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Andres Forerotorres - One of the best experts on this subject based on the ideXlab platform.

  • tbcrc 019 a phase ii trial of nanoparticle albumin bound paclitaxel with or without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Nan Lin, Minetta C Liu, Anna Maria Storniolo
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5 + human tumor cells without crosslinking. TIG has strong in vitro / in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4–5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation. Clin Cancer Res; 21(12); 2722–9. ©2015 AACR . See related article by Paoletti et al., p. 2771

  • tbcrc 019 phase ii trial of nab pac with without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Anna M Stroniolo, Tiffany A Traina, Sujata Patil
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5+ human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) + TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly x 3 + TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n=39 and nab-PAC n=21), there were 3 complete remissions (CRs), 8 partial remissions (PRs; 1 almost CR), 11 stable diseases (SDs) and 17 progressive diseases (PDs) in the TIG/nab-PAC arm (ORR=28%), and no CRs, 8 PRs, 4 SDs and 9 PDs in nab-PAC arm (ORR=38%). There was a numerical increase in CRs and several patients had prolonged PFS (1025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29% respectively with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR-5 agents. ROCK pathway activation merits further evaluation.

Sujata Patil - One of the best experts on this subject based on the ideXlab platform.

  • tbcrc 019 phase ii trial of nab pac with without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Anna M Stroniolo, Tiffany A Traina, Sujata Patil
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5+ human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) + TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly x 3 + TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n=39 and nab-PAC n=21), there were 3 complete remissions (CRs), 8 partial remissions (PRs; 1 almost CR), 11 stable diseases (SDs) and 17 progressive diseases (PDs) in the TIG/nab-PAC arm (ORR=28%), and no CRs, 8 PRs, 4 SDs and 9 PDs in nab-PAC arm (ORR=38%). There was a numerical increase in CRs and several patients had prolonged PFS (1025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29% respectively with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR-5 agents. ROCK pathway activation merits further evaluation.

Anna Maria Storniolo - One of the best experts on this subject based on the ideXlab platform.

  • tbcrc 019 a phase ii trial of nanoparticle albumin bound paclitaxel with or without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Nan Lin, Minetta C Liu, Anna Maria Storniolo
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5 + human tumor cells without crosslinking. TIG has strong in vitro / in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4–5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation. Clin Cancer Res; 21(12); 2722–9. ©2015 AACR . See related article by Paoletti et al., p. 2771

Rita Nanda - One of the best experts on this subject based on the ideXlab platform.

  • tbcrc 019 a phase ii trial of nanoparticle albumin bound paclitaxel with or without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Nan Lin, Minetta C Liu, Anna Maria Storniolo
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5 + human tumor cells without crosslinking. TIG has strong in vitro / in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4–5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation. Clin Cancer Res; 21(12); 2722–9. ©2015 AACR . See related article by Paoletti et al., p. 2771

  • tbcrc 019 phase ii trial of nab pac with without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Anna M Stroniolo, Tiffany A Traina, Sujata Patil
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5+ human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) + TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly x 3 + TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n=39 and nab-PAC n=21), there were 3 complete remissions (CRs), 8 partial remissions (PRs; 1 almost CR), 11 stable diseases (SDs) and 17 progressive diseases (PDs) in the TIG/nab-PAC arm (ORR=28%), and no CRs, 8 PRs, 4 SDs and 9 PDs in nab-PAC arm (ORR=38%). There was a numerical increase in CRs and several patients had prolonged PFS (1025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29% respectively with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR-5 agents. ROCK pathway activation merits further evaluation.

Katherine E Varley - One of the best experts on this subject based on the ideXlab platform.

  • tbcrc 019 a phase ii trial of nanoparticle albumin bound paclitaxel with or without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Nan Lin, Minetta C Liu, Anna Maria Storniolo
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5 + human tumor cells without crosslinking. TIG has strong in vitro / in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4–5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation. Clin Cancer Res; 21(12); 2722–9. ©2015 AACR . See related article by Paoletti et al., p. 2771

  • tbcrc 019 phase ii trial of nab pac with without the anti death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer
    Clinical Cancer Research, 2015
    Co-Authors: Andres Forerotorres, Katherine E Varley, Vandana G Abramson, Yufeng Li, Christos Vaklavas, Hope S Rugo, Rita Nanda, Anna M Stroniolo, Tiffany A Traina, Sujata Patil
    Abstract:

    Purpose: Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5+ human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Experimental Design: Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) + TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly x 3 + TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Results: Among 64 patients (60 treated; TIG/nab-PAC n=39 and nab-PAC n=21), there were 3 complete remissions (CRs), 8 partial remissions (PRs; 1 almost CR), 11 stable diseases (SDs) and 17 progressive diseases (PDs) in the TIG/nab-PAC arm (ORR=28%), and no CRs, 8 PRs, 4 SDs and 9 PDs in nab-PAC arm (ORR=38%). There was a numerical increase in CRs and several patients had prolonged PFS (1025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29% respectively with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. Conclusions: ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR-5 agents. ROCK pathway activation merits further evaluation.

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