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823 results on '"Kopetz, S"'

52. P-45 An open-label, phase 2 study of patritumab deruxtecan in patients with previously treated advanced/metastatic colorectal cancer

Author

Raghav, K., primary, Yoshino, T., additional, Taniguchi, H., additional, Tejpar, S., additional, Vogel, A., additional, Wainberg, Z., additional, Yamaguchi, K., additional, Fakih, M., additional, Pedersen, K., additional, Bando, K., additional, Kawakami, H., additional, Beck, J., additional, Kanai, M., additional, Liu, Y., additional, Mekan, S., additional, Pudussery, G., additional, Qiu, Y., additional, and Kopetz, S., additional

Published
2021
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53. SO-28 Effect of prior bevacizumab treatment in BRAF V600E-mutant metastatic colorectal cancer: Overall survival with encorafenib + cetuximab +/- binimetinib in BEACON CRC

Author

Aderka, D., primary, Kopetz, S., additional, Grothey, A., additional, Van Cutsem, E., additional, Yaeger, R., additional, Wasan, H., additional, Yoshino, T., additional, Desai, J., additional, Ciardiello, F., additional, Golden, A., additional, Edwards, M., additional, and Tabernero, J., additional

Published
2021
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54. SO-27 Nivolumab plus low-dose ipilimumab in previously treated patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: 4-year follow-up from CheckMate 142

Author

André, T., primary, Lonardi, S., additional, Wong, K., additional, Lenz, H., additional, Gelsomino, F., additional, Aglietta, M., additional, Morse, M., additional, Van Cutsem, E., additional, McDermott, R., additional, Hill, A., additional, Sawyer, M., additional, Hendlisz, A., additional, Neyns, B., additional, Abdullaev, S., additional, Memaj, A., additional, Lei, M., additional, Kopetz, S., additional, and Overman, M., additional

Published
2021
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56. Encorafenib plus cetuximab with or without binimetinib for BRAF V600E metastatic colorectal cancer: Updated survival results from a randomized, three-arm, phase III study versus choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

Author

Maharry K., Murphy F., Gollerkeri A., Christy-Bittel J., Tabernero J., Price T., Kopetz S., Grothey A., Van Cutsem E., Yaeger R., Wasan H.S., Yoshino T., Desai J., Ciardiello F., Loupakis F., S Hong Y., Steeghs N., Guren T.K., Arkenau H.-T., Garcia-Alfonso P., Chantrill L., Tebbutt N., Strickland A., Karapetis C., Maharry K., Murphy F., Gollerkeri A., Christy-Bittel J., Tabernero J., Price T., Kopetz S., Grothey A., Van Cutsem E., Yaeger R., Wasan H.S., Yoshino T., Desai J., Ciardiello F., Loupakis F., S Hong Y., Steeghs N., Guren T.K., Arkenau H.-T., Garcia-Alfonso P., Chantrill L., Tebbutt N., Strickland A., and Karapetis C.

Abstract

Background: BEACONCRC is a randomized, phase 3 study which evaluated the triplet of encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) and the doublet of ENCO + CETUX vs. investigator's choice of irinotecan + CETUX or FOLFIRI + CETUX in patients (pts) with BRAFV600E metastatic colorectal cancer (mCRC) whose disease had progressed after 1-2 prior regimens in the metastatic setting. Primary endpoints were overall survival (OS) and objective response rate (ORR; by blinded central review) for triplet vs control. In a previous interim analysis, triplet and doublet improvedOS andORRversus standard of care. Here we report on an updated analysis. Method(s): Updated analysis includes 6 months of additional follow-up and response data for all randomized pts. The study is ongoing. Result(s): Patients received triplet (n = 224), doublet (n = 220), or control (n = 221). Median OS was 9.3 months (95% confidence interval [CI]:8.2, 10.8) for triplet and 5.9 months (95% CI:5.1-7.1) for control (hazard ratio [HR] (95% CI): 0.60 (0.47-0.75)). Median OS for doublet was 9.3 months (95% CI: 8.0-11.3) (HR vs control: 0.61 (0.48- 0.77). Confirmed ORR was 26.8% (95% CI: 21.1%-33.1%) for triplet, 19.5% (95% CI: 14.5%-25.4%) for doublet, and 1.8% (95% CI: 0.5%- 4.6%) for control. Retrospective subgroup analyses suggested some pts may benefit more from triplet than doublet therapy (Table). Both triplet and doublet showedimprovedOS compared to control in all subgroups. Adverse events were consistent with prior analysis, with grade >=3 adverse events in 65.8%, 57.4%, and 64.2% for triplet, doublet and control, respectively. Conclusion(s): The updated analysis of the BEACON CRC study confirmed that encorafenib + cetuximab with or without binimetinib improved OS and ORR in previously treated pts with BRAF V600E mCRC compared with standard chemotherapy.

