Author: George, S ; Rha, S Y ; Motzer, R J ; Burgents, J E ; Narita, Y ; Huang, J ; Eto, M ; Hutson, T E ; Winquist, E ; Zhao, Z ; Merchan, J R ; Cristescu, R ; Okpara, C E ; Minoshima, Y ; Grünwald, V ; Markensohn, J ; Porta, C ; Choueiri, T K ; Gurney, H ; Sachdev, P

BACKGROUNDIn CLEAR, lenvatinib + pembrolizumab (L + P) significantly improved efficacy versus sunitinib in first-line treatment of patients with advanced renal cell carcinoma (aRCC). We report results from CLEAR biomarker analyses.PATIENTS AND METHODSProgrammed death-ligand 1 (PD-L1) immunohistochemistry (IHC) and next-generation sequencing assays (whole exome sequencing/RNA sequencing) were carried out on archival tumor specimens. For IHC-derived/RNA sequencing analyses, a continuous analysis was carried out adjusting by Karnofsky performance status (KPS) score for: PD-L1 combined positive score (CPS) versus best overall response (BOR)/progression-free survival (PFS); and each gene signature score [T-cell inflamed gene expression profile (Tcell_infGEP)/non-Tcell_infGEP signatures including proliferation and angiogenesis] versus BOR/PFS. Association between mutation status of RCC driver genes and PFS were analyzed for genes for which ≥20 patients per arm had oncogenic alterations. Association of molecular subtypes with outcome was evaluated with baseline KPS adjustments. The set of biomarkers evaluated and statistical significance criteria for PD-L1 CPS, gene signature scores, and molecular subtypes were prespecified.RESULTSWithin-arm analyses using continuous values showed no association between PD-L1 levels and BOR/PFS for either treatment. PFS hazard ratios between arms were similar regardless of the mutant or wild-type subgroups of RCC driver genes (VHL, PBRM1, SETD2, BAP1, KDM5C). No associations between PFS and gene signature scores were observed for L + P. With sunitinib, high proliferation and MYC signature scores showed shorter PFS; high angiogenesis and microvessel density signature scores showed longer PFS. Six new molecular subtypes were defined. Tumors of patients with favorable/intermediate risk were enriched in angiogenesis and angiogenesis/stromal clusters; those with poor risk were enriched in proliferative and unclassified (low-Tcell_infGEP/low-angiogenesis/low-proliferation) clusters. No association between molecular subtypes and PFS for L + P/sunitinib was observed (after adjustment for KPS and gene signatures that were individually associated with PFS).CONCLUSIONSImprovements in objective response rate and PFS for L + P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes.

28 Mar 2025·Journal of the National Comprehensive Cancer Network

TIP25-243: Randomized Study Evaluating Optimal Dose, Efficacy and Safety of E7386 + Lenvatinib Versus Treatment of Physicians' Choice in Advance/Recurrent Endometrial Carcinoma Previously Treated With Anti-PD-(L)1 Immunotherapy

Article

Author: Eskander, Ramez ; Mirza, Mansoor ; Hu, Tianle ; Makker, Vicky ; Lee, Jung-Yun ; Mackay, Helen ; Corr, Bradley ; Wu, Xiaohua ; Oaknin, Ana ; Lorusso, Domenica ; Okpara, Chinyere ; Ray-Coquard, Isabelle ; McKenzie, Jodi ; Gonzalez-Martin, Antonio ; Hasegawa, Kosei ; Dutta, Lea ; Leary, Alexandra

