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Start Over Author "Baron-Hay S" Publisher american society of clinical oncology
4 results on '"Baron-Hay S"'

1. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, Lorusso, Domenica, Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, and Lorusso, Domenica

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023

2. BRAF mutations in low-grade serous ovarian cancer and response to BRAF inhibition.

Author

Jones M., Patch A.-M., Alsop K., Ball C., Young C., Schmidt T., Shirley H., Viduka S., Bilic S., Glavinas L., Brooks J., Traficante N., Stuart-Harris R., Kirsten F., Rutovitz J., Clingan P., Glasgow A., Valmadre S., Young B., Camaris C., Crouch R., Edwards L., Hacker N., Marsden D., Robertson G., Beale P., Beith J., Carter J., Dalrymple C., Houghton R., Russell P., Links M., Grygiel J., Hill J., Brand A., Byth K., Jaworski R., Sharma R., Harnett P., Wain G., Friedlander M., Ward B., Papadimos D., Crandon A., Cummings M., Horwood K., Obermair A., Perrin L., Wyld D., Nicklin J., Davy M., Oehler M.K., Hall C., Dodd T., Healy T., Pittman K., Henderson D., Miller J., Pierdes J., Blomfield P., Challis D., McIntosh R., Parker A., Brown B., Rome R., Allen D., Grant P., Hyde S., Laurie R., Robbie M., Healy D., Manolitsas T., McNealage J., Rogers P., Susil B., Sumithran E., Simpson I., Phillips K., Rischin D., Fox S., Johnson D., Lade S., Loughrey M., O'Callaghan N., Murray W., Waring P., Billson V., Pyman J., Neesham D., Quinn M., Underhill C., Ng L.F., Blum R., Ganju V., Hammond I., Leung Y., McCartney A., Buck M., Haviv I., Purdie D., Whiteman D., Zeps N., Bell R., Jobling T., Tran H., Moujaber T., Etemadmoghadam D., Kennedy C.J., Chiew Y.E., Balleine R.L., Saunders C., Wain G.V., Gao B., Hogg R., Srirangan S., Kan C., Fereday S., Pearson J.V., Waddell N., Grimmond S.M., Dobrovic A., Bowtell D.D.L., Harnett P.R., deFazio A., Bowtell D., Chenevix-Trench G., Green A., Webb P., Gertig D., Moore S., Harrap K., Sadkowsky T., Pandeya N., Hung J., Malt M., Alexander B., Ashover P., Brown S., Corrish T., Green L., Jackman L., Ferguson K., Martin K., Martyn A., Ranieri B., Mellon A., Robertson R., Vanden Bergh T., Mackenzie P., Maidens J., Nattress K., Stenlake A., Sullivan H., White J., Jayde V., Mamers P., Bowes L., Galletta L., Giles D., Hendley J., Proietto A., Braye S., Otton G., Shannon J., Bonaventura T., Stewart J., Begbie S., Bell D., Baron-Hay S., Ferrier A., Gard G., Nevell D., Pavlakis N., Jones M., Patch A.-M., Alsop K., Ball C., Young C., Schmidt T., Shirley H., Viduka S., Bilic S., Glavinas L., Brooks J., Traficante N., Stuart-Harris R., Kirsten F., Rutovitz J., Clingan P., Glasgow A., Valmadre S., Young B., Camaris C., Crouch R., Edwards L., Hacker N., Marsden D., Robertson G., Beale P., Beith J., Carter J., Dalrymple C., Houghton R., Russell P., Links M., Grygiel J., Hill J., Brand A., Byth K., Jaworski R., Sharma R., Harnett P., Wain G., Friedlander M., Ward B., Papadimos D., Crandon A., Cummings M., Horwood K., Obermair A., Perrin L., Wyld D., Nicklin J., Davy M., Oehler M.K., Hall C., Dodd T., Healy T., Pittman K., Henderson D., Miller J., Pierdes J., Blomfield P., Challis D., McIntosh R., Parker A., Brown B., Rome R., Allen D., Grant P., Hyde S., Laurie R., Robbie M., Healy D., Manolitsas T., McNealage J., Rogers P., Susil B., Sumithran E., Simpson I., Phillips K., Rischin D., Fox S., Johnson D., Lade S., Loughrey M., O'Callaghan N., Murray W., Waring P., Billson V., Pyman J., Neesham D., Quinn M., Underhill C., Ng L.F., Blum R., Ganju V., Hammond I., Leung Y., McCartney A., Buck M., Haviv I., Purdie D., Whiteman D., Zeps N., Bell R., Jobling T., Tran H., Moujaber T., Etemadmoghadam D., Kennedy C.J., Chiew Y.E., Balleine R.L., Saunders C., Wain G.V., Gao B., Hogg R., Srirangan S., Kan C., Fereday S., Pearson J.V., Waddell N., Grimmond S.M., Dobrovic A., Bowtell D.D.L., Harnett P.R., deFazio A., Bowtell D., Chenevix-Trench G., Green A., Webb P., Gertig D., Moore S., Harrap K., Sadkowsky T., Pandeya N., Hung J., Malt M., Alexander B., Ashover P., Brown S., Corrish T., Green L., Jackman L., Ferguson K., Martin K., Martyn A., Ranieri B., Mellon A., Robertson R., Vanden Bergh T., Mackenzie P., Maidens J., Nattress K., Stenlake A., Sullivan H., White J., Jayde V., Mamers P., Bowes L., Galletta L., Giles D., Hendley J., Proietto A., Braye S., Otton G., Shannon J., Bonaventura T., Stewart J., Begbie S., Bell D., Baron-Hay S., Ferrier A., Gard G., Nevell D., and Pavlakis N.

