RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.

Shen, Lin; Kato, Ken; Kim, Sung‐Bae; Ajani, Jaffer A.; Zhao, Kuaile; Zhou, He; Yu, Xin; Shu, Yongqian; Luo, Qi; Wang, Jufeng; Chen, Zhendong; Niu, Zuoxing; Sun, Jong Mu; Lin, Chen‐Yuan; Pazo‐Cid, Roberto; Borg, Christophe; Li, Liyun; Tao, Aiyang; Cutsem, Éric Van

doi:10.1200/jco.2021.39.15_suppl.4012

Cited by 45 publications

(50 citation statements)

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“…In PD-L1+ patients who received tislelizumab, the median overall survival was 10.3 months vs. 6.8 months for those who received chemotherapy (HR 0.54, 95% CI: 0.36–0.79, P = 0.0006). 109 …”

Section: Antibody Therapeutics Undergoing First Regulatory Review In the Us Or Eumentioning

confidence: 99%

Antibodies to watch in 2022

Kaplon

Chenoweth

Crescioli

et al. 2022

mAbs

290

170

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In this 13th annual installment of the annual ‘Antibodies to Watch’ article series, we discuss key events in commercial antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. Regulatory review of antibody therapeutics that target the SARS-CoV-2 coronavirus proceeded at an unprecedented pace in 2021, resulting in both emergency use authorizations and full approvals for sotrovimab, regdanvimab, REGEN-COV2, as well as others, in numerous countries. As of November 1, a total of 11 antibody therapeutics had been granted first approvals in either the United States or European Union in 2021 (evinacumab, dostarlimab loncastuximab tesirine, amivantamab, aducanumab, tralokinumab, anifrolumab, bimekizumab, tisotumab vedotin, regdanvimab, REGEN-COV2). The first global approvals of seven products, however, were granted elsewhere, including Japan (pabinafusp alfa), China (disitamab vedotin, penpulimab, zimberelimab), Australia (sotrovimab, REGEN-COV2), or the Republic of Korea (regdanvimab). Globally, at least 27 novel antibody therapeutics are undergoing review by regulatory agencies. First actions by the Food and Drug Administration on the biologics license applications for faricimab, sutimlimab, tebentafusp, relatlimab, sintilimab, ublituximab and tezepelumab are expected in the first quarter of 2022. Finally, our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline of antibody therapeutics grew by over 30% in the past year. Of those in late-stage development, marketing applications for at least 22 may occur by the end of 2022.

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Section: Antibody Therapeutics Undergoing First Regulatory Review In the Us Or Eumentioning

confidence: 99%

Antibodies to watch in 2022

Kaplon

Chenoweth

Crescioli

et al. 2022

mAbs

290

170

View full text Add to dashboard Cite

show abstract

“…The RATIONALE 302 trial investigated tislelizumab versus chemotherapy as secondline treatment and found that tislelizumab clinically and significantly improves the OS (median OS: 8.6 versus 6.3 months; HR 0.70; 95% CI 0.57-0.85, p = 0.0001) [46]. These promising novel drugs underline the potential of further investigation of immunotherapeutic agents.…”

Section: Esophageal Squamous Cell Carcinomamentioning

confidence: 99%

Immunotherapy for Esophageal Cancers: What Is Practice Changing in 2021?

Puhr

Preusser

2021

Cancers

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The prognosis of advanced esophageal cancer is dismal, and treatment options are limited. Since the first promising data on second-line treatment with checkpoint inhibitors in esophageal cancer patients were published, immunotherapy was surmised to change the face of modern cancer treatment. Recently, several studies have found this to be true, as the checkpoint inhibitors nivolumab and pembrolizumab have achieved revolutionary response rates in advanced as well as resectable settings in esophageal cancer patients. Although the current results of large clinical trials promise high efficacy with tolerable toxicity, desirable survival rates, and sustained quality of life, some concerns remain. This review aims to summarize the novel clinical data on immunotherapeutic agents for esophageal cancer and provide a critical view of potential restrictions for the implementation of these therapies for unselected patient populations.

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“…Another notable study in the second-line setting is RATIONALE 302, which was recently presented at ASCO 2021 [ 39 ]. In this global, phase 3 study, patients with esoSCC who had advanced/unresectable or metastatic disease and progression after first-line systemic chemotherapy were randomized to receive either tislelizumab (200 mg IV every 3 weeks) or investigator-chosen chemotherapy.…”

Section: The Use Of Ici In the Second-line Settingmentioning

confidence: 99%

“…Results for CPS < 10 tumors were not shown. Survival benefit was consistently observed across pre-defined subgroups and regions [ 39 ].…”

Section: The Use Of Ici In the Second-line Settingmentioning

confidence: 99%

Immune-Checkpoint Inhibition in the Treatment of Gastro-Esophageal Cancer: A Closer Look at the Emerging Evidence

Paydary

Reizine

Catenacci

2021

Cancers

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To date, several trials have evaluated the safety and efficacy of immune-checkpoint inhibitors (ICI) for the treatment of gastroesophageal cancers (GEC). In the US, ICIs have established indications for second-line treatment of microsatellite unstable tumors, while their use in third-line settings was recently withdrawn. Notably, the use of ICIs for first-line therapy of GEC is rapidly evolving, which currently includes high PD-L1 expressing tumors, irrespective of HER2 status, and in the adjuvant setting after neoadjuvant chemoradiotherapy in select patients. In this article, we review the results of studies that have evaluated the utility of ICI in the third-line, second-line, first-line, and peri-operative treatment settings of GECs. Considerations should be made before making any cross-trial comparisons since these trials vary in chemotherapy backbone, anatomical and histological eligibility, biomarker assessment, PD-L1 diagnostic antibodies, and definition of PD-L1 positivity. Regardless, the totality of the data suggest that first-line ICI use may most benefit GEC patients with high PD-L1 combined positivity score (CPS) ≥5 or ≥10, irrespective of histology or anatomy. Moreover, although PD-L1 by CPS has a good negative predictive value for significant benefit from ICIs, it has a low positive predictive value. Therefore, there is a pressing need to identify better biomarkers to predict benefit from ICIs among these patients.

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RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.

Cited by 45 publications

References 0 publications

Antibodies to watch in 2022

Antibodies to watch in 2022

Immunotherapy for Esophageal Cancers: What Is Practice Changing in 2021?

Immune-Checkpoint Inhibition in the Treatment of Gastro-Esophageal Cancer: A Closer Look at the Emerging Evidence

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