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438 | ORELABRUTINIB FOR THE TREATMENT OF RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA: EFFICACY AND SAFETY RESULTS FROM A GLOBAL PHASE 1/2 STUDY
Wang, Y., D’Olimpio, James, Anz, Bertrand, Kryachok, Irina, Gallinson, David, Nogaieva, L., Morrison, David G., Chaudhry, A., Gabrail, N., Muñoz, Judith Peñafiel, Hou, J. , Amin, Bijal , Seneviratne, Lasika, Levi, I., Rekhtman, Grigoriy, Lukavetskyy, Les M., Kio, Ebenezer A., Dunder, Steven, Gardner, F., Huynh, Carissa A., Ursol, G., Popovych, Yuriy, Dreisbach, Luke, Hashmi, Mehmood, Yu, Lei , Zhao, Rui , Wang, Yucai , Flinn, Ian W. , Morrison, D., Munoz, J., Amin, B., Huynh, C., Preis, Meir , Ursol, Grygoriy, Popovych, Y., Zhao, R., Wang, M.
Hematological Oncology | June 16, 2025 | Volume: 43 | Issue: S3 | Pages: No page available
Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma
Wang, Michael , Song, Yuqin, Jurczak, Wojciech, Kahl, Brad S. , Chu, Michael P., Kryachok, Iryna, Fogliatto, Laura, Cheah, Chan Y. , Morawska, Marta , Li, Yufu, Patti, Caterina , Forsyth, Cecily , Lesley, Robin, Ramadan, Safaa, Rule, Simon, Dreyling, Martin , investigators, for the ECHO, Cazap, Nicolás, Foncuberta, María Cecilia, Garate, Gonzalo, Gustavo, Jarchum, Pavlovsky, Miguel Arturo , Riveros, Dardo, Baker, Ross, Butler, Jason, Cannell, Paul , Cheah, Chan, Forsyth, Cecily, Giri, Pratyush, Johnston, Amanda, Lee, Denise , Lee, Hui‐Peng, Mapp, Sally, Roncolato, Fernando , Thant, Aung , Walker, Patricia, Doo, Nicole Wong, Demuynck, Hilde, Offner, Fritz , Hende, Vanessa Van, Vergote, Vibeke, Wu, Ka Lung , Chiattone, Carlos, Azevedo, Sergio de, Fogliatto, Laura, Fonseca, Ana, Hamerschlak, Nelson, Lazaretti, Nicolas, Rocha, Vanderson, Salvino, Marco, Santucci, Rodrigo, Schaan, Mariza, Scheliga, Adriana, Vieira, Garles Miller, Berinstein, Neil, Boutin, Mélina , Chu, Michael, Keating, Mary‐Margaret, Schattner, Ariah, Restrepo, Diego Villa, Cen, Xinan, Du, Xin, Feng, Ru, Gao, Sujun, Huang, Haiwen, Ji, Jie, Jin, Jie, Ke, Xiaoyan, Li, Dengju, Li, Fei, Li, Jianyong, Li, Junmin, Li, Yan, Li, Yufu, Li, Zhenyu, Lin, Li'e, Liu, Tingbo, Lv, Fangfang , Shuang, Yuerong, Sun, Lan, Sun, Xiuhua, Wang, Zhao, Wu, Huijing, Xi, Yaming, Xia, Ruixiang, Xue, Hongwei, Yang, Haiyan, Yi, Shuhua, Zhang, Cheng, Zhang, Huilai, Zhang, Mingzhi, Zhang, Qingyuan, Zhao, Xielan, Zhou, Hui, Hajek, Roman, Jindra, Pavel , Mayer, Jiri, Novak, Jan, Abraham, Julie, Bijou, Fontanet, Bouabdallah, Kamal , Cymbalista, Florence, Guilbert, Sophie, Laribi, Kamel, Rodon, Philippe, Decker, Thomas, Dreger, Peter, Dreyling, Martin, Hess, Georg, Lenz, Georg, Stilgenbauer, Stephan, Tummes, Dirk, Anargyrou, Konstantinos , Dimopoulos, Meletios-Athanassios, Kapsali, Eleni, Kyriakou, Despoina, Panayiotidis, Panayiotis, Pappa, Vasiliki , Stavroyianni, Niki, Cheng, Hoi Ching, Kwong, Yok-Lam, Lee, Harold, Ng, Ting Ying, Wong, Raymond, Borbényi, Zita , Illés, Árpád, Lázár, Zsolt, Nagy, Ãgnes , Nagy, Zsolt, Schneider, Tamas, Avivi, Irit, Gurion, Ronit, Horowitz, Netanel, Ronson, Aaron, Arcaini, Luca, Boccomini, Carola, Ghia, Paolo, Luminari, Stefano, Plenteda, Caterina, Santoro, Armando, Zilioli, Vittorio Ruggero, Zinzani, Pier Luigi, Choi, Ilseung , Ennishi, Daisuke , Ichikawa, Satoshi, Ishikawa, Takayuki, Izutsu, Koji, Kato, Koji, Maruyama, Dai, Nagai, Hirokazu, Ota, Shuichi, Saito, Toko, Sakai, Rika, Suzuki, Ritsuro, Uoshima, Nobuhiko , Yano, Takahiro, Yoshida, Isao, Eom, Ki-Seong, Kim, Jin Seok, Kim, Seok Jin, Lee, Jung-Hee, Mun, Yeung Chul, Yoon, Sung Soo , Arreguin, Elsa Veronica Avila, Andrade, Adriana Dominguez, Almaguer, David Gómez, Vera, Maria Silvia Rivas, Anaya, Luis Solís, Berkahn, Leanne, Pemberton, Lucy, Simpson, David, Beltrán, Brady, Quintana, Shirely, Revilla, Jose Carlos, Vargas, Ernesto, Grosicki, Sebastian , Hałka, Janusz , Jedrzejczak, Wieslaw, Knopińska-Posłuszny, Wanda, Krzanowski, Jacek, Lech-Maranda, Ewa, Robak, Tadeusz, Rzepecki, Piotr , Wróbel, Tomasz, Borsaru, Gabriela, Ciuleanu, Tudor Eliade, Danaı̈la, Catalin, Lazaroiu, Mihaela, Alexeeva, Julia, Chistyakov, Valeriy, Manikhas, Georgy, Mikhailova, Natalia, Proydakov, Andrey, Volodicheva, Elena , Voloshin, Sergey, Bastos, Mariana, Cordoba, Raul, Codina, José , Gonzalez, Eva Maria, Marin, Ana, Panizo, Carlos, Rodriguez, Guillermo, Salar, Antonio, Sancho, Juan-Manuel, Velo, Jose A, Chiu, Chang-Fang, Hsiao, Liang-Tsai, Kuo, Ching-Yuan, Lin, Tung-Liang, Lysa, Tamila, Maslyak, Zvenyslava, Nogaieva, Larysa, Polenkov, Sergey, Usenko, Ganna, Agajanian, Richie, Anz, Bertrand, Chaudhry, Arvind, Chiu, Alden , Cultrera, Jennifer, D’Olimpio, James, Dunleavy, Kieron, Fanning, Suzanne, Flinn, Ian, Gabrail, Nashat, Gallinson, David, Goldenberg, Alec, Graf, Solomon, Grover, N., Hess, Brian, Hoffman, Marc, Isufi, Iris, Kahl, Brad, Kambhampati, Suman , Kirkel, Dean, Diaz, Guillermo Lazo, Levy, Moshe, Liu, Delong, Mead, Monica , Paludo, Jonas, Patel, Anjan, Peles, Shachar, Persky, Daniel, Portell, Craig, Rosenthal, Allison, Sano, Dahlia , Smith, Sonali , Smith, Stephen, Spurgeon, Stephen, Tache, Jason, Tsai, Michaela, Veltri, Lauren, Wang, Michael, Yimer, Habte, Bach, Quoc Khanh, Đỗ, Huyền Nga, Luu, Hung Vu, Khoa, Trọng, Phạm, Như Hiệp, Panizo, Carlos , Kriachok, Iryna , Kahl, Brad S , Paludo, Jonas , Cheah, Chan Yoon , Morawska, Marta , Sancho, Juan-Manuel , Forsyth, Cecily , Dreyling, Martin , Belada, David , Song, Yuqin , Paludo, Jonas , Fogliatto, Laura , Zhang, Jingyang , Lesley, Robin, Ramadan, Safaa Mahmoud , Garate, Gonzalo, Riveros, Dardo Alberto, Cannell, Paul , Cochrane, Tara , Giri, Pratyush, Mapp, Sally , Doo, Nicole Wong , Demuynck, H, Hende, Vanessa Van, Vergote, Vibeke K. 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Journal of Clinical Oncology | May 1, 2025 | Volume: 43 | Issue: 20 | Pages: 2276-2284
PURPOSE The combination of the Bruton tyrosine kinase inhibitor ibrutinib with bendamustine-rituximab for first-line treatment of mantle cell lymphoma (MCL) prolonged progression-free survival (PFS), but without improvement in overall survival (OS), likely because of toxicity. Acalabrutinib was shown to be efficacious and less toxic than ibrutinib in a head-to-head trial in chronic lymphocytic leukemia and therefore might lead to better outcomes in MCL. METHODS Patients 65 years and older with previously untreated MCL received acalabrutinib (100 mg twice daily) or placebo (until disease progression or unacceptable toxicity), plus six cycles of bendamustine (90 mg/m 2 once daily; days 1 and 2) and rituximab (375 mg/m 2 as a single dose; day 1) followed by rituximab maintenance in responding patients for 2 years. Crossover to acalabrutinib at disease progression was permitted. The primary end point was PFS per the independent review committee; overall response rate and OS were secondary end points. RESULTS In total, 598 patients were randomly assigned, with 299 in each arm. At a median follow-up of 49.8 months using the reverse Kaplan-Meier method, the median PFS was 66.4 months in the acalabrutinib arm and 49.6 months in the placebo arm (hazard ratio [HR], 0.73 [95% CI, 0.57 to 0.94]; P = .0160). Benefit was seen across all subgroups, including those with high-risk features. Overall response/complete response rates were 91.0%/66.6% and 88.0%/53.5% in the acalabrutinib and placebo arms, respectively. OS was not significantly different (HR, 0.86 [95% CI, 0.65 to 1.13]; P = .27). Grade 3 or greater adverse events were reported in 88.9% and 88.2% in the acalabrutinib and placebo arms, respectively. CONCLUSION The combination of acalabrutinib with bendamustine-rituximab significantly improved PFS. Clinical benefit of acalabrutinib with bendamustine-rituximab was achieved with manageable toxicity.
