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Introduction
The FDA has recently approved a new ALK inhibitor called Ensacove (ensartinib), marking a significant development in the treatment of ALK-positive non-small cell lung cancer (NSCLC)12. This drug, developed by Xcovery Holdings, a subsidiary of China’s Betta Pharmaceuticals, is now available in the U.S. as a first-line treatment for patients who have not previously received an ALK inhibitor12.
A New Player in a Competitive Market
Ensacove is the first innovative targeted lung cancer drug from a Chinese company to reach the global market. It is a second-generation ALK inhibitor that has demonstrated superior efficacy compared to the first-generation drug, Xalkori. However, the market is already occupied by other ALK inhibitors, such as Roche’s Alecensa, Takeda’s Alunbrig, and Pfizer’s Lorbrena, which have also shown to outperform Xalkori and have already secured first-line approvals. Novartis also has an ALK inhibitor called Zykadia, which was approved for first-line treatment based on a comparison with chemotherapy.
Clinical Trial Results and Efficacy
The FDA approval of Ensacove was based on results from the eXalt3 study, which were published in JAMA Oncology more than three years ago56. The study revealed that, compared to Xalkori, Ensacove reduced the risk of disease progression or death by 44% in patients with first-line ALK-positive NSCLC56. While a 12% lower risk of death was observed with Ensacove, this difference was not statistically significant56. The data cited by the FDA, which will be featured on Ensacove’s U.S. label, appear to come from a longer follow-up of the eXalt3 study56.
Although Ensacove is entering a market dominated by Big Pharma companies, it has a unique position as a first-in-class targeted therapy developed by a Chinese company34. The drug was initially approved in China in 2020 under the name Beimeina, where it moved into the first-line setting in 2022. Ensacove also has an ongoing phase 3 study in the adjuvant setting, although only among Chinese patients.
It is important to note that Roche’s Alecensa, a leading ALK inhibitor, showed a 47% reduction in the risk of disease worsening or death compared to Xalkori in the phase 3 ALEX trial. This number was later expanded to 57% at the trial’s final progression-free survival analysis. Alecensa has also received FDA approval to treat ALK-positive NSCLC as an adjuvant treatment following tumor resection. This puts Ensacove in a competitive space with other well established treatments, although the 44% reduction in risk of disease progression or death compared to Xalkori is a positive signal for its clinical effectiveness.
