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Bin-Chao Wang



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    JCSE01 - Perspectives for Lung Cancer Early Detection (ID 779)

    • Event: WCLC 2018
    • Type: Joint IASLC/CSCO/CAALC Session
    • Track: Screening and Early Detection
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/23/2018, 07:30 - 11:15, Room 202 BD
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      JCSE01.09 - Cluster Trial: Ph2 Biomarker-Integrated Study of Single Agent Alpelisib, Capmatinib, Ceritinib and Binimetinib in advNSCLC (Now Available) (ID 11678)

      10:15 - 10:25  |  Author(s): Bin-Chao Wang

      • Abstract
      • Presentation
      • Slides

      Background
      Several genetically altered signaling pathways have been profiled in NSCLC, enabling advanced management of NSCLC using targeted therapies. This study investigated the therapeutic spectrum of NSCLC with uncommon molecular alterations by allocating patients to treatment arms based on molecular aberrations; targeted therapies alpelisib (PI3Kαi), capmatinib (METi), ceritinib (ALKi), and binimetinib (MEKi) were evaluated.The study was based on the umbrella design. Key objectives: investigate feasibility of using one trial for different agents based on biomarker-integrated analysis, assess anti-tumor activity, characterize safety, tolerability and PK profiles of individual agents. Key eligibility criteria: age ≥18 years; ECOG PS ≤2; failed prior treatment/unsuitable for chemotherapy. Documentation of locally determined molecular alterations before treatment allocation was required (alpelisib, 350 mg QD: PIK3CA mutation/amplification; capmatinib, 400 mg BID (tablet): MET IHC overexpression/amplification; ceritinib, 750 mg QD: ALK or ROS1 rearrangement; binimetinib, 45 mg BID: KRAS, NRAS or BRAF mutation).Sixty-six patients with advNSCLC were enrolled (median age 58 years; 65.2% male: alpelisib, n=2; capmatinib, n=16; ceritinib, n=26; binimetinib, n=22). As of Feb 28, 2018, 10 patients in ceritinib and 2 in binimetinib arms were ongoing. Twenty-four patients had confirmed partial responses (36.4%): alpelisib, 0%; capmatinib, 18.8%; ceritinib, 73.1%; binimetinib, 9.1% (Figure). Longest mPFS (14.4 months) was in ceritinib arm. Among the most common treatment-related AEs: alpelisib: malaise, hyperglycemia, dysgeusia; capmatinib: nausea, anemia, peripheral edema, decreased appetite; ceritinib: diarrhea, vomiting, ALT/AST elevation; binimetinib: mouth ulceration, AST, blood CPK increased, rash. Most AEs were grade 1/2.

      abstract #1.jpg

      Objective responses/tumor shrinkage were observed in the study; highest ORR and mPFS were observed with ceritinib, although patient numbers differed between arms. All treatments were well tolerated; no new safety signals were observed. This study demonstrated the feasibility of an umbrella trial and importance of precision medicine in the management of advNSCLC with uncommon molecular alterations.

      a9ded1e5ce5d75814730bb4caaf49419

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-97 - Cluster Trial: Ph2 Biomarker-Integrated Study of Single Agent Alpelisib, Capmatinib, Ceritinib and Binimetinib in advNSCLC (ID 12065)

      16:45 - 18:00  |  Author(s): Bin-Chao Wang

      • Abstract
      • Slides

      Background

      Several genetically altered signaling pathways have been profiled in NSCLC, enabling advanced management of NSCLC using targeted therapies. This study investigated the therapeutic spectrum of NSCLC with uncommon molecular alterations by allocating patients to treatment arms based on molecular aberrations; targeted therapies alpelisib (PI3Kαi), capmatinib (METi), ceritinib (ALKi), and binimetinib (MEKi) were evaluated.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The study was based on the umbrella design. Key objectives: investigate feasibility of using one trial for different agents based on biomarker-integrated analysis, assess anti-tumor activity, characterize safety, tolerability and PK profiles of individual agents. Key eligibility criteria: age ≥18 years; ECOG PS ≤2; failed prior treatment/unsuitable for chemotherapy. Documentation of locally determined molecular alterations before treatment allocation was required (alpelisib, 350 mg QD: PIK3CA mutation/amplification; capmatinib, 400 mg BID (tablet): MET IHC overexpression/amplification; ceritinib, 750 mg QD: ALK or ROS1 rearrangement; binimetinib, 45 mg BID: KRAS, NRAS or BRAF mutation).

