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2. Deep and Durable Prostate-specific Antigen Response to Darolutamide with Androgen Deprivation Therapy and Docetaxel, and Association with Clinical Outcomes for Patients with High- or Low-volume Metastatic Hormone-sensitive Prostate Cancer: Analyses of the Randomized Phase 3 ARASENS Study

Author

Saad, Fred, Hussain, Maha H.A., Tombal, Bertrand, Fizazi, Karim, Sternberg, Cora N., Crawford, E. David, Nordquist, Luke T., Bögemann, Martin, Tutrone, Ronald, Shore, Neal D., Belkoff, Laurence, Fralich, Todd, Jhaveri, Jay, Srinivasan, Shankar, Li, Rui, Verholen, Frank, Kuss, Iris, and Smith, Matthew R.

Published
2024
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3. Effect of crossover from placebo to darolutamide on overall survival in men with non-metastatic prostate cancer: sensitivity analyses from the randomised phase 3 ARAMIS study

Author

Shore, Neal D., Fizazi, Karim, Tammela, Teuvo L.J., Luz, Murilo, Salas, Manuel Philco, Ouellette, Paul, Jr., Lago, Sérgio, Bastos, Diogo Assed, Jansz, G. Kenneth, Cárcano, Flavio Mavignier, Andrade, Lívia, Pliskin, Marc, Lazaretti, Nicolas, Arruda, Larissa, Correa Ochoa, José Jaime, Kuss, Iris, Kappeler, Christian, Sarapohja, Toni, and Smith, Matthew

Published
2023
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4. Darolutamide plus androgen-deprivation therapy in patients with high-risk biochemical recurrence of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP).

Author

Chehrazi-Raffle, Alex, primary, Morgans, Alicia K., additional, Gschwend, Jürgen E., additional, Shore, Neal D., additional, Ross, Ashley, additional, Feng, Felix Y, additional, Hope, Thomas A., additional, Nordquist, Luke, additional, Niazi, Tamim, additional, Trandafir, Lucia, additional, Le Berre, Marie-Aude, additional, Kuss, Iris, additional, Joensuu, Heikki, additional, and Fizazi, Karim, additional

Published
2024
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6. Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: An analysis of the phase III ARAMIS trial

Author

Smith, Matthew R., Shore, Neal, Tammela, Teuvo L., Ulys, Albertas, Vjaters, Egils, Polyakov, Sergey, Jievaltas, Mindaugas, Luz, Murilo, Alekseev, Boris, Kuss, Iris, Le Berre, Marie-Aude, Mohamed, Ateesha F., Odom, Dawn, Bartsch, Jennifer, Snapir, Amir, Sarapohja, Toni, and Fizazi, Karim

Published
2021
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7. Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-group analysis of the phase III ARAMIS trial

Author

Uemura, Hiroji, Matsushima, Hisashi, Kobayashi, Kazuki, Mizusawa, Hiroya, Nishimatsu, Hiroaki, Fizazi, Karim, Smith, Matthew, Shore, Neal, Tammela, Teuvo, Tabata, Ken-ichi, Matsubara, Nobuaki, Iinuma, Masahiro, Uemura, Hirotsugu, Oya, Mototsugu, Momma, Tetsuo, Kawakita, Mutsushi, Fukasawa, Satoshi, Kobayashi, Tadahiro, Kuss, Iris, Le Berre, Marie-Aude, Snapir, Amir, Sarapohja, Toni, and Suzuki, Kazuhiro

Published
2021
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8. Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

Author

Jones, Robert Hugh, primary, Fizazi, Karim, additional, James, Nicholas D., additional, Tammela, Teuvo L., additional, Matsubara, Nobuaki, additional, Priou, Frank, additional, Beuzeboc, Philippe, additional, Lesimple, Thierry, additional, Bono, Petri, additional, Kataja, Vesa, additional, Garcia, Jorge A., additional, Protheroe, Andrew, additional, Shore, Neal, additional, Aspegren, John, additional, Joensuu, Heikki, additional, Kuss, Iris, additional, Fiala-Buskies, Sabine, additional, and Vjaters, Egils, additional

