The Babak Lab shared on LinkedIn:
“A new targeted option after ROS1 inhibitor resistance in lung cancer.
On July 22, the FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have already received at least one ROS1 tyrosine kinase inhibitor (TKI).
Resistance to first- and second-generation ROS1 TKIs remains a major clinical hurdle. Zidesamtinib offers a new targeted pathway for patients who progressed on prior therapies like lorlatinib, repotrectinib, or taletrectinib
Key Insights:
- Efficacy was evaluated in 117 patients with previously treated locally advanced or metastatic ROS1-positive NSCLC in the ARROS-1 trial.
- The confirmed overall response rate (ORR) was 44% across the efficacy population.
- Among responders, 82% maintained their response for at least 6 months, and 69% for at least 12 months.
- ORR was 49% in patients previously treated with one ROS1 TKI and 38% in those who had received two or more ROS1 TKIs.
- The recommended dose is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
- Important safety warnings include CNS adverse reactions, QTc prolongation, interstitial lung disease/pneumonitis, skeletal fractures, pancreatic toxicity, and other treatment-related risks.
Conclusion: Zidesamtinib addresses a critical unmet need by delivering durable responses even in heavily pretreated ROS1-positive lung cancer.
Image generated using Sora by OpenAI.”
FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
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