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Related Concept Videos

Rous Sarcoma Virus (RSV) and Cancer01:03

Rous Sarcoma Virus (RSV) and Cancer

Rous Sarcoma virus or RSV was discovered by F. Peyton Rous in the year 1911 as a filterable transmissible agent that could cause tumors in chickens. He won a Nobel Prize for this discovery in 1966. His experiments clearly demonstrated that some cancers could be caused by infectious agents and led to the discovery of many more cancer-causing viruses in animals as well as humans.
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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.

Michael I Barbato1, Diana Bradford1, Yi Ren1

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|June 14, 2024
PubMed
Summary
This summary is machine-generated.

Repotrectinib (Augtyro) is FDA-approved for ROS1-positive non-small cell lung cancer (NSCLC). It shows high response rates in treatment-naïve patients and significant efficacy in those previously treated with ROS1 tyrosine kinase inhibitors.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Non-small cell lung cancer (NSCLC) often harbors ROS1 gene fusions.
  • Targeted therapies, such as ROS1 tyrosine kinase inhibitors (TKIs), have improved outcomes.
  • Resistance to prior TKIs remains a challenge in ROS1-positive NSCLC management.

Purpose of the Study:

  • To evaluate the efficacy and safety of repotrectinib for ROS1-positive NSCLC.
  • To assess repotrectinib's effectiveness in both treatment-naïve and pre-treated patient populations.
  • To provide data supporting the FDA approval of repotrectinib.

Main Methods:

  • TRIDENT-1 trial, a single-arm study with multiple patient cohorts.
  • Primary endpoint: Objective Response Rate (ORR) by blinded independent central review (BICR).
  • Efficacy assessed in treatment-naïve and previously treated (prior ROS1 TKI and/or chemotherapy) patients.

Main Results:

  • ORR was 79% in treatment-naïve ROS1-positive NSCLC patients (median duration of response: 34.1 months).
  • ORR was 38% in patients previously treated with a ROS1 TKI (median duration of response: 14.8 months).
  • Responses, including in CNS metastases and in patients with resistance mutations, were observed in both cohorts.

Conclusions:

  • Repotrectinib demonstrates significant efficacy in ROS1-positive NSCLC, including in patients who progressed on prior ROS1 TKIs.
  • The drug offers a new treatment option for both treatment-naïve and pre-treated patients.
  • Robust evidence supports repotrectinib's role in managing advanced or metastatic ROS1-positive NSCLC.