Published
2023
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9. Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial

Author

Shore, Neal, Zurth, Christian, Fricke, Robert, Gieschen, Hille, Graudenz, Kristina, Koskinen, Mikko, Ploeger, Bart, Moss, Jonathan, Prien, Olaf, Borghesi, Gustavo, Petrenciuc, Oana, Tammela, Teuvo L., Kuss, Iris, Verholen, Frank, Smith, Matthew R., and Fizazi, Karim

Published
2019
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11. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial

Author

Hussain, Maha, primary, Tombal, Bertrand, additional, Saad, Fred, additional, Fizazi, Karim, additional, Sternberg, Cora N., additional, Crawford, E. David, additional, Shore, Neal, additional, Kopyltsov, Evgeny, additional, Kalebasty, Arash Rezazadeh, additional, Bögemann, Martin, additional, Ye, Dingwei, additional, Cruz, Felipe, additional, Suzuki, Hiroyoshi, additional, Kapur, Shivani, additional, Srinivasan, Shankar, additional, Verholen, Frank, additional, Kuss, Iris, additional, Joensuu, Heikki, additional, and Smith, Matthew R., additional

Published
2023
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12. Efficacy and safety of darolutamide (DARO) in combination with androgen-deprivation therapy (ADT) and docetaxel (DOC) by disease volume and disease risk in the phase 3 ARASENS study.

Author

Hussain, Maha H. A., primary, Tombal, Bertrand F., additional, Saad, Fred, additional, Fizazi, Karim, additional, Sternberg, Cora N., additional, Crawford, E. David, additional, Shore, Neal D., additional, Kopyltsov, Evgeny, additional, Rezazadeh, Arash, additional, Boegemann, Martin, additional, Ye, Ding-Wei, additional, Cruz, Felipe Melo, additional, Suzuki, Hiroyoshi, additional, Kapur, Shivani, additional, Srinivasan, Shankar, additional, Verholen, Frank, additional, Kuss, Iris, additional, Joensuu, Heikki, additional, and Smith, Matthew Raymond, additional

Published
2023
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13. Dosing, safety, and pharmacokinetics (PK) of combination therapy with darolutamide (DARO), androgen-deprivation therapy (ADT), and docetaxel (DOC) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the ARASENS study.

Author

Rezazadeh, Arash, primary, Tombal, Bertrand F., additional, Hussain, Maha H. A., additional, Saad, Fred, additional, Fizazi, Karim, additional, Sternberg, Cora N., additional, Crawford, E. David, additional, Kapur, Shivani, additional, Zhang, Weijiang, additional, Ploeger, Bart, additional, Li, Rui, additional, Kuss, Iris, additional, Zieschang, Carsten, additional, Wittemer-Rump, Sabine, additional, and Smith, Matthew Raymond, additional

Published
2023
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14. Stratification subgroup analysis of overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel in the phase 3 ARASENS trial

Author

Tombal, Bertrand, primary, Hussain, Maha, primary, Saad, Fred, primary, Fizazi, Karim, primary, N. Sternberg, Cora, primary, David Crawford, E, primary, Kopyltsov, Evgeny, primary, Rezazadeh Kalebasty, Arash, primary, Alekseev, Boris, primary, Montesa Pino, Álvaro, primary, Ye, Dingwei, primary, Parnis, Francis, primary, Melo Cruz, Felipe, primary, L.J. Tammela, Teuvo, primary, Suzuki, Hiroyoshi, primary, Tuomas Joensuu, Heikki, primary, Thiele, Silke, primary, Li, Rui, primary, and Kuss, Iris, primary

Published
2022
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16. Association of prostate-specific antigen (PSA) response and overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARASENS trial.

