scholarly journals Randomized, open-label phase 2 study comparing frontline dovitinib versus sorafenib in patients with advanced hepatocellular carcinoma

Hepatology ◽  
2016 ◽  
Vol 64 (3) ◽  
pp. 774-784 ◽  
Author(s):  
Ann-Lii Cheng ◽  
Sumitra Thongprasert ◽  
Ho Yeong Lim ◽  
Wattana Sukeepaisarnjaroen ◽  
Tsai-Shen Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Advanced Hepatocellular Carcinoma ◽  
Phase 2 ◽  
Open Label ◽  
Phase 2 Study ◽  
Open Label Phase

scholarly journals Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression

2021 ◽  
Author(s):  
Baek-Yeol Ryoo ◽  
Ann-Li Cheng ◽  
Zhenggang Ren ◽  
Tae-You Kim ◽  
Hongming Pan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Primary Endpoint ◽  
Objective Response ◽  
Progression Free Survival ◽  
Advanced Hepatocellular Carcinoma ◽  
Phase 2 ◽  
Open Label ◽  
Asian Patients ◽  
Open Label Phase ◽  
Phase 1B

Abstract Background This open-label, Phase 1b/2 study evaluated the highly selective MET inhibitor tepotinib in systemic anticancer treatment (SACT)-naive Asian patients with advanced hepatocellular carcinoma (aHCC) with MET overexpression. Methods In Phase 2b, tepotinib was orally administered once daily (300, 500 or 1,000 mg) to Asian adults with aHCC. The primary endpoints were dose-limiting toxicities (DLTs) and adverse events (AEs). Phase 2 randomised SACT-naive Asian adults with aHCC with MET overexpression to tepotinib (recommended Phase 2 dose [RP2D]) or sorafenib 400 mg twice daily. The primary endpoint was independently assessed time to progression (TTP). Results In Phase 1b (n = 27), no DLTs occurred; the RP2D was 500 mg. In Phase 2 (n = 90, 45 patients per arm), the primary endpoint was met: independently assessed TTP was significantly longer with tepotinib versus sorafenib (median 2.9 versus 1.4 months, HR = 0.42, 90% confidence interval: 0.26–0.70, P = 0.0043). Progression-free survival and objective response also favoured tepotinib. Treatment-related Grade ≥3 AE rates were 28.9% with tepotinib and 45.5% with sorafenib. Conclusions Tepotinib improved TTP versus sorafenib and was generally well tolerated in SACT-naive Asian patients with aHCC with MET overexpression. Trial registration ClinicalTrials.gov NCT01988493.

scholarly journals A Phase 2 Study of Camrelizumab for Advanced Hepatocellular Carcinoma: Two-Year Outcomes and Continued Treatment beyond First RECIST-Defined Progression

Liver Cancer ◽  
2021 ◽  
pp. 1-10
Author(s):  
Zhenggang Ren ◽  
Shukui Qin ◽  
Zhiqiang Meng ◽  
Zhendong Chen ◽  
Xiaoli Chai ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Median Duration ◽  
Evaluation Criteria ◽  
Group Versus ◽  
Advanced Hepatocellular Carcinoma ◽  
Phase 2 ◽  
Open Label ◽  
Durable Response ◽  
Phase 2 Study

<b><i>Introduction:</i></b> In a multicenter, open-label, parallel-group, randomized, phase 2 study for pretreated advanced hepatocellular carcinoma (HCC), camrelizumab showed potent antitumor activity and acceptable safety profile. The aim of this report was to provide long-term data and evaluate potential benefit of treatment with camrelizumab beyond progression. <b><i>Methods:</i></b> From November 15, 2016, to November 16, 2017, 217 patients received camrelizumab 3 mg/kg intravenously every 2 or 3 weeks. Treatment beyond first Response Evaluation Criteria in Solid Tumors (RECIST)-defined progression (TBP) with camrelizumab was allowed. <b><i>Results:</i></b> At data cutoff of December 16, 2019 (&#x3e;2 years after the last patient enrollment; median duration of follow-up, 13.2 months [IQR 5.7–25.8]), 14 (43.8%) of the 32 responses per blinded independent central review were ongoing. The median duration of response was not reached (range 2.5–30.5 + months). The ongoing response rates at 12, 18, and 24 months were 68.3% (95% confidence interval [CI] 47.7–82.2), 59.8% (95% CI 38.8–75.6), and 53.1% (95% CI 31.0–71.0), respectively. The median overall survival (OS) was 14.2 months (95% CI 11.5–16.3). The 18- and 24-month OS rates were 41.3% (95% CI 34.6–47.9) and 33.7% (95% CI 27.3–40.2), respectively. Of the 172 patients who experienced RECIST-defined progression per investigator, 102 received TBP, while 70 did not (non-TBP). The median OS was 16.9 months (95% CI 13.3–22.6) in the TBP group versus 9.4 months (95% CI 5.8–14.8) in the non-TBP group, and the 18- and 24-month OS rates were 47.5% (95% CI 37.3–56.9) versus 33.1% (95% CI 22.3–44.3) and 38.8% (95% CI 29.2–48.4) versus 23.2% (95% CI 13.8–34.1), respectively. No new safety signals of camrelizumab were observed. <b><i>Conclusions:</i></b> With prolonged follow-up, camrelizumab continues to demonstrate the durable response and long survival in pretreated advanced HCC patients with manageable toxicities, especially in those who continued the treatment beyond first RECIST-defined progression.

Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

2020 ◽  
Vol 21 (2) ◽  
pp. 207-221 ◽  
Author(s):  
Sagar Lonial ◽  
Hans C Lee ◽  
Ashraf Badros ◽  
Suzanne Trudel ◽  
Ajay K Nooka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 2 ◽  
Open Label ◽  
Refractory Multiple Myeloma ◽  
Phase 2 Study ◽  
Open Label Phase
Sign in / Sign up

Export Citation Format

Share Document