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October 3, 2019

Keytruda approved in China as a monotherapy for NSCLC

Merck has announced that Keytruda has been approved by the Chinese National Medical Products Administration (NMPA) as a monotherapy for first-line treatment of local advanced or metastatic non-small cell lung cancer (NSCLC).

By Allie Nawrat

Merck has announced that Keytruda has been approved by the Chinese National Medical Products Administration (NMPA) as a monotherapy for first-line treatment of local advanced or metastatic non-small cell lung cancer (NSCLC).

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Keytruda’s approval was based upon the results of the international, randomised, active-controlled trial Phase III Keynote-042 trial, which included an extension study in Chinese patients.

In the extension study, Keytruda demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy in patients whose tumour expressed programmed death-ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 50, as measured by a NMPA-approved test.

The Keynote-042 study trailed Stage III NSCLC patients who were not candidates for surgical resection or definitive chemoradiation, as well as metastatic NSCLC patients whose tumours expressed PD-L1 and who had not receive prior systemic treatment.

This comes a few months after NMPA’s approval of Keytruda in combination with chemotherapy for first-line treatment of metastatic non-squamous NSCLC patients.

Merck oncology clinical research vice-president Dr Jonathan Cheng said: “Keytruda is now the first anti-PD-1 therapy approved in China as both a monotherapy and in combination with chemotherapy in the first-line setting for appropriate patients with advanced non-small cell lung cancer.

“For patients for whom combination therapy is not preferred, KEYTRUDA monotherapy represents an important new treatment option that has demonstrated a significant improvement in survival outcomes.”

Guangdong Lung Cancer Research Institute honorary director Professor Yi-Long Wu said: “New treatment options that can help improve survival outcomes are desperately needed in China, as lung cancer remains the leading cause of cancer deaths in this country.

“In Keynote-042, Keytruda monotherapy demonstrated a survival benefit, compared with chemotherapy alone, across histologies in patients with either locally advanced or metastatic non-small cell lung cancer whose tumours expressed PD-L1 in at least 1% of tumour cells.”

Keytruda is an anti-PD-L1 humanised monoclonal antibody approved for 14 cancer types across the world.

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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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