Author

Saad, Fred, primary, Hussain, Maha H. A., additional, Tombal, Bertrand F., additional, Fizazi, Karim, additional, Sternberg, Cora N., additional, Crawford, E. David, additional, Thiele, Silke, additional, Li, Rui, additional, Kuss, Iris, additional, Joensuu, Heikki, additional, and Smith, Matthew Raymond, additional

Published
2022
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17. MP27-13 LONG-TERM SAFETY OF DAROLUTAMIDE AMONG PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO RECEIVED MORE THAN 4 YEARS OF THERAPY

Author

Jones, Robert Hugh, primary, Fizazi, Karim, additional, James, Nicholas D., additional, Tammela, Teuvo L., additional, Matsubara, Nobuaki, additional, Priou, Frank, additional, Beuzeboc, Phillipe, additional, Lesimple, Thierry, additional, Bono, Petri, additional, Kataja, Vesa, additional, Garcia, Jorge A., additional, Protheroe, Andrew, additional, Aspegren, John, additional, Joensuu, Heikki, additional, Kuss, Iris, additional, Thiele, Silke, additional, Fiala-Buskies, Sabine, additional, and Vjaters, Eglis, additional

Published
2022
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18. LBA01-07 OVERALL SAFETY AND INCIDENCES OF ADVERSE EVENTS BY TIME INTERVAL WITH DAROLUTAMIDE PLUS ANDROGEN-DEPRIVATION THERAPY AND DOCETAXEL IN THE PHASE 3 ARASENS TRIAL

Author

Crawford, E. David, primary, Smith, Matthew R., additional, Tombal, Bertrand, additional, Fizazi, Karim, additional, Hussain, Maha, additional, Sternberg, Cora N., additional, Rezazadeh Kalebasty, Arash, additional, Tutrone, Ronald, additional, Shore, Neal D., additional, Belkoff, Laurence, additional, Thiele, Silke, additional, Li, Rui, additional, Kuss, Iris, additional, Joensuu, Heikki, additional, and Saad, Fred, additional

Published
2022
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19. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

Author

Smith, Matthew R, Hussain, Maha, Saad, Fred, Fizazi, Karim, Sternberg, Cora N, Crawford, E David, Kopyltsov, Evgeny, Park, Chandler H, Alekseev, Boris, Montesa-Pino, Álvaro, Dingwei, Ye, Parnis, Francis, Cruz, Felipe, Tammela, Teuvo L J, Suzuki, Hiroyoshi, Utriainen, Tapio, Cheng, Fu, Uemura, Motohide, Méndez-Vidal, María J, Maughan, Benjamin L, Joensuu, Heikki, Thiele, Silke, Rui, Li, Kuss, Iris, Tombal, Bertrand, Arasens, Investigators, Milella, Michele, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, and UCL - (SLuc) Service d'urologie

Subjects
Aged, 80 and over, Male, Neutropenia, Prostatic Neoplasms, Androgen Antagonists, Antineoplastic Agents, General Medicine, Docetaxel, Kaplan-Meier Estimate, Middle Aged, Castration-Resistant, Prostatic Neoplasms, Castration-Resistant, Drug Therapy, Combination, Medicine and Health Sciences, 80 and over, Androgen Receptor Antagonists, Humans, Pyrazoles, Drug Therapy, Combination, Neoplasm Metastasis, Aged, Proportional Hazards Models
Abstract

BACKGROUND Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown. METHODS In this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival. RESULTS The primary analysis involved 1306 patients (651 in the darolutamide group and 655 in the placebo group); 86.1% of the patients had disease that was metastatic at the time of the initial diagnosis. At the data cutoff date for the primary analysis (October 25, 2021), the risk of death was significantly lower, by 32.5%, in the darolutamide group than in the placebo group (hazard ratio 0.68; 95% confidence interval, 0.57 to 0.80; P= 10% of the patients) were highest during the overlapping docetaxel treatment period in both groups. The frequency of grade 3 or 4 adverse events was 66.1% in the darolutamide group and 63.5% in the placebo group; neutropenia was the most common grade 3 or 4 adverse event (in 33.7% and 34.2%, respectively). CONCLUSIONS In this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. (Funded by Bayer and Orion Pharma; ARASENS ClinicalTrials.gov number, .) Darolutamide in Metastatic Prostate Cancer Standard therapy for metastatic, hormone-sensitive prostate cancer is androgen-deprivation therapy, usually with docetaxel. A large, multinational, phase 3 trial assessed the addition of the androgen-receptor blocker darolutamide to standard therapy. At 4 years, survival was higher with darolutamide than with placebo (62.7% vs. 50.4%), with no major differences in the frequency of adverse events.