Published
2021

57. BEACON CRC: A randomized, 3-Arm, phase 3 study of Encorafenib (ENCO) and Cetuximab (CETUX)with or without Binimetinib (BINI) versus choice of either Irinotecan or FOLFIRI plus Cetuximab in BRAF V600E-mutant metastatic colorectal cancer.

Author

Sandor V., Alfonso P.G., Price T., Strickland A., Tebbutt N., Karapetis C., Murphy F., Christy-Bittel J., Tabernero J., Anderson L., Desai J., Kopetz S., Grothey A., Van Cutsem E., Yaeger R., Wasan H., Yoshino T., Ciardello F., Gollerkeri A., Maharry K., Loupakis F., Hong Y.S., Steeghs N., Guren T.K., Arkenau H.-T., Chantrill L., Sandor V., Alfonso P.G., Price T., Strickland A., Tebbutt N., Karapetis C., Murphy F., Christy-Bittel J., Tabernero J., Anderson L., Desai J., Kopetz S., Grothey A., Van Cutsem E., Yaeger R., Wasan H., Yoshino T., Ciardello F., Gollerkeri A., Maharry K., Loupakis F., Hong Y.S., Steeghs N., Guren T.K., Arkenau H.-T., and Chantrill L.

Abstract

BRAF V600E mutations are identified in <=15% of metastatic colorectal cancer (mCRC) patients and confer a poor prognosis. In patient's refractory to initial therapy, ORR to standard chemotherapy and biologic combinations are generally <10%, with median PFS and OS of ~2 and 4-6 months, respectively. The BEACON CRC Study (NCT02928224) was a multicentre, randomized, open-label, 3-arm, phase 3 study evaluating ENCO + CETUX +/- BINI (triplet or doublet combination) versus investigator's choice of Irinotecan or FOLFIRI + CETUX (control) in patients with BRAF V600E-mutant mCRC who had failed one or two prior regimens in the metastatic setting. Primary endpoints were OS and ORR (blinded central review) for the triplet versus control arm; secondary endpoints included OS for the doublet versus control arm, as well as PFS, duration of response and safety. A total of 665 patients were randomly assigned to receive: triplet combination (n= 224), doublet combination (n= 220) or control regimen (n= 221). Median OS was 9.0 months (95% CI, 8.0-11.4) for the triplet versus 5.4 months (95% CI, 4.8-6.6) for control regimens (HR: 0.52; 95% CI, 0.39-0.70; P < .0001). ConfirmedORR(blinded central review) was 26% (95% CI, 18-35%) for the triplet versus 2% (95% CI, <1% to 7%) for control (P < .0001). Median OS for the doublet was 8.4months (95% CI, 7.5-11.0) (HR vs control, 0.60; 95% CI, 0.45-0.79; P = .0003). Adverse events (AEs) were consistent with prior trials with each combination. AEs >=grade 3 occurred in 58%, 50% and 61% of patients in the triplet, doublet and control arms, respectively. ENCO + BINI + CETUX improved OS and ORR in patients with BRAF V600E-mutant mCRC compared with current standard of care chemotherapy and had a safety profile consistent with the known safety profile of each agent. This targeted therapy regimen should be a new standard of care for this patient population.

