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2. Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial

Author

Davar, Diwakar, Morrison, Robert M., Dzutsev, Amiran K., Karunamurthy, Arivarasan, Chauvin, Joe-Marc, Amatore, Florent, Deutsch, Julie S., Das Neves, Rodrigo X., Rodrigues, Richard R., McCulloch, John A., Wang, Hong, Hartman, Douglas J., Badger, Jonathan H., Fernandes, Miriam R., Bai, Yulong, Sun, Jie, Cole, Alicia M., Aggarwal, Poonam, Fang, Jennifer R., Deitrick, Christopher, Bao, Riyue, Duvvuri, Umamaheswar, Sridharan, Shaum S., Kim, Seungwon W., A. Choudry, Haroon, Holtzman, Matthew P., Pingpank, James F., O'Toole, James Patrick, DeBlasio, Richelle, Jin, Yang, Ding, Quanquan, Gao, Wentao, Groetsch, Christopher, Pagliano, Ornella, Rose, Amy, Urban, Corey, Singh, Jagjit, Divarkar, Prajan, Mauro, David, Bobilev, Dmitri, Wooldridge, James, Krieg, Arthur M., Fury, Matthew G., Whiteaker, Jeffrey R., Zhao, Lei, Paulovich, Amanda G., Najjar, Yana G., Luke, Jason J., Kirkwood, John M., Taube, Janis M., Park, Hyun Jung, Trinchieri, Giorgio, and Zarour, Hassane M.

Published
2024
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3. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Author

Hughes, Brett G.M., Guminski, Alexander, Bowyer, Samantha, Migden, Michael R., Schmults, Chrysalyne D., Khushalani, Nikhil I., Chang, Anne Lynn S., Grob, Jean-Jacques, Lewis, Karl D., Ansstas, George, Day, Fiona, Ladwa, Rahul, Stein, Brian N., Muñoz Couselo, Eva, Meier, Friedegund, Hauschild, Axel, Schadendorf, Dirk, Basset-Seguin, Nicole, Modi, Badri, Dalac-Rat, Sophie, Dunn, Lara A., Flatz, Lukas, Mortier, Laurent, Guégan, Sarah, Heinzerling, Lucie M., Mehnert, Janice M., Trabelsi, Sabiha, Soria-Rivas, Ainara, Stratigos, Alexander J., Ulrich, Claas, Wong, Deborah J., Beylot-Barry, Marie, Bossi, Paolo, Bugés Sánchez, Cristina, Chandra, Sunandana, Robert, Caroline, Russell, Jeffery S., Silk, Ann W., Booth, Jocelyn, Yoo, Suk-Young, Seebach, Frank, Lowy, Israel, Fury, Matthew G., and Rischin, Danny

Published
2024
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4. Neoadjuvant cemiplimab and surgery for stage II–IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study

Author

Gross, Neil D, Miller, David M, Khushalani, Nikhil I, Divi, Vasu, Ruiz, Emily S, Lipson, Evan J, Meier, Friedegund, Su, Yungpo Bernard, Swiecicki, Paul L, Atlas, Jennifer, Geiger, Jessica L, Hauschild, Axel, Choe, Jennifer H, Hughes, Brett G M, Schadendorf, Dirk, Patel, Vishal A, Homsi, Jade, Taube, Janis M, Lim, Annette M, Ferrarotto, Renata, Yoo, Suk-Young, Mathias, Melissa, Han, Hyunsil, Seebach, Frank, Lowy, Israel, Fury, Matthew G, and Rischin, Danny

Published
2023
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5. Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer.

Author

Lorusso, Domenica, primary, Oaknin, Ana, additional, Santos Borges, Giuliano, additional, Damian, Fernanda, additional, Ottevanger, P. B., additional, Van Gorp, Toon, additional, Paiva, Carlos Eduardo, additional, Kroep, Judith R., additional, Kim, Yong Man, additional, Kim, Hee Seung, additional, Lee, Jae-Kwan, additional, Melief, Cornelis JM, additional, Hooftman, Leon, additional, Jamil, Shaheda Jamil, additional, Yoo, Suk-Young, additional, Seebach, Frank A., additional, Lowy, Israel, additional, Fury, Matthew G., additional, Mathias, Melissa Divya, additional, and Colombo, Nicoletta, additional

Published
2024
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6. A phase 3 trial of fixed dose combinations of fianlimab (anti–LAG-3) + cemiplimab (anti–PD-1) versus relatlimab + nivolumab in patients with unresectable or metastatic melanoma.

