Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
Robert J. Motzer,Bernard Escudier,David F. McDermott,Saby George,Hans J. Hammers,Sandhya Srinivas,Scott S. Tykodi,Jeffrey A. Sosman,Giuseppe Procopio,Elizabeth R. Plimack,Daniel Castellano,Toni K. Choueiri,Howard Gurney,Frede Donskov,Petri Bono,John Wagstaff,Thomas Gauler,Takeshi Ueda,Yoshihiko Tomita,Fabio A.B. Schutz,Christian Kollmannsberger,James Larkin,Alain Ravaud,Jason S. Simon,Li-an Xu,Ian M. Waxman,Padmanee Sharma +26 more
TLDR
Overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus among patients with previously treated advanced renal-cell carcinoma.Abstract:
BackgroundNivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment. MethodsA total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety. ResultsThe median overall survival was 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. The haz...read more
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Recurrent SERPINB3 and SERPINB4 mutations in patients who respond to anti-CTLA4 immunotherapy
Nadeem Riaz,Jonathan J. Havel,Sviatoslav M. Kendall,Vladimir Makarov,Logan A. Walsh,Alexis Desrichard,Nils Weinhold,Timothy A. Chan +7 more
TL;DR: It is shown that somatic mutations in SERPINB3 andSERPINB4 are associated with survival after anti-CTLA4 immunotherapy in two independent cohorts of patients with melanoma.
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Predictive factors for hyperprogressive disease during nivolumab as anti-PD1 treatment in patients with advanced gastric cancer
Akinori Sasaki,Yoshiaki Nakamura,Saori Mishima,Akihito Kawazoe,Yasutoshi Kuboki,Hideaki Bando,Takashi Kojima,Toshihiko Doi,Atsushi Ohtsu,Takayuki Yoshino,Takeshi Kuwata,Tetsuo Akimoto,Kohei Shitara +12 more
TL;DR: Hyperprogressive disease was observed in AGC patients treated with nivolumab and correlated with some clinicopathological characteristics and Elevations in ANC and CRP levels upon treatment might indicate HPD.
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Immune‐Related Adverse Events as a Biomarker in Non‐Melanoma Patients Treated with Programmed Cell Death 1 Inhibitors
Julia Judd,Matthew Zibelman,Elizabeth Handorf,John O'Neill,Chethan Ramamurthy,Sasini Bentota,Jamie Doyle,Robert G. Uzzo,Jessica Bauman,Hossein Borghaei,Elizabeth R. Plimack,Ranee Mehra,Daniel M. Geynisman +12 more
TL;DR: Positive associations between the development of irAEs and clinical outcomes in non-melanoma patients treated with PD-1 CKIs are demonstrated, indicating that for a subset of patients, in particular those with low-grade immune-related adverse events, immune- related adverse events predicted for an improved response rate and longer time to next therapy or death.
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Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials
Ricardo Costa,Benedito A. Carneiro,Mark Agulnik,Alfred Rademaker,Sachin Gopalkrishna Pai,Victoria M. Villaflor,Massimo Cristofanilli,Jeffrey A. Sosman,Francis J. Giles +8 more
TL;DR: A meta-analysis of randomized clinical trials found approved PD-1 inhibitors are well tolerated, associated with significant low risk of severe treatment-related AEs and increased risk of thyroid dysfunction, pruritus, and vitiligo.
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Single-cell sequencing links multiregional immune landscapes and tissue-resident T cells in ccRCC to tumor topology and therapy efficacy.
Chirag Krishna,Renzo G. DiNatale,Fengshen Kuo,Raghvendra M. Srivastava,Lynda Vuong,Diego Chowell,Sounak Gupta,Chad M. Vanderbilt,Tanaya A. Purohit,Ming Liu,Emily R. Kansler,Briana G. Nixon,Briana G. Nixon,Ying-Bei Chen,Vladimir Makarov,Kyle A. Blum,Kyrollis Attalla,Stanley Weng,Michael L. Salmans,Mahdi Golkaram,Li Liu,Shile Zhang,Raakhee Vijayaraghavan,Traci Pawlowski,Victor E. Reuter,Maria I. Carlo,Martin H. Voss,Jonathan A. Coleman,Paul Russo,Robert J. Motzer,Ming O. Li,Christina S. Leslie,Timothy A. Chan,A. Ari Hakimi +33 more
TL;DR: In this article, paired single-cell RNA (scRNA) and T-cell receptor (TCR) sequencing of 167,283 cells from multiple tumor regions, lymph node, normal kidney, and peripheral blood of two immune checkpoint blockade (ICB)-naive and four ICB-treated patients to map the ccRCC immune landscape.
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TL;DR: Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level.
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