Published
2021

58. Management of adverse events from the treatment of encorafenib plus cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer: insights from the BEACON CRC study

Author

Tabernero, J, Velez, L, Trevino, TL, Grothey, A, Yaeger, R, Van Cutsem, E, Wasan, H, Desai, J, Ciardiello, F, Yoshino, T, Gollerkeri, A, Maharry, K, Christy-Bittel, J, Kopetz, S, Tabernero, J, Velez, L, Trevino, TL, Grothey, A, Yaeger, R, Van Cutsem, E, Wasan, H, Desai, J, Ciardiello, F, Yoshino, T, Gollerkeri, A, Maharry, K, Christy-Bittel, J, and Kopetz, S

Abstract

Colorectal cancer is the second leading cause of cancer deaths worldwide, with a 5-year relative survival of 14% in patients with metastatic colorectal cancer (mCRC). Patients with BRAF V600E mutations, which occur in ∼10%-15% of patients with mCRC, have a poorer prognosis compared with those with wild-type BRAF tumours. The combination of the BRAF inhibitor encorafenib with the epidermal growth factor receptor inhibitor cetuximab currently represents the only chemotherapy-free targeted therapy approved in the USA and Europe for previously treated patients with BRAF V600E-mutated mCRC. As a class, BRAF inhibitors are associated with dermatologic, gastrointestinal, and renal events, as well as pyrexia and secondary skin malignancies. Adverse event (AE) profiles of specific BRAF inhibitors vary, however, and are affected by the specific agents given in combination. In patients with mCRC, commonly reported AEs of cetuximab monotherapy include infusion reactions and dermatologic toxicities. Data from the phase III BEACON CRC study indicate that the combination of encorafenib with cetuximab has a distinct safety profile. Here we review the most frequently reported AEs that occurred with this combination in BEACON CRC and best practices for managing and mitigating AEs that require more than standard supportive care.

Published
2021

59. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study

Author

Tabernero, J, Grothey, A, Van Cutsem, E, Yaeger, R, Wasan, H, Yoshino, T, Desai, J, Ciardiello, F, Loupakis, F, Hong, YS, Steeghs, N, Guren, TK, Arkenau, H-T, Garcia-Alfonso, P, Elez, E, Gollerkeri, A, Maharry, K, Christy-Bittel, J, Kopetz, S, Tabernero, J, Grothey, A, Van Cutsem, E, Yaeger, R, Wasan, H, Yoshino, T, Desai, J, Ciardiello, F, Loupakis, F, Hong, YS, Steeghs, N, Guren, TK, Arkenau, H-T, Garcia-Alfonso, P, Elez, E, Gollerkeri, A, Maharry, K, Christy-Bittel, J, and Kopetz, S

Abstract

PURPOSE: BEACON CRC evaluated encorafenib plus cetuximab with or without binimetinib versus investigators' choice of irinotecan or FOLFIRI plus cetuximab in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after progression on 1-2 prior regimens. In the previously reported primary analysis, encorafenib, binimetinib plus cetuximab (ENCO/BINI/CETUX; triplet) and encorafenib plus cetuximab (ENCO/CETUX; doublet) regimens improved overall survival (OS) and objective response rate (ORR; by blinded central review) versus standard of care. The purpose of this analysis was to report updated efficacy and safety data. METHODS: In this open-label, phase III trial, 665 patients with BRAF V600E-mutant mCRC were randomly assigned 1:1:1 to receive triplet, doublet, or control. Primary end points were OS and independently reviewed ORR comparing triplet to control. OS for doublet versus control was a key secondary end point. Updated analyses include 6 months of additional follow-up and ORR for all randomized patients. RESULTS: Patients received triplet (n = 224), doublet (n = 220), or control (n = 221). Median OS was 9.3 months (95% CI, 8.2 to 10.8) for triplet and 5.9 months (95% CI, 5.1 to 7.1) for control (hazard ratio [HR], 0.60 [95% CI, 0.47 to 0.75]). Median OS for doublet was 9.3 months (95% CI, 8.0 to 11.3) (HR v control, 0.61 [95% CI, 0.48 to 0.77]). Confirmed ORR was 26.8% (95% CI, 21.1% to 33.1%) for triplet, 19.5% (95% CI, 14.5% to 25.4%) for doublet, and 1.8% (95% CI, 0.5% to 4.6%) for control. Adverse events were consistent with the prior primary analysis, with grade ≥ 3 adverse events in 65.8%, 57.4%, and 64.2% for triplet, doublet, and control, respectively. CONCLUSION: In the BEACON CRC study, encorafenib plus cetuximab improved OS, ORR, and progression-free survival in previously treated patients in the metastatic setting compared with standard chemotherapy. Based on the primary and updated analyses, encorafenib plus cetuximab is a new standard ca