Author

Khushalani, Nikhil I., primary, Mani, Jayakumar, additional, Booth, Jocelyn, additional, Zhang, Zoe, additional, Salvati, Mark, additional, Lowy, Israel, additional, Fury, Matthew G., additional, Lewis, Karl, additional, Manvelian, Garen, additional, and Tawbi, Hussein A., additional

Published
2024
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7. A phase 2/3 study of fianlimab, cemiplimab, plus chemotherapy versus cemiplimab plus chemotherapy in first-line treatment of advanced non-small cell lung cancer.

Author

Gabrail, Nashat, primary, Gogishvili, Miranda, additional, Makharadze, Tamta, additional, Chikhladze, Nana, additional, Faulkner, Neil E., additional, Nair, Santosh, additional, Ibrahim, Emad, additional, Brungs, Daniel, additional, Dreisbach, Luke, additional, Kunta, Gopal, additional, Peters, Solange, additional, Nguyen, Christopher, additional, Ghattas, Maria, additional, Li, Siyu, additional, Salvati, Mark, additional, Lowy, Israel, additional, Fury, Matthew G., additional, Paoluzzi, Luca, additional, and Melkadze, Tamar, additional

Published
2024
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8. A phase 2/3 study of fianlimab plus cemiplimab versus cemiplimab in patients with advanced non-small cell lung cancer with tumors expressing PD-L1 ≥50%.

Author

Faulkner, Neil E., primary, Melkadze, Tamar, additional, Nair, Santosh, additional, Gabrail, Nashat, additional, Kunta, Gopal, additional, Ibrahim, Emad, additional, Dreisbach, Luke, additional, Brungs, Daniel, additional, Chikhladze, Nana, additional, Gogishvili, Miranda, additional, Vokes, Natalie I, additional, Hiley, Tara, additional, Nguyen, Christopher, additional, Ghattas, Maria, additional, Li, Siyu, additional, Salvati, Mark, additional, Lowy, Israel, additional, Fury, Matthew G., additional, and Paoluzzi, Luca, additional

Published
2024
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11. Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial.

Author

Stratigos, Alexander J, Chen, Chieh-I, Ivanescu, Cristina, Lewis, Karl D, Peris, Ketty, Bechter, Oliver, Harnett, James, Mastey, Vera, Reaney, Matthew, Daskalopoulou, Christina, LaFontaine, Patrick R, Konidaris, Gerasimos, Bury, Denise, Yoo, Suk-Young, Mohan, Kosalai, Coates, Ebony, Bowler, Timothy, Fury, Matthew G, and Sekulic, Aleksandar

Abstract

Aim: To evaluate health-related quality of life (HRQoL) in cemiplimab-treated patients with locally advanced basal cell carcinoma (laBCC). Materials & methods: Eighty-four patients with laBCC received cemiplimab 350 mg every 3 weeks (up to 9 cycles). HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and each cycle. Mixed-effects repeated-measures models evaluated change from baseline across cycles. Results: Clinically meaningful improvement or maintenance was reported by 62–90% of patients on QLQ-C30 scales and by approximately 80% on Skindex-16 scales at Cycle 2, with consistent results at Cycle 9 except fatigue. Conclusion: Most cemiplimab-treated patients with laBCC reported improvement or maintenance of HRQoL with low symptom burden except fatigue. Clinical Trial Registration:ClinicalTrials.gov identifier NCT03132636, registered 28 April 2017. Plain Language Summary Locally advanced basal cell carcinoma (laBCC) is a type of skin cancer that has the potential to invade surrounding tissues including bone, cartilage, nerve and muscle. Cemiplimab-rwlc is approved in the US for patients with laBCC following a therapy called hedgehog inhibitor (HHI) treatment or for whom HHIs are not appropriate. In a Phase II clinical trial, intravenous (in the vein) cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with laBCC who progressed on or were intolerant to HHIs. This analysis evaluated health-related quality of life, symptom burden, emotions and functional status in these patients using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires. Baseline scores (scores at the start of the clinical trial) showed moderate to high levels of functioning and low symptom burden that, except for fatigue, were maintained or improved over the course of cemiplimab treatment. These results show that despite the presence of fatigue, health-related quality of life and functional status were maintained with cemiplimab across the study duration. Tweetable Abstract In patients with locally advanced basal cell carcinoma treated with cemiplimab every 3 weeks for nine treatment cycles, health-related quality of life and functional status were maintained despite the presence of fatigue. Article highlights In a Phase II trial, intravenous cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with locally advanced basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors. Since an important component in cancer clinical trials is the measurement of patient-centric outcomes, this analysis evaluated patient-reported health-related quality of life (HRQoL) among participants in the clinical trial. HRQoL was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30), which consists of a global health status/quality of life (GHS/QoL) scale, five functional scales and eight symptom scales; and the Skindex-16, which assesses the impact of skin disease on HRQoL based on symptom, emotional and functional subscales. Mixed-effects repeated-measures models were used to estimate overall least-squares (LS) mean (95% confidence interval [CI]) change from baseline across Cycles 2–9; absolute changes ≥10 points from baseline were considered clinically meaningful. Overall changes from baseline indicated maintenance for QLQ-C30 GHS/QoL, functioning and symptom scales, except for clinically meaningful worsening of fatigue (LS mean change: 12.0; 95% CI: 4.3–19.6). Clinically meaningful improvement or maintenance on QLQ-C30 GHS/QoL, functioning and symptom scales were reported at Cycle 2 by 88%, 69–81% and 62–90% of patients, respectively, with similar proportions at Cycle 6 (∼1 year of treatment) and consistent results at Cycle 9 except for fatigue. On the Skindex-16, overall change showed clinically meaningful improvement on the emotional subscale (LS mean change, -13.8; 95% CI: -21.4 to -6.2), with maintenance on symptom and functional subscales; clinically meaningful improvement or maintenance across all three subscales was reported by approximately 80% of patients at Cycle 2 that was generally maintained at Cycles 6 and 9. These results show that most patients with laBCC treated with cemiplimab reported clinically meaningful improvement or maintenance in GHS/QoL and functioning while maintaining low symptom burden, except for fatigue. [ABSTRACT FROM AUTHOR]

