Virtual Library

Start Your Search

Charles M. Rudin



Author of

  • +

    ES26 - Future Horizons in the Management of Small Cell Lung Cancer (ID 225)

    • Event: WCLC 2020
    • Type: Educational Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • +

      ES26.02 - Antibody Drug Conjugates and T-cell Engagers (ID 4064)

      14:15 - 15:15  |  Presenting Author(s): Charles M. Rudin

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    FP03 - Immuno-biology and Novel Immunotherapeutics (Phase I and Translational) (ID 151)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
    • +

      FP03.03 - Clinical Activity of BMS-986012, an Anti–Fucosyl-GM1 Monoclonal Antibody, Plus Nivolumab in Small Cell Lung Cancer (ID 3396)

      00:00 - 00:00  |  Author(s): Charles M. Rudin

      • Abstract
      • Slides

      Introduction

      In patients with extensive-stage small cell lung cancer (ES-SCLC), the addition of an anti–PD-L1 regimen to chemotherapy demonstrated limited benefit, with an increase in survival by 2 months (Horn et al. N Engl J Med. 2018;379:2220–2229). Therefore, future prospects for better outcomes in SCLC lie in novel medicines and new treatment combinations. Fucosyl-GM1 is a monosialoganglioside expressed in 50%–70% of SCLC with limited expression in normal tissues (Brezicka et al. APMIS. 1991;99:797–802; Brezicka et al. Tumour Biol. 1992;13:308–315). BMS-986012 is a nonfucosylated, fully human monoclonal antibody with high binding specificity for fucosyl-GM1 engineered to enhance antibody-dependent, cell-mediated cytotoxicity (Ponath et al. Clin Cancer Res. 2018;24:5178–5189). We previously reported that the combination of BMS-986012 and nivolumab in patients with relapsed/refractory SCLC was well tolerated and demonstrated preliminary antitumor activity (Chu et al. Ann Oncol. 2017;28(suppl 5). Abstract 1528PD). Here, we report updated safety and antitumor activity results from the phase 1/2 trial of the combination of BMS-986012 and nivolumab in patients with relapsed/refractory SCLC (NCT02247349).

      Methods

      Patients with relapsed/refractory SCLC who had not received prior checkpoint inhibitor (CPI) therapy received BMS-986012 400 or 1000 mg with nivolumab 360 mg intravenously every 3 weeks. The primary endpoint was safety. Secondary endpoints included investigator-assessed objective response rate (ORR), median duration of response (mDOR), median progression-free survival (mPFS), and pharmacokinetics. Median overall survival (mOS) was an exploratory endpoint.

      Results

      As of July 22, 2020, 29 patients received BMS-986012 (400 mg, n=21; 1000 mg, n=8) with nivolumab, with a follow-up of 18.6 months (range, 0.6–41.1 months). Median age of patients was 65 years (range, 46–79 years) and 52% were male; ECOG performance status was 0 (38%) or 1 (62%). The combination was well tolerated, with manageable adverse effects. The most common all-grade/grade ≥3 treatment-related adverse events were pruritus (93%/21%), fatigue (28%/0%), dry skin (28%/0%), and hypothyroidism (17%/0%). In most patients, pruritus diminished over time and was managed with antihistamines and low-dose corticosteroids. Confirmed ORR with BMS-986012 plus nivolumab was 38% (CR, n=1 [3%]; PR, n=10 [35%]), with 3 additional patients (10%) having SD, for an overall disease control rate of 48%. At data cutoff, mDOR was 26.4 months (95% CI, 4.4 months–NR); 4 patients were still on therapy. mPFS was 2.1 months (95% CI, 1.4–9.9 months) and mOS was 18.7 months (95% CI, 8.2 months–NR). No differences in response were noted between platinum-sensitive and refractory populations.

      Conclusion

      The results presented here suggest that BMS-986012 plus nivolumab is a promising therapeutic combination for the treatment of patients with relapsed/refractory SCLC not previously treated with CPI therapy, irrespective of whether their cancers were platinum sensitive or refractory. The safety profile was manageable, and although based on a small number of patients, responses were clinically meaningful and durable. These updated data warrant further investigation of this combination in patients with SCLC.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    IS02 - Industry Symposium Sponsored by AstraZeneca: Evolving the Role of Immunotherapy in Lung Cancer: ES-SCLC and Unresectable Stage III NSCLC (ID 278)

    • Event: WCLC 2020
    • Type: Industry Symposium
    • Track:
    • Presentations: 1
    • +

      IS02.05 - Emerging Biomarkers in SCLC (ID 4313)

      10:30 - 11:30  |  Presenting Author(s): Charles M. Rudin

      • Abstract

      Abstract not provided

  • +

    P47 - Small Cell Lung Cancer/NET - Biology / Translational (ID 234)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
    • +

      P47.06 - Delta-Radiomics Features for Assessment of Individualized Therapeutic Response in Small Cell Lung Cancer – A Pilot Study (ID 3340)

      00:00 - 00:00  |  Author(s): Charles M. Rudin

      • Abstract
      • Slides

      Introduction

      The difficulty of assessment of treatment response by current RECIST (Response Evaluation Criteria in Solid Tumors) criteria, limited by interobserver agreement and tumoral heterogeneity, may hinder personalized-medicine strategies in small cell lung cancer (SCLC). Our purpose is to evaluate computed tomography (CT) radiomic features before and after platinum-based chemotherapy in SCLC patients and to investigate how therapy-induced changes in these features, called delta-radiomics (DR) features, are related to treatment response as assessed by RECIST v 1.1.

      Methods

      18 patients with limited (2/18) or extensive (16/18) stage SCLC were retrospectively enrolled and CT scans immediately before and after platinum-based chemotherapy were analyzed. Patients were dichotomized into a group of responders [R] (partial response) and nonresponders [NR] groups (meaning stable or progressive disease) according RECIST v 1.1 criteria. Six patients were excluded for lack of standardization (acquisition protocol, intravenous contrast or image quality) between scans. Tumors were manually segmented (ITK SNAP v 3.8) and 101 radiomics features were extracted from both pre- and post-treatment images. A delta-radiomics signature was constructed using LASSO regression, a support vector machine and 5-fold cross-validation algorithms. ROC analysis to evaluate diagnostic accuracy for R vs NR differentiation was performed with a DeLong confidence interval for Area Under Curve (AUC).

      Results

      The delta-radiomics signature showed higher AUC than single-CT based radiomics signatures. Significant differences were noted for 12 radiomics features, between R and NR groups (P < 0.05). After LASSO regression 3 parameters were advanced to modelling. The accuracy of the final delta-radiomics model was 92%, sensitivity 86%, specificity 100.0%, positive predictive value 100%, negative predictive value 83.3% and area under ROC curve of 0.89.

      Conclusion

      Preliminary results showed a potential role of a delta-radiomics CT model in the individualized assessment of platinum-based chemotherapy response in SCLC. Larger sample studies are required to validate the reliability and reproducibility of our proposed radiomics model.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.