Published
2021

61. Contour prognostic model for predicting survival after resection of colorectal liver metastases: development and multicentre validation study using largest diameter and number of metastases with RAS mutation status

Author

Kawaguchi, Y, primary, Kopetz, S, additional, Tran Cao, H S, additional, Panettieri, E, additional, De Bellis, M, additional, Nishioka, Y, additional, Hwang, H, additional, Wang, X, additional, Tzeng, C -W D, additional, Chun, Y S, additional, Aloia, T A, additional, Hasegawa, K, additional, Guglielmi, A, additional, Giuliante, F, additional, and Vauthey, J -N, additional

Published
2021
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64. 85MO Management of adverse events associated with encorafenib plus cetuximab in patients with BRAF V600E mutant metastatic colorectal cancer (BEACON CRC Study)

Author

Chiu, C-F., primary, Yeh, Y-M., additional, Yeh, K-H., additional, Desai, J., additional, Price, T.J., additional, Tebbutt, N., additional, Tabernero, J., additional, Velez, L., additional, Trevino, T.L., additional, Grothey, A., additional, Yaeger, R., additional, Gollerkeri, A., additional, Maharry, K., additional, and Kopetz, S., additional

Published
2020
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68. LBA-7 Encorafenib plus cetuximab with or without binimetinib for BRAFV600E metastatic colorectal cancer (mCRC): Relationship between carcinoembryonic antigen (CEA) and clinical outcomes from BEACON CRC

Author

Grothey, A., primary, Kopetz, S., additional, Yaeger, R., additional, Van Cutsem, E., additional, Wasan, H., additional, Desai, J., additional, Ciardiello, F., additional, Yoshino, T., additional, Maharry, K., additional, Christy-Bittel, J., additional, Gollerkeri, A., additional, and Tabernero, J., additional

Published
2020
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70. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study

Author

Van Cutsem, E, Huijberts, S, Grothey, A, Yaeger, R, Cuyle, P-J, Elez, E, Fakih, M, Montagut, C, Peeters, M, Yoshino, T, Wasan, H, Desai, CJ, Ciardiello, F, Gollerkeri, A, Christy-Bittel, J, Maharry, K, Sandor, V, Schellens, JH, Kopetz, S, Tabernero, J, Van Cutsem, E, Huijberts, S, Grothey, A, Yaeger, R, Cuyle, P-J, Elez, E, Fakih, M, Montagut, C, Peeters, M, Yoshino, T, Wasan, H, Desai, CJ, Ciardiello, F, Gollerkeri, A, Christy-Bittel, J, Maharry, K, Sandor, V, Schellens, JH, Kopetz, S, and Tabernero, J