Published
2022

20. Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer.

Author

Vjaters, Egils, primary, Fizazi, Karim, additional, James, Nicholas D., additional, Tammela, Teuvo, additional, Matsubara, Nobuaki, additional, Priou, Frank, additional, Lesimple, Thierry, additional, Bono, Petri, additional, Kataja, Vesa V, additional, Garcia, Jorge A., additional, Protheroe, Andrew, additional, Aspegren, John, additional, Joensuu, Heikki, additional, Kuss, Iris, additional, Thiele, Silke, additional, Fiala-Buskies, Sabine, additional, and Jones, Robert Hugh, additional

Published
2022
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21. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial.

Author

Smith, Matthew Raymond, primary, Hussain, Maha H. A., additional, Saad, Fred, additional, Fizazi, Karim, additional, Sternberg, Cora N., additional, Crawford, E. David, additional, Kopyltsov, Evgeny, additional, Park, Chandler H., additional, Alexeev, Boris, additional, Montesa, Alvaro, additional, Ye, Dingwei, additional, Parnis, Francis, additional, Cruz, Felipe Melo, additional, Tammela, Teuvo, additional, Suzuki, Hiroyoshi, additional, Joensuu, Heikki, additional, Thiele, Silke, additional, Li, Rui, additional, Kuss, Iris, additional, and Tombal, Bertrand F., additional

Published
2022
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22. A randomized, controlled, phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus ADT alone in metastatic hormone-sensitive prostate cancer (ARANOTE).

Author

KP, Haresh, primary, Vjaters, Egils, additional, Castellano, Daniel, additional, Olmos, David, additional, Shore, Neal D., additional, Nevalaita, Liina, additional, Testa, Isabella, additional, Kappeler, Christian, additional, Kuss, Iris, additional, and Saad, Fred, additional

Published
2022
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23. Darolutamide (DARO) tolerability from extended follow up and treatment response in the phase 3 ARAMIS trial.

Author

Fizazi, Karim, primary, Shore, Neal D., additional, Smith, Matthew Raymond, additional, Tammela, Teuvo, additional, Pieczonka, Christopher Michael, additional, Aragon-Ching, Jeanny B., additional, Morris, David, additional, Le Berre, Marie-Aude, additional, Srinivasan, Shankar, additional, Petrenciuc, Oana, additional, Zurth, Christian, additional, and Kuss, Iris, additional

Published
2021
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24. Safety of darolutamide (DARO) for nonmetastatic castration-resistant prostate cancer (nmCRPC) from extended follow-up in the phase III ARAMIS trial.

Author

Smith, Matthew Raymond, primary, Fizazi, Karim, additional, Tammela, Teuvo L. J., additional, Cruz, Felipe Melo, additional, Nordquist, Luke T., additional, Aleman Polanco, Diana Sofia, additional, Emmenegger, Urban, additional, Silveira, Glauco Costa, additional, Concepcion, Raoul S., additional, Paula, Adriano, additional, de Mendonça Beato, Carlos Augusto, additional, Fleshner, Neil, additional, Richardet, Martin Eduardo, additional, Kuss, Iris, additional, Le Berre, Marie-Aude, additional, Borghesi, Gustavo, additional, Sarapohja, Toni, additional, and Shore, Neal D., additional

Published
2021
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25. Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-group analysis of the phase III ARAMIS trial