Published
2024
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12. High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma

Author

Rischin, Danny, primary, Hughes, Brett G M, additional, Basset-Séguin, Nicole, additional, Schadendorf, Dirk, additional, Bowyer, Samantha, additional, Trabelsi Messai, Sabiha, additional, Meier, Friedegund, additional, Eigentler, Thomas K, additional, Casado Echarren, Victoria, additional, Stein, Brian, additional, Beylot-Barry, Marie, additional, Dalac, Sophie, additional, Dréno, Brigitte, additional, Migden, Michael R, additional, Hausschild, Axel, additional, Schmults, Chrysalyne D, additional, Lim, Annette M, additional, Yoo, Suk-Young, additional, Paccaly, Anne J, additional, Papachristos, Apostolos, additional, Nguyen, Jenny-Hoa, additional, Okoye, Emmanuel, additional, Seebach, Frank, additional, Booth, Jocelyn, additional, Lowy, Israel, additional, Fury, Matthew G, additional, and Guminski, Alexander, additional

Published
2024
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13. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial

Author

Stratigos, Alexander J, Sekulic, Aleksandar, Peris, Ketty, Bechter, Oliver, Prey, Sorilla, Kaatz, Martin, Lewis, Karl D, Basset-Seguin, Nicole, Chang, Anne Lynn S, Dalle, Stèphane, Orland, Almudena Fernandez, Licitra, Lisa, Robert, Caroline, Ulrich, Claas, Hauschild, Axel, Migden, Michael R, Dummer, Reinhard, Li, Siyu, Yoo, Suk-Young, Mohan, Kosalai, Coates, Ebony, Jankovic, Vladimir, Fiaschi, Nathalie, Okoye, Emmanuel, Bassukas, Ioannis D, Loquai, Carmen, De Giorgi, Vincenzo, Eroglu, Zeynep, Gutzmer, Ralf, Ulrich, Jens, Puig, Susana, Seebach, Frank, Thurston, Gavin, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Bowler, Timothy, and Fury, Matthew G

Published
2021
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15. Health‐related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a phase 2 trial.

Author

Peris, Ketty, Inocencio, Timothy J., Stratigos, Alexander J., Lewis, Karl D., Eroglu, Zeynep, Chang, Anne Lynn S., Ivanescu, Cristina, Sekulic, Aleksandar, Fury, Matthew G., Chen, Chieh‐I, and Quek, Ruben G. W.