Abstract

PURPOSE: To determine the safety and preliminary efficacy of selective combination targeted therapy for BRAF V600E-mutant metastatic colorectal cancer (mCRC) in the safety lead-in phase of the open-label, randomized, three-arm, phase III BEACON Colorectal Cancer trial ( ClinicalTrials.gov identifier: NCT02928224; European Union Clinical Trials Register identifier: EudraCT2015-005805-35). PATIENTS AND METHODS: Before initiation of the randomized portion of the BEACON Colorectal Cancer trial, 30 patients with BRAF V600E-mutant mCRC who had experienced treatment failure with one or two prior regimens were to be recruited to a safety lead-in of encorafenib 300 mg daily, binimetinib 45 mg twice daily, plus standard weekly cetuximab. The primary end point was safety, including the incidence of dose-limiting toxicities. Efficacy end points included overall response rate, progression-free survival, and overall survival. RESULTS: Among the 30 treated patients, dose-limiting toxicities occurred in five patients and included serous retinopathy (n = 2), reversible decreased left ventricular ejection fraction (n = 1), and cetuximab-related infusion reactions (n = 2). The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%). In 29 patients with BRAF V600E-mutant tumors (one patient had a non-BRAF V600E-mutant tumor and was not included in the efficacy analysis), the confirmed overall response rate was 48% (95% CI, 29.4% to 67.5%), median progression-free survival was 8.0 months (95% CI, 5.6 to 9.3 months), and median overall survival was 15.3 months (95% CI, 9.6 months to not reached), with median duration of follow-up of 18.2 months (range, 16.6 to 19.8 months). CONCLUSION: In the safety lead-in, the safety and tolerability of the encorafenib, binimetinib, and cetuximab regimen is manageable and acceptable for initiation of the randomized portion of the study. The

Published
2019

73. Encorafenib plus cetuximab with or without binimetinib for BRAF V600E–mutant metastatic colorectal cancer: Expanded results from a randomized, 3-arm, phase III study vs the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)

Author

Tabernero, J., primary, Grothey, A., additional, Van Cutsem, E., additional, Yaeger, R., additional, Wasan, H., additional, Yoshino, T., additional, Desai, J., additional, Ciardiello, F., additional, Loupakis, F., additional, Hong, Y Sang, additional, Steeghs, N., additional, Guren, T.K., additional, Arkenau, H.-T., additional, García-Alfonso, P., additional, Gollerkeri, A., additional, Pickard, M., additional, Maharry, K., additional, Christy-Bittel, J.L., additional, Anderson, L., additional, and Kopetz, S., additional

Published
2019
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75. Triple blockade of EGFR, MEK and PD-L1 as effective antitumor treatment in PD-L1 overexpressing, MEK inhibitor resistant colon cancer cells

Author

Matrone, N., primary, Napolitano, S., additional, Belli, V., additional, Barra, G., additional, Giunta, E.F., additional, De Falco, V., additional, Terminiello, M., additional, Vitiello, P.P., additional, Ciardiello, D., additional, Turano, M., additional, Furia, M., additional, Muddassir, A.S., additional, Kopetz, S., additional, Martinelli, E., additional, Ciardiello, F., additional, and Troiani, T., additional

Published
2019
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76. BEACON CRC: a randomized, 3-Arm, phase 3 study of encorafenib and cetuximab with or without binimetinib vs. choice of either irinotecan or FOLFIRI plus cetuximab in BRAF V600E–mutant metastatic colorectal cancer

Author

Kopetz, S., primary, Grothey, A., additional, Van Cutsem, E., additional, Yaeger, R., additional, Wasan, H., additional, Yoshino, T., additional, Desai, J., additional, Ciardiello, F., additional, Gollerkeri, A., additional, Maharry, K., additional, Loupakis, F., additional, Hong, Y., additional, Steeghs, N., additional, Guren, T., additional, Arkenau, H., additional, García Alfonso, P., additional, Sandor, V., additional, Christy-Bittel, J., additional, Anderson, L., additional, and Tabernero, J., additional

Published
2019
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77. Corrections to “Phase II study of nab-paclitaxel in refractory small bowel adenocarcinoma and CpG island methylator phenotype (CIMP)-high colorectal cancer”

