomic approaches to further characterize SCLC. Long considered a relatively homogeneous tumor, these data have led to a deeper understanding of SCLC biology and support the concept that there are distinct biologic subsets of SCLC. Complementary work using patient-derived xenografts and genetically engineered mouse models have validated some of this data and these models serve as platforms for novel therapeutic development. These studies support translational efforts in SCLC focused on distinct vulnerabilities in subsets of this disease and the development of predictive biomarkers.

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