Subjects
SYMPTOM burden, BASAL cell carcinoma, CEMIPLIMAB, QUALITY of life, DISEASE progression
Abstract

Background: A phase 2 cemiplimab study (NCT03132636) demonstrated a 24.1% objective response rate in patients diagnosed with metastatic basal cell carcinoma (mBCC) who were not candidates for continued hedgehog inhibitor (HHI) therapy due to intolerance to previous HHI therapy, disease progression while receiving HHI therapy, or having not better than stable disease on HHI therapy after 9 months. Here, health‐related quality of life (QoL) for this patient population is reported. Methods: Adult patients with mBCC were treated with intravenous cemiplimab at a dose of 350 mg every 3 weeks for 5 treatment cycles of 9 weeks/cycle then 4 treatment cycles of 12 weeks/cycle. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life‐Core 30 (QLQ‐C30) and Skindex‐16 questionnaires at baseline and Day 1 of each cycle. Across Cycles 2 to 9, the overall change from baseline was analyzed using a mixed model with repeated measures. Responder analyses determined clinically meaningful improvement or deterioration (changes ≥10 points) or maintenance across all scales. Results: Patients reported low symptom burden and moderate‐to‐high functioning at baseline. Maintenance for QLQ‐C30 global health status (GHS)/QoL and across all functioning and symptom scales was indicated by overall mean changes from baseline. Clinically meaningful improvement or maintenance was reported at Cycle 2 for GHS/QoL (77%), functioning scales (77% to 86%), and symptom scales (70% to 93%), with similar proportions of improvement or maintenance at Cycles 6 and 9, excluding fatigue. On the Skindex‐16, clinically meaningful improvement or maintenance was reported across the emotional, symptom, and functional subscales, in 76%–88% of patients at Cycle 2, which were generally maintained at Cycles 6 and 9. Overall mean changes from baseline showed maintenance across these subscales. Conclusions: The majority of patients treated with cemiplimab reported improvement or maintenance in GHS/QoL and functioning while maintaining a low symptom burden. [ABSTRACT FROM AUTHOR]

Published
2024
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16. PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer

Author

Rischin, Danny, Gil-Martin, Marta, González-Martin, Antonio, Braña, Irene, Hou, June Y., Cho, Daniel, Falchook, Gerald S., Formenti, Silvia, Jabbour, Salma, Moore, Kathleen, Naing, Aung, Papadopoulos, Kyriakos P., Baranda, Joaquina, Fury, Wen, Feng, Minjie, Stankevich, Elizabeth, Li, Jingjin, Yama-Dang, N. Alice, Yoo, Suk-Young, Lowy, Israel, Mathias, Melissa, and Fury, Matthew G.

Published
2020
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18. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial

Author

Migden, Michael R, Khushalani, Nikhil I, Chang, Anne Lynn S, Lewis, Karl D, Schmults, Chrysalyne D, Hernandez-Aya, Leonel, Meier, Friedegund, Schadendorf, Dirk, Guminski, Alexander, Hauschild, Axel, Wong, Deborah J, Daniels, Gregory A, Berking, Carola, Jankovic, Vladimir, Stankevich, Elizabeth, Booth, Jocelyn, Li, Siyu, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Fury, Matthew G, and Rischin, Danny

Published
2020
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19. Survival With Cemiplimab in Recurrent Cervical Cancer

Author

Tewari, Krishnansu S., Monk, Bradley J., Vergote, Ignace, Miller, Austin, de Melo, Andreia C., Kim, Hee-Seung, Kim, Yong Man, Lisyanskaya, Alla, Samouëlian, Vanessa, Lorusso, Domenica, Damian, Fernanda, Chang, Chih-Long, Gotovkin, Evgeniy A., Takahashi, Shunji, Ramone, Daniella, Pikiel, Joanna, Maćkowiak-Matejczyk, Beata, Alía, Eva M. Guerra, Colombo, Nicoletta, Makarova, Yulia, Rischin, Danny, Lheureux, Stephanie, Hasegawa, Kosei, Fujiwara, Keiichi, Li, Jingjin, Jamil, Shaheda, Jankovic, Vladimir, Chen, Chieh-I, Seebach, Frank, Weinreich, David M., Yancopoulos, George D., Lowy, Israel, Mathias, Melissa, Fury, Matthew G., and Oaknin, Ana

Published
2022
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20. Health-Related Quality of Life in Patients with Metastatic Basal Cell Carcinoma Treated with Cemiplimab: Analysis of a Phase 2 Open-Label Clinical Trial

Author

Lewis, Karl D, primary, Inocencio, Timothy J, additional, Quek, Ruben GW, additional, LaFontaine, Patrick R, additional, Eroglu, Zeynep, additional, Chang, Anne Lynn S, additional, Ivanescu, Cristina, additional, Stratigos, Alexander J, additional, Peris, Ketty, additional, Sekulic, Aleksandar, additional, Fury, Matthew G, additional, and Chen, Chieh-I, additional

Published
2024
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22. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up