Author

Overman, M.J., primary, Adam, L., additional, Raghav, K., additional, Wang, J., additional, Kee, B., additional, Fogelman, D., additional, Eng, C., additional, Vilar, E., additional, Shroff, R., additional, Dasari, A., additional, Wolff, R., additional, Morris, J., additional, Karunasena, E., additional, Pisanic, T.R., additional, Azad, N., additional, and Kopetz, S., additional

Published
2019
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82. Microsatellite instability detection by targeted sequencing of cell-free DNA

Author

Artyomenko, A., primary, Sikora, M., additional, Lefterova, M., additional, Raymond, V.M., additional, Gavino, D., additional, Barbacioru, C., additional, Artieri, C., additional, Helman, E., additional, Chudova, D., additional, Lanman, R.B., additional, Odegaard, J., additional, Willis, J.A., additional, Fakih, M., additional, Kopetz, S., additional, and Talasaz, A., additional

Published
2018
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85. A novel patient derived orthotopic xenograft model of gastro-esophageal junction cancer: Key platform for translational discoveries

Author

Veeranki, O., primary, Tong, Z., additional, Mejia, A., additional, Katkhuda, R., additional, Mino, B., additional, Canales, J., additional, Garcia, A., additional, Lang, W., additional, Bassett, R., additional, Ajani, J., additional, Wu, J., additional, Kopetz, S., additional, Blum, M., additional, Hofstetter, W., additional, Kingsley, C., additional, Norton, W., additional, and Maru, D., additional

Published
2018
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86. BEACON CRC study safety lead-in: Assessment of the BRAF inhibitor encorafenib + MEK inhibitor binimetinib + anti–epidermal growth factor receptor antibody cetuximab for BRAFV600E metastatic colorectal cancer

Author

Van Cutsem, E., primary, Cuyle, P., additional, Huijberts, S., additional, Schellens, J., additional, Elez, E., additional, Yaeger, R., additional, Fakih, M., additional, Montagut, C., additional, Peeters, M., additional, Desai, J., additional, Yoshino, T., additional, Ciardiello, F., additional, Wasan, H., additional, Maharry, K., additional, Christy-Bittel, J., additional, Gollerkeri, A., additional, Kopetz, S., additional, Grothey, A., additional, and Tabernero, J., additional

Published
2018
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90. Loss of muscle mass during preoperative chemotherapy predicts worse recurrence-free survival in patients with resectable colorectal liver metastases

Author

Okuno, M., primary, Goumard, C., additional, Kopetz, S., additional, Simoneau, E.B., additional, Mizuno, T., additional, Omichi, K., additional, Tzeng, C.W.D., additional, Chun, Y.S., additional, Lee, J.E., additional, Vauthey, J.N., additional, Aloia, T.A., additional, and Conrad, C., additional

Published
2018
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91. O-0025COLORECTAL CANCER SUBTYPING CONSORTIUM (CRCSC) IDENTIFIES CONSENSUS OF MOLECULAR SUBTYPES

Author

Dienstmann, R., Guinney, J., Delorenzi, M., De Reynies, A., Roepman, P., Sadanandam, A., Vermeulen, L., Schlicker, A., Missiaglia, E., Soneson, C., Marisa, L., Homicsko, K., Wang, X., Simon, I., Laurent-Puig, P., Wessels, L., Medema, J.P., Kopetz, S., Friend, S., Tejpar, S., Group, Colorectal Cancer Subtyping Consortium, Dienstmann, R., Guinney, J., Delorenzi, M., De Reynies, A., Roepman, P., Sadanandam, A., Vermeulen, L., Schlicker, A., Missiaglia, E., Soneson, C., Marisa, L., Homicsko, K., Wang, X., Simon, I., Laurent-Puig, P., Wessels, L., Medema, J.P., Kopetz, S., Friend, S., Tejpar, S., and Group, Colorectal Cancer Subtyping Consortium