20 Mar 2025·Journal of Clinical Oncology

First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial

Article

Author: Korach, Jacob ; Orlowski, Robert ; Guedes, João Daniel Cardoso ; Harrison, Michelle ; Graham, Deena M. ; Kaen, Diego Lucas ; Zamora, Liliana Beatriz ; Kryzhanivska, Anna ; Lu, Chien-Hsing ; Lewin, Sharyn ; Santin, Alessandro ; Casado Herraez, Antonio ; Friedlander, Michael ; Stillie, Alison ; Ozerkan, Kemal ; Lv, Weiguo ; Pignata, Sandro ; Lee, Christine ; Guerrero Cabrera, Fernando Felix ; Diaz Redondo, Tamara ; Frentzas, Sophia ; Huang, Yi ; Bollinger, Lauren ; Belonogov, Aleksandr ; Bidziński, Mariusz ; Altintas, Sevilay ; Krasnohrud, Yuliia ; Meniawy, Tarek ; Eminowicz, Gemma ; Jia, Xuemei ; Tarnawski, Rafal ; Zibetti Dal Molin, Graziela ; Danska-Bidzinska, Anna ; Scalici, Jennifer ; Rubio Perez, Maria Jesus ; Cadoo, Karen ; Ethier, Josee-Lyne ; Westhoff, Gina ; Vardar, Mehmet Ali ; Kim, Yong Man ; Villalobos Valencia, Ricardo ; Simsek, Tayup ; Van Gorp, Toon ; Marth, Christian ; Scollo, Paolo ; Escobar Penagos, Jose ; Vasiliev, Aleksandr Gennadievich ; Salutari, Vanda ; de Melo, Andreia Cristina ; Voitko, Nataliia ; Ghamande, Sharad ; Bednarek, Wieslawa ; Nakamura, Kazuto ; Mattar, Andre ; Pan, Lingya ; Kalinka, Ewa ; Hall, Marcia ; Wu, Xiaohua ; Polterauer, Stephan ; Fortin, Suzanne ; Mach, Pawel ; Kedrova, Anna ; Van Le, Linda ; Konecny, Gottfried E. ; Sukhina, Olena ; Beiner, Mario ; Levy, Talia ; Kose, Fatih ; Kaen, Diego ; Rumyantsev, Alexey Alexandrovich ; Blank, Stephanie ; Baurain, Jean-Francois ; Makarycheva, Yulia ; Bessette, Paul ; Kim, Yong Beom ; Shannon, Catherine Margaret ; Makker, Vicky ; Anderson, Charles ; Rykov, Ivan V. ; McKenzie, Jodi ; Damian, Fernanda Bronzon ; Gonzalez Mendoza, Rene Lazaro ; Zhu, Jianqing ; Ellard, Susan ; Zheng, Hong ; Franke, Fabio Andre ; Okpara, Chinyere E. ; Santana, Rosane O. ; Lheureux, Stephanie ; Hughes, Andrew ; Katsumata, Noriyuki ; Kikuchi, Akira ; Kolinsky, Michael ; Magallanes Maciel, Manuel Ernesto ; Nishio, Shin ; Kumar Tyagi, Nidhi ; Kulyaba, Yaroslav ; de Freitas Junior, Ruffo ; Ananda, Sumitra ; Braicu, Elena Ioana ; Bell, Maria ; Ayhan, Ali ; Buscema, Joseph ; Shalkova, Mariia ; MacKay, Helen ; Safina, Sufia Zievna ; Ma, Cailing ; Diakos, Connie ; Samouëlian, Vanessa ; Baron-Hay, Sally ; Wang, Peng-Hui ; Lopez Chuken, Yamil Alonso ; Kim, Sang Wun ; Lisyanskaya, Alla Sergeevna ; Yao, Lili ; Gilbert, Lucy ; Piatnytska, Tetiana ; Braly, Patricia ; Mackowiak-Matejczyk, Beata ; Zamagni, Claudio ; Marmè, Frederik ; Tsunoda, Takuya ; Lin, Wu-Chou ; Svintsitsky, Valentyn ; Gao, Bo ; Kudaka, Wataru ; Magallanes-Maciel, Manuel ; Yao, Shuzhong ; Fehniger, Julia ; Musaeva, Natalia ; Mattar, André ; Amnon, Amit ; Takano, Masashi ; Tinker, Anna ; Bondarenko, Igor ; Hasegawa, Kosei ; Chou, Hung-Hsueh ; Chen, Xiaojun ; Cheng, Wen-Fang ; Sonoda, Kenzo ; Moore, Richard G. ; Casarini, Ignacio Alfredo ; Wu, Yumei ; Naglieri, Emanuele ; Romero Noguera, Ignacio ; Roszak, Andrzej ; Witteler, Ralf ; Romeo Marin, Margarita ; Chekerov, Radoslav ; De Bock, Marlies ; Kobayashi, Yoichi ; Yamagami, Wataru ; An, Ruifang ; Petru, Edgar ; Alfie, Margarita Sonia ; Bidzinski, Mariusz ; Khemka, Vivek ; Yunokawa, Mayu ; Lima, Joao Paulo da Silveira Nogueira ; Zhang, Yu ; Kamiura, Shoji ; Choi, Chel Hun ; Quindos Varela, Maria ; Taus Garcia, Alvaro ; Rubio, M. Jesús ; Lim, Charles ; Corr, Bradley ; Vulsteke, Christof ; Matsumoto, Koji ; Kim, Hee Seung ; Koralewski, Piotr ; Gomez Abuin, Gonzalo ; Horie, Koji ; Khalique, Saira ; Usami, Tomoka ; Urmancheeva, Adiliya Fettekhovna ; Berger, Regina ; Kato, Hidenori ; Suzuki, Nao ; Averina, Hanna ; Zhou, Qi