Author

Stratigos, Alexander J., primary, Sekulic, Aleksandar, additional, Peris, Ketty, additional, Bechter, Oliver, additional, Prey, Sorilla, additional, Lewis, Karl D., additional, Basset-Seguin, Nicole, additional, Chang, Anne Lynn S., additional, Dalle, Stéphane, additional, Fernandez Orland, Almudena, additional, Licitra, Lisa, additional, Robert, Caroline, additional, Ulrich, Claas, additional, Hauschild, Axel, additional, Migden, Michael R., additional, Dummer, Reinhard, additional, Yoo, Suk-Young, additional, Okoye, Emmanuel, additional, Bassukas, Ioannis, additional, Loquai, Carmen, additional, De Giorgi, Vincenzo, additional, Eroglu, Zeynep, additional, Gutzmer, Ralf, additional, Ulrich, Jens, additional, Puig, Susana, additional, Inocencio, Timothy J., additional, Chen, Chieh-I, additional, LaFontaine, Patrick R., additional, Seebach, Frank, additional, Lowy, Israel, additional, and Fury, Matthew G., additional

Published
2023
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24. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up

Author

Stratigos, Alexander J., Sekulic, Aleksandar, Peris, Ketty, Bechter, Oliver, Prey, Sorilla, Lewis, Karl D., Basset-Seguin, Nicole, Chang, Anne Lynn S., Dalle, Stéphane, Fernández Orland, Almudena, Licitra, Lisa, Robert, Caroline, Ulrich, Claas, Hauschild, Axel, Migden, Michael R., Dummer, Reinhard, Yoo, Suk-Young, Okoye, Emmanuel, Bassukas, Ioannis, Loquai, Carmen, De Giorgi, Vincenzo, Eroglu, Zeynep, Gutzmer, Ralf, Ulrich, Jens, Puig, Susana, Inocencio, Timothy J., Chen, Chieh-I, LaFontaine, Patrick R., Seebach, Frank, Lowy, Israel, and Fury, Matthew G.

Published
2024
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25. Supplementary Figure Legends from The PARP Inhibitor Veliparib Can Be Safely Added to Bendamustine and Rituximab and Has Preliminary Evidence of Activity in B-Cell Lymphoma

Author

Soumerai, Jacob D., primary, Zelenetz, Andrew D., primary, Moskowitz, Craig H., primary, Palomba, M. Lia, primary, Hamlin, Paul A., primary, Noy, Ariela, primary, Straus, David J., primary, Moskowitz, Alison J., primary, Younes, Anas, primary, Matasar, Matthew J., primary, Horwitz, Steven M., primary, Portlock, Carol S., primary, Konner, Jason A., primary, Gounder, Mrinal M., primary, Hyman, David M., primary, Voss, Martin H., primary, Fury, Matthew G., primary, Gajria, Devika, primary, Carvajal, Richard D., primary, Ho, Alan L., primary, Beumer, Jan H., primary, Kiesel, Brian, primary, Zhang, Zhigang, primary, Chen, Alice, primary, Little, Richard F., primary, Jarjies, Christine, primary, Dang, Thu O., primary, France, Fallon, primary, Mishra, Nishant, primary, and Gerecitano, John F., primary

Published
2023
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26. Supplementary Data from First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies

Author

Papadopoulos, Kyriakos P., primary, Johnson, Melissa L., primary, Lockhart, Albert C., primary, Moore, Kathleen, primary, Falchook, Gerald S., primary, Formenti, Silvia C., primary, Naing, Aung, primary, Carvajal, Richard D., primary, Rosen, Lee S., primary, Weiss, Glen J., primary, Leidner, Rom S., primary, Li, Jingjin, primary, Paccaly, Anne, primary, Feng, Minjie, primary, Stankevich, Elizabeth, primary, Lowy, Israel, primary, Fury, Matthew G., primary, and Crittenden, Marka R., primary

Published
2023
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27. Supplementary Figure S1 from The PARP Inhibitor Veliparib Can Be Safely Added to Bendamustine and Rituximab and Has Preliminary Evidence of Activity in B-Cell Lymphoma

Author

Soumerai, Jacob D., primary, Zelenetz, Andrew D., primary, Moskowitz, Craig H., primary, Palomba, M. Lia, primary, Hamlin, Paul A., primary, Noy, Ariela, primary, Straus, David J., primary, Moskowitz, Alison J., primary, Younes, Anas, primary, Matasar, Matthew J., primary, Horwitz, Steven M., primary, Portlock, Carol S., primary, Konner, Jason A., primary, Gounder, Mrinal M., primary, Hyman, David M., primary, Voss, Martin H., primary, Fury, Matthew G., primary, Gajria, Devika, primary, Carvajal, Richard D., primary, Ho, Alan L., primary, Beumer, Jan H., primary, Kiesel, Brian, primary, Zhang, Zhigang, primary, Chen, Alice, primary, Little, Richard F., primary, Jarjies, Christine, primary, Dang, Thu O., primary, France, Fallon, primary, Mishra, Nishant, primary, and Gerecitano, John F., primary