Published
2017

92. Combination of nivolumab (nivo) + ipilimumab (ipi) in the treatment of patients (pts) with deficient DNA mismatch repair (dMMR)/high microsatellite instability (MSI-H) metastatic colorectal cancer (mCRC): CheckMate 142 Study

Author

Lonardi, S., primary, Andre, T., additional, Wong, K.Y.M., additional, Morse, M., additional, McDermott, R., additional, Hill, A., additional, Hendlisz, A., additional, Lenz, H., additional, Leach, J., additional, Moss, R.A., additional, Cao, Z.A., additional, Ledeine, J., additional, Kopetz, S., additional, and Overman, M., additional

Published
2017
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93. BEACON CRC: safety lead-in (SLI) for the combination of binimetinib (BINI), encorafenib (ENCO), and cetuximab (CTX) in patients (pts) with BRAF-V600E metastatic colorectal cancer (mCRC)

Author

Huijberts, S., primary, Schellens, J.H.M., additional, Elez, E., additional, Cuyle, P-J., additional, Van Cutsem, E., additional, Yaeger, R., additional, Fakih, M., additional, Montagut, C., additional, Peeters, M., additional, Desai, J., additional, Yoshino, T., additional, Ciardiello, F., additional, Wasan, H., additional, Grothey, A., additional, Maharry, K., additional, Gollerkeri, A., additional, and Kopetz, S., additional

Published
2017
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94. Targeted methylation sequencing of plasma cell-free DNA identifies patients with advanced breast, colorectal, non-small cell lung cancer, melanoma with poor outcomes

Author

Jassowicz, A., primary, Liu, L., additional, Huang, H., additional, Hong, D.S., additional, Naing, A., additional, Subbiah, V., additional, Piha-Paul, S.A., additional, Toung, J., additional, Vijayaraghavan, R., additional, Zhang, R., additional, Kang, H., additional, Fu, S., additional, Tsimberiodou, A.M., additional, Lu, C., additional, Eng, C., additional, Moulder, S., additional, Kopetz, S., additional, Amaria, R., additional, Meric-Bernstam, F., additional, and Janku, F., additional

Published
2017
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95. Analysis of tumor PD-L1 expression and biomarkers in relation to clinical activity in patients (pts) with deficient DNA mismatch repair (dMMR)/high microsatellite instability (MSI-H) metastatic colorectal cancer (mCRC) treated with nivolumab (NIVO) + ipilimumab (IPI): CheckMate 142

Author

André, T., primary, Overman, M., additional, Lonardi, S., additional, Aglietta, M., additional, McDermott, R., additional, Wong, K.Y.M., additional, Morse, M., additional, Hendlisz, A., additional, Moss, R.A., additional, Ledeine, J.-M., additional, Tang, H., additional, Cao, Z.A., additional, and Kopetz, S., additional

Published
2017
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96. Efficacy and safety of Sym004 in refractory metastatic colorectal cancer with acquired resistance to anti-EGFR therapy: Results of a randomized phase II study (RP2S)

Author

Tabernero, J., primary, Ciardiello, F., additional, Montagut, C., additional, Ding, C., additional, Kopetz, S., additional, Tuxen Poulsen, T., additional, Bardelli, A., additional, Wyrwicz, L., additional, Cubillo, A., additional, Santos, C., additional, Fumi, G., additional, Zagonel, V., additional, Bennouna, J., additional, Siena, S., additional, Falcone, A., additional, Benavent, M., additional, Argiles, G., additional, Kragh, M., additional, Horak, I.D., additional, and Dvorkin, M., additional

Published
2017
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97. Genotyping circulating tumor DNA identifies metastatic colorectal cancer (mCRC) patients highly sensitive to Sym004

Author

Montagut Viladot, C., primary, Bardelli, A., additional, Tuxen Poulsen, T., additional, Dienstmann, R., additional, Kragh, M., additional, Kopetz, S., additional, Koefoed, K., additional, Ciardiello, F., additional, Ding, C., additional, Vidal, J., additional, Clausell-Tormos, J., additional, Siravegna, G., additional, Lindsted, T., additional, Pedersen, M.W., additional, Rospo, G., additional, Argilés Martinez, G., additional, Nadler, P., additional, Horak, I.D., additional, and Tabernero, J., additional

Published
2017
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99. Encorafenib, Binimetinib, and Cetuximab in V600E-Mutated Colorectal Cancer.