PURPOSE Lenvatinib plus pembrolizumab (len + pembro) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in previously treated advanced or recurrent endometrial cancer (aEC) in the phase III Study 309/KEYNOTE-775. We report results from the phase III, randomized, open-label European Network of Gynaecological Oncological Trial-en9/LEAP-001 study (ClinicalTrials.gov identifier: NCT03884101 ) that evaluated len + pembro versus chemotherapy in first-line aEC. METHODS Patients with stage III to IV or recurrent, radiographically apparent EC and no previous chemotherapy or disease progression ≥6 months after neo/adjuvant platinum-based chemotherapy were randomly assigned 1:1 to lenvatinib 20 mg once daily plus pembrolizumab 200 mg once every 3 weeks or paclitaxel 175 mg/m 2 plus carboplatin AUC 6 mg/mL/min once every 3 weeks. Primary end points were PFS and OS, evaluated in the mismatch repair-proficient (pMMR) and all-comers populations. Noninferiority was assessed for OS at final analysis (FA) for len + pembro versus chemotherapy (multiplicity-adjusted, one-sided nominal alpha, .0159; null hypothesis–tested hazard ratio [HR], 1.1). RESULTS Eight hundred forty-two patients were randomly assigned (len + pembro, n = 420 [pMMR population, n = 320]; chemotherapy, n = 422 [pMMR population, n = 322]). At FA (data cutoff, October 2, 2023), median PFS (95% CI) in the pMMR population was 9.6 (8.2 to 11.9) versus 10.2 (8.4 to 10.5) months with len + pembro versus chemotherapy (hazard ratio [HR], 0.99 [95% CI, 0.82 to 1.21]) and among all-comers was 12.5 (10.3 to 15.1) versus 10.2 (8.4 to 10.4) months (HR, 0.91 [95% CI, 0.76 to 1.09]; descriptive analyses). Median OS (95% CI) in the pMMR population was 30.9 (25.4 to 37.7) versus 29.4 (26.2 to 35.4) months with len + pembro versus chemotherapy (HR, 1.02 [95% CI, 0.83 to 1.26]; noninferiority P = .246, not statistically significant per multiplicity control strategy) and among all-comers was 37.7 (32.2 to 43.6) versus 32.1 (27.2 to 35.7) months (HR, 0.93 [95% CI, 0.77 to 1.12]). Grade ≥3 treatment-related adverse events occurred in 331/420 (79%) versus 274/411 (67%) treated patients. CONCLUSIONFirst-line len + pembro did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in pMMR aEC.

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