Published
2023
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28. Phase 2 study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Long-term follow-up

Author

Stratigos, Alexander J, primary, Sekulic, Aleksandar, additional, Peris, Ketty, additional, Bechter, Oliver, additional, Prey, Sorilla, additional, Kaatz, Martin, additional, Lewis, Karl D, additional, Basset-Seguin, Nicole, additional, Chang, Anne Lynn S, additional, Dalle, Stéphane, additional, Orland, Almudena Fernandez, additional, Licitra, Lisa, additional, Robert, Caroline, additional, Ulrich, Claas, additional, Hauschild, Axel, additional, Migden, Michael R, additional, Dummer, Reinhard, additional, Yoo, Suk-Young, additional, Coates, Ebony, additional, Okoye, Emmanuel, additional, Bassukas, Ioannis, additional, Loquai, Carmen, additional, De Giorgi, Vincenzo, additional, Eroglu, Zeynep, additional, Gutzmer, Ralf, additional, Ulrich, Jens, additional, Puig, Susana, additional, Seebach, Frank, additional, Lowy, Israel, additional, and Fury, Matthew G, additional

Published
2023
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29. Primary analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors

Author

Lewis, Karl D, primary, Peris, Ketty, additional, Sekulic, Aleksandar, additional, Stratigos, Alexander J, additional, Dunn, Lara, additional, Eroglu, Zeynep, additional, Chang, Anne Lynn S, additional, Migden, Michael R, additional, Yoo, Suk-Young, additional, Mohan, Kosalai, additional, Coates, Ebony, additional, Okoye, Emmanuel, additional, Baurain, Jean-François, additional, Bechter, Oliver, additional, Hauscild, Axel, additional, Butler, Marcus O, additional, Hernandez-Aya, Leonel, additional, Licitra, Lisa, additional, Neves, Rogerio I, additional, Ruiz, Emily S, additional, Seebach, Frank, additional, Lowy, Israel, additional, Goncalves, Priscila, additional, and Fury, Matthew G, additional

Published
2023
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30. A phase 1/2 study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti–PD-1) in patients with advanced solid tumors: Trial-in-progress update.

Author

Segal, Neil Howard, primary, Pelster, Meredith, additional, Girda, Eugenia, additional, Fong, Lawrence, additional, Olszanski, Anthony J., additional, Han, Hyunsil, additional, Casey, Kerry A., additional, Li, Siyu, additional, Welf, Erik, additional, Chen, Chieh-I, additional, Skokos, Dimitris, additional, Seebach, Frank A., additional, Lowy, Israel, additional, Fury, Matthew G., additional, Mathias, Melissa Divya, additional, and Lakhani, Nehal J., additional

Published
2023
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32. A phase 1b dose expansion study of the pan-class I PI3K inhibitor buparlisib (BKM120) plus carboplatin and paclitaxel in PTEN deficient tumors and with dose intensified carboplatin and paclitaxel

Author

Smyth, Lillian M., Monson, Kelsey R., Jhaveri, Komal, Drilon, Alexander, Li, Bob T., Abida, Wassim, Iyer, Gopa, Gerecitano, John F., Gounder, Mrinal, Harding, James J., Voss, Martin H., Makker, Vicky, Ho, Alan L., Razavi, Pedram, Iasonos, Alexia, Bialer, Philip, Lacouture, Mario E., Teitcher, Jerrold B., Erinjeri, Joseph P., Katabi, Nora, Fury, Matthew G., and Hyman, David M.

Published
2017
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33. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma

Author

Gross, Neil D., primary, Miller, David M., additional, Khushalani, Nikhil I., additional, Divi, Vasu, additional, Ruiz, Emily S., additional, Lipson, Evan J., additional, Meier, Friedegund, additional, Su, Yungpo B., additional, Swiecicki, Paul L., additional, Atlas, Jennifer, additional, Geiger, Jessica L., additional, Hauschild, Axel, additional, Choe, Jennifer H., additional, Hughes, Brett G.M., additional, Schadendorf, Dirk, additional, Patel, Vishal A., additional, Homsi, Jade, additional, Taube, Janis M., additional, Lim, Annette M., additional, Ferrarotto, Renata, additional, Kaufman, Howard L., additional, Seebach, Frank, additional, Lowy, Israel, additional, Yoo, Suk-Young, additional, Mathias, Melissa, additional, Fenech, Keilah, additional, Han, Hyunsil, additional, Fury, Matthew G., additional, and Rischin, Danny, additional