Author

Kopetz, S., Grothey, A., Yaeger, R., Van Cutsem, E., Desai, J., Yoshino, T., Wasan, H., Ciardiello, F., Loupakis, F., Hong, Y. S., Steeghs, N., Guren, T. K., Arkenau, H.-T., Garcia-Alfonso, P., Pfeiffer, P., Orlov, S., Lonardi, S., Elez, E., Kim, T.-W., and Schellens, J. H. M.

Subjects
*CETUXIMAB, *COLORECTAL cancer, *EPIDERMAL growth factor receptors, *THERAPEUTIC use of antineoplastic agents, *ANTINEOPLASTIC agents, *COLON tumors, *COMPARATIVE studies, *HETEROCYCLIC compounds, *RESEARCH methodology, *MEDICAL cooperation, *GENETIC mutation, *RESEARCH, *SULFONAMIDES, *SURVIVAL analysis (Biometry), *TRANSFERASES, *EVALUATION research, *RANDOMIZED controlled trials, *DISEASE progression, *ACYCLIC acids, *KAPLAN-Meier estimator, RECTUM tumors
Abstract

Background: Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal growth factor receptor signaling.Methods: In this open-label, phase 3 trial, we enrolled 665 patients with BRAF V600E-mutated metastatic colorectal cancer who had had disease progression after one or two previous regimens. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab (triplet-therapy group); encorafenib and cetuximab (doublet-therapy group); or the investigators' choice of either cetuximab and irinotecan or cetuximab and FOLFIRI (folinic acid, fluorouracil, and irinotecan) (control group). The primary end points were overall survival and objective response rate in the triplet-therapy group as compared with the control group. A secondary end point was overall survival in the doublet-therapy group as compared with the control group. We report here the results of a prespecified interim analysis.Results: The median overall survival was 9.0 months in the triplet-therapy group and 5.4 months in the control group (hazard ratio for death, 0.52; 95% confidence interval [CI], 0.39 to 0.70; P<0.001). The confirmed response rate was 26% (95% CI, 18 to 35) in the triplet-therapy group and 2% (95% CI, 0 to 7) in the control group (P<0.001). The median overall survival in the doublet-therapy group was 8.4 months (hazard ratio for death vs. control, 0.60; 95% CI, 0.45 to 0.79; P<0.001). Adverse events of grade 3 or higher occurred in 58% of patients in the triplet-therapy group, in 50% in the doublet-therapy group, and in 61% in the control group.Conclusions: A combination of encorafenib, cetuximab, and binimetinib resulted in significantly longer overall survival and a higher response rate than standard therapy in patients with metastatic colorectal cancer with the BRAF V600E mutation. (Funded by Array BioPharma and others; BEACON CRC ClinicalTrials.gov number, NCT02928224; EudraCT number, 2015-005805-35.). [ABSTRACT FROM AUTHOR]

Published
2019
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100. LBA32 - Encorafenib plus cetuximab with or without binimetinib for BRAF V600E–mutant metastatic colorectal cancer: Expanded results from a randomized, 3-arm, phase III study vs the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)

Author

Tabernero, J., Grothey, A., Van Cutsem, E., Yaeger, R., Wasan, H., Yoshino, T., Desai, J., Ciardiello, F., Loupakis, F., Hong, Y Sang, Steeghs, N., Guren, T.K., Arkenau, H.-T., García-Alfonso, P., Gollerkeri, A., Pickard, M., Maharry, K., Christy-Bittel, J.L., Anderson, L., and Kopetz, S.

Published
2019
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