Keytruda Monotherapy Approved for 1L PD-L1-Positive NSCLC in China

October 11, 2019

Impact: High

• Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic NSCLC tumors with PD-L1 expression of at least 1% (TPS ≥1%, determined by an NMPA-approved test), without EGFR or ALK genomic mutations.
• The approval is based on data from Chinese patients in the global Phase 3 KEYNOTE-042 trial (NCT02220894) and a separate China extension study (NCT03850444).
• Patients with PD-L1 expression ≥1% treated with Keytruda (n=128) vs. platinum-based chemotherapy (n=134) showed mOS = 20.0 months vs. 13.7 months.
• Results from the China extension study were presented at the IASLC World Conference on Lung Cancer in September 2019 (abstract MA11.02).

inThought Analysis

Merck notes that this is the first Chinese approval for an anti-PD-1 product both as monotherapy and in combination with chemotherapy in 1L NSCLC. Keytruda was also the first anti-PD-1 therapy approved for multiple tumor types in China. It was approved for 1L metastatic non-squamous NSCLC in combination with chemotherapy in April 2019, and for advanced melanoma in July 2018.

The Chinese PD-1 axis inhibitor market continues to gain momentum, with at least three antibodies from Chinese companies now approved, along with Opdivo (NSCLC) and Keytruda (melanoma, NSCLC). Jiangsu Hengrui’s camrelizumab was approved in May 2019 for cHL, joining Innovent/Lilly’s Tyvyt (sintilimab; cHL) and Junshi’s Tuoyi (toripalimab; melanoma). BeiGene’s tislelizumab is in Phase 3 trials for 1L squamous and non-squamous NSCLC, and is under priority review for both urothelial carcinoma and cHL.

Source: Merck Press Release