Published
2022
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34. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer

Author

Oaknin, Ana, primary, Monk, Bradley J., additional, Vergote, Ignace, additional, Cristina de Melo, Andreia, additional, Kim, Yong-Man, additional, Lisyanskaya, Alla S., additional, Samouëlian, Vanessa, additional, Kim, Hee Seung, additional, Gotovkin, Evgeniy A., additional, Damian, Fernanda, additional, Chang, Chih-Long, additional, Takahashi, Shunji, additional, Li, Jingjin, additional, Mathias, Melissa, additional, Fury, Matthew G., additional, Ivanescu, Cristina, additional, Reaney, Matthew, additional, LaFontaine, Patrick R., additional, Lowy, Israel, additional, Harnett, James, additional, Chen, Chieh-I, additional, and Tewari, Krishnansu S., additional

Published
2022
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38. Abstract CT165: Primary analysis of phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors

Author

Lewis, Karl, primary, Peris, Ketty, additional, Sekulic, Aleksander, additional, Stratigos, Alexander J., additional, Dunn, Lara, additional, Eroglu, Zeynep, additional, Chang, Anne Lynn S., additional, Migden, Michael R., additional, Yoo, Suk-Young, additional, Mohan, Kosalai, additional, Coates, Ebony, additional, Okoye, Emmanuel, additional, Bowler, Timothy, additional, Baurain, Jean-François, additional, Bechter, Oliver, additional, Hauschild, Axel, additional, Butler, Marcus O., additional, Hernandez-Aya, Leonel, additional, Licitra, Lisa, additional, Neves, Rogerio I., additional, Ruiz, Emily S., additional, Seebach, Frank, additional, Weinreich, David M., additional, Yancopoulos, George D., additional, Lowy, Israel, additional, Goncalves, Priscila, additional, and Fury, Matthew G., additional

Published
2022
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39. C-POST protocol update: A phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC).

Author

Rischin, Danny, primary, Brungs, Daniel, additional, Day, Fiona, additional, Christie, Hayden Robert, additional, Patel, Vishal A., additional, Adams, Gerard, additional, Jackson, James Estes, additional, Schurmann, Maite De Liz Vassen, additional, Kirtbaya, Dmitry, additional, Shin, Thuzar M., additional, Hart, Christopher David, additional, Stankevich, Elizabeth, additional, Li, Siyu, additional, Lowy, Israel, additional, Han, Hyunsil, additional, Fury, Matthew G., additional, and Porceddu, Sandro, additional

Published
2022
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40. A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS).

Author

Haydon, Andrew Mark, primary, Khushalani, Nikhil I., additional, Robert, Caroline, additional, Brungs, Daniel, additional, Collichio, Frances A., additional, Colevas, A. Dimitrios, additional, Lim, Annette May Ling, additional, Kudchadkar, Ragini Reiney, additional, Chai-Ho, Wanxing, additional, Daniels, Gregory A., additional, Lutzky, Jose, additional, Lee, Jenny HJ, additional, Silk, Ann W., additional, Lebbe, Celeste, additional, Grob, Jean-Jacques, additional, Smith, Margaret, additional, Fury, Matthew G., additional, Alamgeer, Muhammad, additional, Hill, Andrew Graham, additional, and Migden, Michael Robert, additional

Published
2022
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42. Survival with Cemiplimab in Recurrent Cervical Cancer

