In the data shared at the ESMO Congress, investigators noted that in patients with advanced ROS1-positive NSCLC who were TKI-naive and in patients who were TKI-pretreated, tumors shrank in 89% and 56% of patients, respectively. Furthermore, the agent demonstrated durable responses and prolonged PFS. The median DOR was 44 months in TKI-naive patients and the median PFS was 46 months in the same patient group. Additionally, the agent had a favorable safety and tolerability profile.
More Information on the Use of Taletrectinib
More than one million people globally are diagnosed with NSCLC every year, and approximately 2% of those have ROS1-positive mutations. Of these patients, 35% have tumors that spread to their brain, which increases to 55% for those whose cancer has progressed following first-line treatment, according to the news release. In turn, this creates an unmet need for patients. The news release notes that this priority review designation of taletrectinib underscores the advancements that the agent may offer for this patient population.
Glossary:
Breakthrough Therapy Designation: a process that speeds up the development and review of drugs for serious conditions.
Confirmed Objective Response Rate (cORR): the percentage of patients in a study who have a confirmed best objective response to a treatment.
Duration of Response (DOR): the amount of time a patient responds to treatment without their cancer growing or spreading.
New Drug Application (NDA): a request to approve a new drug for sale and marketing in the United States.
Orphan Drug Designation: a status given to drugs that are being developed to treat rare diseases or conditions.
Prescription Drug User Fee Act (PDUFA): a law that allows the FDA to collect fees from companies that submit certain human drug applications for review.
Progression-Free Survival (PFS): a measure used in clinical trials to evaluate the effectiveness of cancer treatments.
ROS1 TKI: a drug that treats cancers caused by the ROS1 gene, which encodes a receptor tyrosine kinase.
The Food and Drug Administration (FDA): a federal agency that protects the public's health.
Taletrectinib, which is an oral, potent, central nervous system-active, selective agent, previously received orphan drug designation from the FDA and is currently the only ROS1 TKI in development that has received breakthrough therapy designation from the FDA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
