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November 27, 2019

Merck’s Keytruda secures third approval in China

Merck’s Keytruda (pembrolizumab) anti-PD-1 therapy has secured approval in China for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.

Merck’s Keytruda (pembrolizumab) anti-PD-1 therapy has secured approval in China for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.

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China’s National Medical Products Administration (NMPA) approved the combination of Keytruda plus carboplatin and paclitaxel from overall survival findings of Phase 3 Keynote-407 trial, as well as interim data that were part of an extension of the global study in Chinese patients.

Results demonstrated that the Keytruda / chemotherapy combination led to a 36% reduction in the risk of death compared with chemotherapy alone. In Chinese patients, the immunotherapy regimen led to a 56% reduction in the risk of death versus chemotherapy alone.

The China extension study also showed an improvement in progression-free survival, with a 68% reduction in the risk of progression or death compared to chemotherapy alone.

Merck, known as MSD outside the US and Canada, said the approval is the third for first-line NSCLC in China in less than one year.

Merck research laboratories vice-president for oncology clinical research Jonathan Cheng said: “This approval expands our current lung cancer indications in China to include Keytruda in combination with chemotherapy in patients with squamous cell carcinoma, a particularly difficult-to-treat type of lung cancer.

“Importantly, Keytruda provides a foundation for the treatment of lung cancer in China and now more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with Keytruda.”

More than 787,000 cases of lung cancer are diagnosed in China every year, with over 631,000 deaths. NSCLC accounts for nearly 85% of all cases.

Keytruda is a humanised monoclonal antibody, which increases the ability of the body’s immune system to help identify and fight tumour cells.

At present, more than 1,000 trials are studying Keytruda across several cancers and treatment settings.

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Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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