      4c3880bb027f159e801041b1021e88e8 Result

      Sixty-six patients with advNSCLC were enrolled (median age 58 years; 65.2% male: alpelisib, n=2; capmatinib, n=16; ceritinib, n=26; binimetinib, n=22). As of Feb 28, 2018, 10 patients in ceritinib and 2 in binimetinib arms were ongoing. Twenty-four patients had confirmed partial responses (36.4%): alpelisib, 0%; capmatinib, 18.8%; ceritinib, 73.1%; binimetinib, 9.1% (Figure). Longest mPFS (14.4 months) was in ceritinib arm. Among the most common treatment-related AEs: alpelisib: malaise, hyperglycemia, dysgeusia; capmatinib: nausea, anemia, peripheral edema, decreased appetite; ceritinib: diarrhea, vomiting, ALT/AST elevation; binimetinib: mouth ulceration, AST, blood CPK increased, rash. Most AEs were grade 1/2.

      wclc figure for abstract-1.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion


      Objective responses/tumor shrinkage were observed in the study; highest ORR and mPFS were observed with ceritinib, although patient numbers differed between arms. All treatments were well tolerated; no new safety signals were observed. This study demonstrated the feasibility of an umbrella trial and importance of precision medicine in the management of advNSCLC with uncommon molecular alterations.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-64 - Preliminary Data of Diverse Therapies in Patients with Advanced Non–Small-Cell Lung Cancer Harbouring RET-Rearrangement (ID 13677)

      12:00 - 13:30  |  Author(s): Bin-Chao Wang

      • Abstract
      • Slides

      Background

      Activating RET-rearrangement has been discovered to play a crucial role in NSCLC tumorigenesis. However, the lack of specificity narrowed efficacy of multi-kinase inhibitors (MKIs) and the optimal treatment remains unknown. In this study, we compared chemotherapy, immunotherapy and MKIs in this group of patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively evaluated the efficacy of these three treatments in advanced, RET-rearranged NSCLC patients between January 2013 and April 2018 at our institution. RET-rearrangements were assessed by Next-generation sequencing (NGS) or any of FISH, IHC, RT-PCR. Treatment data were collected after the patients had been diagnosed with RET-rearranged advanced NSCLC. Progression-free survival (PFS) was measured from treatment start to disease progression, all-cause mortality or last follow up. Median follow-up time was 5.1months. NGS was performed to assess somatic mutation of available samples.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 30 patients with RET-rearrangement were investigated in this study. After the diagnosis, 15 patients, genetic profiles confirmed by NGS, received chemotherapy (n=10), checkpoint-inhibitors (n=7) and RET targeted MKI (n=6) with evaluable response. Several patients take any two of these three treatments as different line therapies. The disease control rate of chemotherapy, immunotherapy, MKI group was 70.0%, 71.43% and 50%, respectively. While the median PFS of three groups was 2.50 months, 2.70 months, 0.30 months, respectively, which of no significance. The NGS data of 10 patients showed that RET-rearrangement co-occurred with several other genes, including TP53, NTRK, CDK4, ERBB4. A low mutation burden (mean 4.5 mutations) was observed (Figure 1).

      figure of abstract 13677.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      We confirmed relatively low PFS in advanced RET-rearranged NSCLC with MKIs reported in previous studies. But further investigation is warranted. Treatment with checkpoint-inhibitors seemed to encouragingly prolong PFS but a larger group of patients is needed to draw a definite conclusion.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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