Author

Uemura, Hiroji, primary, Matsushima, Hisashi, additional, Kobayashi, Kazuki, additional, Mizusawa, Hiroya, additional, Nishimatsu, Hiroaki, additional, Fizazi, Karim, additional, Smith, Matthew, additional, Shore, Neal, additional, Tammela, Teuvo, additional, Tabata, Ken-ichi, additional, Matsubara, Nobuaki, additional, Iinuma, Masahiro, additional, Uemura, Hirotsugu, additional, Oya, Mototsugu, additional, Momma, Tetsuo, additional, Kawakita, Mutsushi, additional, Fukasawa, Satoshi, additional, Kobayashi, Tadahiro, additional, Kuss, Iris, additional, Le Berre, Marie-Aude, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Suzuki, Kazuhiro, additional

Published
2020
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26. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide

Author

Fizazi, Karim, primary, Shore, Neal, additional, Tammela, Teuvo L., additional, Ulys, Albertas, additional, Vjaters, Egils, additional, Polyakov, Sergey, additional, Jievaltas, Mindaugas, additional, Luz, Murilo, additional, Alekseev, Boris, additional, Kuss, Iris, additional, Le Berre, Marie-Aude, additional, Petrenciuc, Oana, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Smith, Matthew R., additional

Published
2020
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27. Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for nonmetastatic castration-resistant prostate cancer (nmCRPC).

Author

Fizazi, Karim, primary, Shore, Neal D., additional, Tammela, Teuvo, additional, Ulys, Albertas, additional, Vjaters, Egils, additional, Polyakov, Sergey, additional, Jievaltas, Mindaugas, additional, Luz, Murilo, additional, Alekseev, Boris, additional, Kuss, Iris, additional, Le Berre, Marie-Aude, additional, Petrenciuc, Oana, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Smith, Matthew Raymond, additional

Published
2020
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28. Significant localized reduction in cerebral blood flow (CBF) in regions relevant to cognitive function with enzalutamide (ENZA) compared to darolutamide (DARO) and placebo (PBO) in healthy volunteers.

Author

Williams, Steven, primary, Mazibuko, Ndaba, additional, O’Daly, Owen, additional, Zurth, Christian, additional, Patrick, Fiona, additional, Wooldridge, Caroline, additional, Graudenz, Kristina, additional, Kuss, Iris, additional, and Cole, Patricia, additional

Published
2020
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33. Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC).

Author

Fizazi, Karim, primary, Shore, Neal D., additional, Tammela, Teuvo, additional, Kuss, Iris, additional, Le Berre, Marie-Aude, additional, Mohamed, Ateesha F., additional, Odom, Dawn, additional, Bartsch, Jennifer, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Smith, Matthew Raymond, additional

Published
2019
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34. LBA-09 DAROLUTAMIDE DELAYS PROSTATE-SPECIFIC ANTIGEN PROGRESSION AND TIME TO NEXT ANTICANCER THERAPIES IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Author

Shore*, Neal D., primary, Smith, Matthew R., additional, Tammela, Tuevo L.J., additional, Ulys, Albertas, additional, Vjaters, Eglis, additional, Polyakov, Sergey, additional, Jievaltas, Mindaugas, additional, Luz, Murilo, additional, Alekseev, Boris, additional, Kuss, Iris, additional, Le Berre, Marie A., additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Fizazi, Karim, additional

Published
2019
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35. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer

Author

Fizazi, Karim, primary, Shore, Neal, additional, Tammela, Teuvo L., additional, Ulys, Albertas, additional, Vjaters, Egils, additional, Polyakov, Sergey, additional, Jievaltas, Mindaugas, additional, Luz, Murilo, additional, Alekseev, Boris, additional, Kuss, Iris, additional, Kappeler, Christian, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Smith, Matthew R., additional

Published
2019
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36. ARAMIS: Efficacy and safety of darolutamide in nonmetastatic castration-resistant prostate cancer (nmCRPC).