Author

Tewari, K, Monk, B, Vergote, I, Miller, A, de Melo, A, Kim, H, Kim, Y, Lisyanskaya, A, Samouëlian, V, Lorusso, D, Damian, F, Chang, C, Gotovkin, E, Takahashi, S, Ramone, D, Pikiel, J, Maćkowiak-Matejczyk, B, Guerra Alía, E, Colombo, N, Makarova, Y, Rischin, D, Lheureux, S, Hasegawa, K, Fujiwara, K, Li, J, Jamil, S, Jankovic, V, Chen, C, Seebach, F, Weinreich, D, Yancopoulos, G, Lowy, I, Mathias, M, Fury, M, Oaknin, A, Tewari, Krishnansu S, Monk, Bradley J, Vergote, Ignace, Miller, Austin, de Melo, Andreia C, Kim, Hee-Seung, Kim, Yong Man, Lisyanskaya, Alla, Samouëlian, Vanessa, Lorusso, Domenica, Damian, Fernanda, Chang, Chih-Long, Gotovkin, Evgeniy A, Takahashi, Shunji, Ramone, Daniella, Pikiel, Joanna, Maćkowiak-Matejczyk, Beata, Guerra Alía, Eva M, Colombo, Nicoletta, Makarova, Yulia, Rischin, Danny, Lheureux, Stephanie, Hasegawa, Kosei, Fujiwara, Keiichi, Li, Jingjin, Jamil, Shaheda, Jankovic, Vladimir, Chen, Chieh-I, Seebach, Frank, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Mathias, Melissa, Fury, Matthew G, Oaknin, Ana, Tewari, K, Monk, B, Vergote, I, Miller, A, de Melo, A, Kim, H, Kim, Y, Lisyanskaya, A, Samouëlian, V, Lorusso, D, Damian, F, Chang, C, Gotovkin, E, Takahashi, S, Ramone, D, Pikiel, J, Maćkowiak-Matejczyk, B, Guerra Alía, E, Colombo, N, Makarova, Y, Rischin, D, Lheureux, S, Hasegawa, K, Fujiwara, K, Li, J, Jamil, S, Jankovic, V, Chen, C, Seebach, F, Weinreich, D, Yancopoulos, G, Lowy, I, Mathias, M, Fury, M, Oaknin, A, Tewari, Krishnansu S, Monk, Bradley J, Vergote, Ignace, Miller, Austin, de Melo, Andreia C, Kim, Hee-Seung, Kim, Yong Man, Lisyanskaya, Alla, Samouëlian, Vanessa, Lorusso, Domenica, Damian, Fernanda, Chang, Chih-Long, Gotovkin, Evgeniy A, Takahashi, Shunji, Ramone, Daniella, Pikiel, Joanna, Maćkowiak-Matejczyk, Beata, Guerra Alía, Eva M, Colombo, Nicoletta, Makarova, Yulia, Rischin, Danny, Lheureux, Stephanie, Hasegawa, Kosei, Fujiwara, Keiichi, Li, Jingjin, Jamil, Shaheda, Jankovic, Vladimir, Chen, Chieh-I, Seebach, Frank, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Mathias, Melissa, Fury, Matthew G, and Oaknin, Ana

Abstract

Background: Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population. Methods: In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed. Results: A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001). The overall survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma and adenocarcinoma [including adenosquamous carcinoma]). Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group in the overall population (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P<0.001). In the overall population, an objective response occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group. An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%. Overall, grade 3 or higher adverse events occurred in 45.0% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy. Conclusions: Survival was significa

Published
2022

44. Parallel phase Ib studies of two schedules of buparlisib (BKM120) plus carboplatin and paclitaxel (q21 days or q28 days) for patients with advanced solid tumors

Author

Hyman, David M., Snyder, Alexandra E., Carvajal, Richard D., Gerecitano, John F., Voss, Martin H., Ho, Alan L., Konner, Jason, Winkelmann, Jennifer L., Stasi, Megan A., Monson, Kelsey R., Iasonos, Alexia, Spriggs, David R., Bialer, Philip, Lacouture, Mario E., Teitcher, Jerrold B., Katabi, Nora, and Fury, Matthew G.

Published
2015
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47. Intensity-Modulated Radiation Therapy in Oropharyngeal Carcinoma: Effect of Tumor Volume on Clinical Outcomes

Author

Lok, Benjamin H., Setton, Jeremy, Caria, Nicola, Romanyshyn, Jonathan, Wolden, Suzanne L., Zelefsky, Michael J., Park, Jeffery, Rowan, Nicholas, Sherman, Eric J., Fury, Matthew G., Ho, Alan, Pfister, David G., Wong, Richard J., Shah, Jatin P., Kraus, Dennis H., Zhang, Zhigang, Schupak, Karen D., Gelblum, Daphna Y., Rao, Shyam D., and Lee, Nancy Y.

Published
2012
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49. Intensity-Modulated Radiotherapy in the Treatment of Oropharyngeal Cancer: An Update of the Memorial Sloan-Kettering Cancer Center Experience

Author

Setton, Jeremy, Caria, Nicola, Romanyshyn, Jonathan, Koutcher, Lawrence, Wolden, Suzanne L., Zelefsky, Michael J., Rowan, Nicholas, Sherman, Eric J., Fury, Matthew G., Pfister, David G., Wong, Richard J., Shah, Jatin P., Kraus, Dennis H., Shi, Weiji, Zhang, Zhigang, Schupak, Karen D., Gelblum, Daphna Y., Rao, Shyam D., and Lee, Nancy Y.

Published
2012
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