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February 5, 2021

LoA Update: BeiGene’s Phase III tislelizumab for esophageal squamous cell carcinoma sees 10-point jump for FDA approval forecast

As of 29 January, the US likelihood of approval (LoA) for BeiGene’s Phase III anti-PD-1 antibody for esophageal squamous cell carcinoma (ESCC) rose 10 points, according to GlobalData’s LoA data.

By Jennifer Smith-Parker

As of 29 January, the US likelihood of approval (LoA) for BeiGene’s Phase III anti-PD-1 antibody for esophageal squamous cell carcinoma (ESCC) rose 10 points, according to GlobalData’s LoA data. The score change was based on topline results of the RATIONALE 302 trial of tislelizumab compared to chemotherapy in patients with advanced unresectable or metastatic ESCC who received prior systemic treatment.

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What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
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On 27 January, the company announced that RATIONALE 302 demonstrated a statistically significant improvement in overall survival in the intention-to-treat (ITT) population for tislelizumab versus chemotherapy. The therapy’s safety profile was reportedly consistent with its known risks, with no new safety signals noted. BeiGene said it plans to discuss the RATIONALE 302 data with global health authorities and present data at a forthcoming medical conference.

While the LoA prior to this news was 61%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has upped the LoA to 71%. The trial is the fourth positive Phase III for tislelizumab and the first in the Phase III programme for gastrointestinal cancers composed of liver, stomach and ESCC, according to the company statement. Global sales are predicted to be $1.4bn by 2026, as per GlobalData consensus forecasts. The company’s market cap is H$260.43bn ($33bn).

by Jennifer C. Smith-Parker is Senior Editor  for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
Enter your details here to receive your free Report.

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