Author

Fizazi, Karim, primary, Shore, Neal D., additional, Tammela, Teuvo, additional, Ulys, Albertas, additional, Vjaters, Egils, additional, Polyakov, Sergey, additional, Jievaltas, Mindaugas, additional, Luz, Murilo, additional, Alekseev, Boris Y., additional, Kuss, Iris, additional, Kappeler, Christian, additional, Snapir, Amir, additional, Sarapohja, Toni, additional, and Smith, Matthew Raymond, additional

Published
2019
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42. Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU): GRID trial

Author

Demetri, George D., Reichardt, Peter, Kang, Yoon-Koo, Jean-Yves Blay, Joensuu, Heikki, Maki, Robert G., Rutkowski, Piotr, Hohenberger, Peter, Gelderblom, Hans, Leahy, Michael Gordon, Mehren, Margaret, Schoffski, Patrick, Blackstein, Martin E., Le Cesne, Axel, Badalamenti, Giuseppe, Xu, Jian-Ming, Nishida, Toshirou, Laurent, Dirk, Kuss, Iris, Casali, Paolo Giovanni, and Invest, Grid

Subjects
Cancer Research, Oncology
Abstract

LBA10008 Background: Oral multikinase inhibitor regorafenib (REG) demonstrated substantial activity in a phase II trial in pts with GIST after failure of both IM and SU (J Clin Oncol. 2011; 29:606s; abstr 10007). This phase III, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of REG for this unmet clinical need. Methods: Eligible pts had metastatic and/or unresectable GIST, objective failure of both prior IM and SU (progressive disease [PD] on, or intolerance to, IM and PD on SU), ≥1 measurable lesion, ECOG performance status 0 or 1. Pts were randomized 2:1 to receive best supportive care plus either REG 160 mg po once daily (3 wks on/1 wk off) or placebo (PL). The primary endpoint was progression-free survival (PFS) (modified RECIST 1.1, independent central review). Secondary endpoints included overall survival (OS), disease control rate (DCR, defined as rate of partial response [PR] plus stable disease [SD] lasting for ≥12 wks), response rate and duration, safety and correlative genotype analyses. At time of PD, pts were eligible for unblinding and crossover to open-label REG. Results: Between Jan and Aug of 2011, 234 pts were screened; 199 were randomized (REG: 133, PL: 66). Pts were stratified at randomization according to number of prior systemic therapies and geographical region. Baseline characteristics were balanced between the two arms. The primary endpoint was met: median PFS was 4.8 months for REG vs. 0.9 months for PL. Hazard ratio for PFS was 0.27 (95% CI, 0.18-0.39), p grade 3 treatment-emergent AEs in the REG arm during double-blind study were hypertension (28%), hand-foot skin reaction (21%), and diarrhea (8%). Conclusions: This randomized trial demonstrated that REG significantly improved PFS and DCR in pts with advanced GIST after failure of at least prior IM and SU. REG was well tolerated, with AEs as expected for this class and manageable with dose modifications.

Published
2012

43. Abstract 929: Tumor genotyping in the phase III GRID study of regorafenib vs placebo in tyrosine kinase inhibitor (TKI)-refractory GIST: Detection of KIT mutations in circulating tumor DNA comparing digital PCR and massive parallel sequencing

Author

Jeffers, Michael, primary, Seidel, Henrik, additional, Schwenke, Susanne, additional, Reischl, Joachim, additional, Rutstein, Mark, additional, Kappeler, Christian, additional, Kuss, Iris, additional, and Teufel, Michael, additional

Published
2015
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44. An updated overall survival analysis with correction for protocol-planned crossover of the international, phase III, randomized, placebo-controlled trial of regorafenib in advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID).