Abstract

Purpose Low-grade serous ovarian carcinoma (LGSC) responds poorly to chemotherapy and is characterized by activating mutations in the Ras sarcoma-mitogen-activated protein kinase (RAS-MAPK) pathway, including oncogenic BRAF. However, response to BRAF inhibitors is tumor-type specific. Significant improvement in survival is seen in patients with BRAF-mutant melanoma, but other cancer types, such as colorectal cancers, are generally less sensitive. We examined the frequency and characteristics of BRAF-mutated LGSC and described the response to treatment with BRAF inhibitors. Patients and Methods Mutations were assessed in LGSC (N = 65) by using targeted, exome, and whole-genome sequencing. Patient characteristics, treatment, and clinical outcome were assessed, and the median follow-up time was more than 5 years. BRAF inhibitors were trialed in two patients with a somatic BRAF V600E mutation: one patient received dabrafenib monotherapy and was monitored clinically, biochemically (cancer antigen [CA]-125 levels), and with positron emission tomography (PET) imaging. Expression of the BRAF V600E protein in this patient was assessed by immunohistochemistry. Results Among patients with LGSC, nine (13.8%) of 65 had a somatic BRAF mutation. Of the nine patients with BRAF mutation-positive LGSC, four experienced progressive disease that did not respond to conventional chemotherapy. Two of the patients experienced progression quickly and died as a result of disease progression, and two received targeted treatment. Two patients with BRAF V600E mutation received BRAF inhibitors at relapse and both achieved durable responses. Conclusion BRAF mutations are not uncommon in patients with LGSC and should be routinely tested, because BRAF inhibitors can be an effective treatment for these patients. The results highlight the need for targeted treatment in this rare tumor type, and a prospective study is needed to formally assess the response rate and clinical benefit.Copyright © 2019 Am

Published
2019

3. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Vicky Makker, Nicoletta Colombo, Antonio Casado Herráez, Bradley J. Monk, Helen Mackay, Alessandro D. Santin, David S. Miller, Richard G. Moore, Sally Baron-Hay, Isabelle Ray-Coquard, Kimio Ushijima, Kan Yonemori, Yong Man Kim, Eva M. Guerra Alia, Ulus A. Sanli, Steven Bird, Robert Orlowski, Jodi McKenzie, Chinyere Okpara, Gianmaria Barresi, Domenica Lorusso, Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, and Lorusso, D

Subjects
Cancer Research, Oncology, Endometrial Cancer
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported. Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023

4. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775.

Author

Makker V, Colombo N, Casado Herráez A, Monk BJ, Mackay H, Santin AD, Miller DS, Moore RG, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim YM, Guerra Alia EM, Sanli UA, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, and Lorusso D

Subjects
Female, Humans, Phenylurea Compounds adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Endometrial Neoplasms drug therapy
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m 2 intravenously once every 3 weeks or paclitaxel 80 mg/m 2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023
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