P18 Pemigatinib for previously treated locally advanced or metastatic cholangiocarcinoma: final results from FIGHT-202
Sahai, Vaibhav , Vaccaro, Gina M. , Rajabi, Raed MAl, Paulson, Andrew Scott , Gallinson, David, Oh, Do‐Youn , Catenacci, Daniel V.T. , Lihou, Christine , Véronèse, L., Sahai, Vaibhav , Vogel, Arndt , Hollebecque, Antoine , Melisi, Davide , Borad, Mitesh J. , Murphy, Adrian , Dotan, Efrat , Cutsem, Eric Van , Zhen, Huiling, Abou‐Alfa, Ghassan K.
Abstracts | September 20, 2022 | Volume: No volume available | Issue: No issue available | Pages: A44.1-A44
Pemigatinib for previously treated locally advanced/metastatic cholangiocarcinoma (CCA): Update of FIGHT-202.
Sahai, Vaibhav , Vaccaro, Gina M. , Al-Rajabi, Raed Moh’d Taiseer , Paulson, Andrew Scott , Gallinson, David, Oh, Do‐Youn , Catenacci, Daniel V.T. , Lihou, Christine , Féliz, Luis , Sahai, Vaibhav , Abou‐Alfa, Ghassan K. , Hollebecque, Antoine , Melisi, Davide , Borad, Mitesh J. , Murphy, Adrian , Dotan, Efrat , Cutsem, Eric Van , Zhen, Huiling, Vogel, Arndt
Journal of Clinical Oncology | June 2, 2021 | Volume: 39 | Issue: 15_suppl | Pages: 4086-4086
10.1200/jco.2021.39.15_suppl.4086
4086 Background: Pemigatinib (PEMI), a potent, selective, oral FGFR1-3 inhibitor, has shown efficacy and safety in patients (pts) with CCA and FGFR2 rearrangements/fusions in FIGHT-202 (NCT02924376; objective response rate [ORR], 35.5%; duration of response [DOR], 7.2 months [mo]). Overall survival (OS: 21.1 mo) was not mature in the primary report (Abou-Alfa. Lancet Oncol 2020; cutoff: Mar 22, 2019); herein we report matured efficacy and safety data from FIGHT-202 (cutoff: Apr 7, 2020). Methods: Pts (≥18 y) with known FGF/FGFR alterations and progression after ≥1 prior therapy had FGFR2 rearrangements/fusions (cohort A), other FGF/FGFR alterations (B), or no FGF/FGFR alterations (C). Pts received PEMI 13.5 mg QD (21-d cycle; 2 wks on, 1 wk off) until progression or toxicity. Primary endpoint: independent, centrally confirmed ORR (cohort A); secondary endpoints: ORR (cohorts B, C; cohorts A and B combined); DOR, disease control rate (DCR), progression free survival (PFS), OS, and safety. A post-hoc analysis in cohort A evaluated mOS in responders (pts with complete response [CR] or partial response [PR]) vs non-responders (pts with progressive disease [PD] or stable disease (SD]). Results: At cutoff, 147 pts were enrolled (cohort A, n=108; B, n=20; C, n=17; FGF/FGFR status undetermined, n=2); median follow-up was 30.4 (range, 4.9–38.7) mo and median treatment duration was 5.9 (0.2–36.5) mo. In cohort A, 9.3% of pts remained on therapy at cutoff; in cohorts B and C, all pts had discontinued. Pts discontinued mainly for PD (67.6%, 75%, and 64.7% in cohorts A, B, and C respectively). Independent, centrally confirmed ORR was 37.0%; mOS was 17.5 mo (95% CI, 14.4-22.9) in cohort A (Table 1). mOS for responders (n=40) vs non-responders (n=68) was 30.1 (95% CI, 21.5-NE) mo vs 13.7 (9.6-16.1) mo. Overall, most common all-cause treatment-emergent adverse events (TEAEs) were hyperphosphatemia (58.5%; grade ≥3, 0%), alopecia (49.7%; 0%), diarrhea (46.9%; 3.4%), fatigue (43.5%; 5.4%), nausea (41.5%; 2%), and dysgeusia (40.8%; 0%); 10.2%, 13.6% and 42.2% of pts discontinued, had dose reduction, and treatment interruption due to TEAEs, respectively. Conclusions: These results reinforce the primary data, showing continued, durable responses and sustained tolerability in pts receiving PEMI for CCA harboring FGFR2 rearrangements/fusions. Notably, the matured OS is longer than historical data; OS for responders was more than twice as long vs for non-responders. Clinical trial information: NCT02924376. [Table: see text]