Author

Demetri, George D., primary, Reichardt, Peter, additional, Kang, Yoon-Koo, additional, Blay, Jean-Yves, additional, Joensuu, Heikki, additional, Schaefer, Klaus Bernd, additional, Kuss, Iris, additional, Kappeler, Christian, additional, and Casali, Paolo Giovanni, additional

Published
2015
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46. Adjuvant Regorafenib in Stage IV Colorectal Cancer (CRC) After Curative Treatment of Liver Metastases: A Phase III Randomized, Placebo-Controlled Study (COAST)

Author

Van Cutsem Eric, Choti Michael, Grothey Axel, Zalcberg John, Rutstein Mark, Sargent Daniel, Xu Rui-Hua, Cupit Lisa, Yoshino Takayuki, and Kuss Iris

Subjects
medicine.medical_specialty, Randomization, Surrogate endpoint, business.industry, General surgery, medicine.medical_treatment, Hematology, Chemotherapy regimen, law.invention, chemistry.chemical_compound, Oncology, Randomized controlled trial, chemistry, law, Regorafenib, medicine, Clinical endpoint, Off Treatment, business, Neoadjuvant therapy
Abstract

Background: Complete resection and pre-/peri-/post-operative chemotherapy are the standard of care for patients with stage IV CRC and resectable metastases confined to the liver. Despite this treatment approach, long-term disease-free survival of patients with resected liver metastases is poor. The oral multikinase inhibitor REG significantly improved overall survival (OS) in patients with metastatic CRC that had progressed after all standard therapies (CORRECT study; HR 0.77; one-sided p = 0.0052; Lancet 2013). COAST will evaluate the efficacy and safety of REG vs PBO in patients with CRC after curative resection of liver metastases and completion of planned chemotherapy. Trial design: This double-blind, PBO-controlled, multicenter, phase III study (ClinicalTrials.gov identifier NCT01939223) will randomize patients (n = 750 planned) 1 : 1 to treatment with oral REG 160 mg or PBO once daily in 4-week cycles of 3 weeks on, 1 week off treatment. Doses of study drug may be delayed or reduced to manage clinically significant drug-related toxicities. Treatment will continue for 2 years or until recurrence of CRC, death, intolerable toxicity, or patient/investigator decision to stop. Inclusion criteria include age ≥18 years, stage IV CRC, pathology-proven complete resection of liver metastases, and ECOG performance status 0 or 1. Patients must have completed adjuvant, neoadjuvant, or perioperative chemotherapy. Randomization will be stratified by number of preoperative liver metastases ( 6 months), and time since last surgery for any CRC lesion (≤6 months vs >6 months). The primary endpoint is disease-free survival (DFS), assessed by the investigator using computed tomography or magnetic resonance imaging. Secondary endpoints include OS, health-related quality of life, and biomarker evaluations. Analyses will be performed when approximately 317 DFS events are observed, at which time the study will have 90% power to detect a 50% improvement in median DFS. The first patient entered the study in February 2014 and the estimated primary completion date is March 2018.Previously presented at WCGI 2014 abstract number: 749 (to be presented at WCGI 2014 as a poster presentation). Disclosure: A. Grothey: has the following financial disclosures: Advisory board: Bayer Corporate sponsored research: Bayer, Genentech, Eisai, Pfizer, ImClone, Daiichi; T. Yoshino: has the following financial disclosures: Corporate sponsored research: Daiichi Sankyo, Taiho, Bayer, Eli Lilly, Pfizer, Chugai, and Yakult; J. Zalcberg: has the following financial disclosures: Advisory board: Bayer, Roche Research and travel support, expert testimony: Bayer, Roche; D.J. Sargent: has the following financial disclosures: Advisory board: Bayer, Roche Corporate sponsored research: Roche, Celgene; M. Choti: has the following financial disclosures: Research consultant: Bristol Myers Squibb; M. Rutstein: has the following financial disclosures: Employment: Bayer HealthCare; L. Cupit: has the following financial disclosures: Employment: Bayer; I. Kuss: has the following financial disclosures: Employment: Bayer Pharma AG; E. Van Cutsem: has the following financial disclosures: Corporate sponsored research: Bayer . All other authors have declared no conflicts of interest.

Published
2014

47. Results from a phase III trial (GRID) evaluating regorafenib (REG) in metastatic gastrointestinal stromal tumour (GIST): Subgroup analysis of outcomes based on pretreatment characteristics.

Author

Joensuu, Heikki, primary, Casali, Paolo Giovanni, additional, Reichardt, Peter, additional, Kang, Yoon-Koo, additional, Blay, Jean-Yves, additional, Rutkowski, Piotr, additional, Gelderblom, Hans, additional, Hohenberger, Peter, additional, Leahy, Michael Gordon, additional, von Mehren, Margaret, additional, Badalamenti, Giuseppe, additional, Blackstein, Martin E., additional, Le Cesne, Axel, additional, Schoffski, Patrick, additional, Maki, Robert G., additional, Xu, Jian-Ming, additional, Nishida, Toshirou, additional, Kappeler, Christian, additional, Kuss, Iris, additional, and Demetri, George D., additional

Published
2013
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48. Mutational analysis of plasma DNA from patients (pts) in the phase III GRID study of regorafenib (REG) versus placebo (PL) in tyrosine kinase inhibitor (TKI)-refractory GIST: Correlating genotype with clinical outcomes.

Author

Demetri, George D., primary, Jeffers, Michael, additional, Reichardt, Peter, additional, Kang, Yoon-Koo, additional, Blay, Jean-Yves, additional, Rutkowski, Piotr, additional, Gelderblom, Hans, additional, Hohenberger, Peter, additional, Leahy, Michael Gordon, additional, von Mehren, Margaret, additional, Joensuu, Heikki, additional, Badalamenti, Giuseppe, additional, Blackstein, Martin E., additional, Le Cesne, Axel, additional, Schoffski, Patrick, additional, Maki, Robert G., additional, Xu, Jian-Ming, additional, Nishida, Toshirou, additional, Kuss, Iris, additional, and Casali, Paolo Giovanni, additional

Published
2013
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49. Abstract LB-295: Detection of oncogenic kinase mutations in circulating plasma DNA and correlation with clinical benefit in the phase III GRID study of regorafenib vs placebo in TKI-refractory metastatic GIST.

Author

Demetri, George D., primary, Jeffers, Michael, additional, Reichardt, Peter, additional, Kang, Yoon-Koo, additional, Blay, Jean-Yves, additional, Rutkowski, Piotr, additional, Gelderblom, Hans, additional, Hohenberger, Peter, additional, Leahy, Michael, additional, von Mehren, Margaret, additional, Joensuu, Heikki, additional, Badalamenti, Giuseppe, additional, Blackstein, Martin, additional, Le Cesne, Axel, additional, Schöffski, Patrick, additional, Maki, Robert G, additional, Bauer, Sebastian, additional, Bui Nguyen, Binh, additional, Xu, Jianming, additional, Nishida, Toshirou, additional, Chung, John, additional, Lathia, Chetan D., additional, Kappeler, Christian, additional, Kuss, Iris, additional, Laurent, Dirk, additional, and Casali, Paolo G, additional

Published
2013
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50. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial

Author

Demetri, George D, primary, Reichardt, Peter, additional, Kang, Yoon-Koo, additional, Blay, Jean-Yves, additional, Rutkowski, Piotr, additional, Gelderblom, Hans, additional, Hohenberger, Peter, additional, Leahy, Michael, additional, von Mehren, Margaret, additional, Joensuu, Heikki, additional, Badalamenti, Giuseppe, additional, Blackstein, Martin, additional, Le Cesne, Axel, additional, Schöffski, Patrick, additional, Maki, Robert G, additional, Bauer, Sebastian, additional, Nguyen, Binh Bui, additional, Xu, Jianming, additional, Nishida, Toshirou, additional, Chung, John, additional, Kappeler, Christian, additional, Kuss, Iris, additional, Laurent, Dirk, additional, and Casali, Paolo G, additional

Published
2013
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