Taletrectinib receives approval from US FDA for NSCLC subtype
The US FDA has approved taletrectinib for advanced ROS1-positive NSCLC following positive trial results.
Nuviation Bio’s (CA, USA) Ibtrozi™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive NSCLC, has been approved by the US FDA following positive results from the TRUST-I and TRUST-II clinical trials, which demonstrated high response rates and sustained durability.
ROS1-positive NSCLC is a rare and aggressive form of lung cancer, which accounts for roughly 3000 new cases of advanced NSCLC in the US every year. Within this patient population, metastases to the brain are common and a leading cause of disease progression and mortality.
“Patients living with advanced ROS1+ non-small cell lung cancer and their healthcare providers are in need of new treatment options” commented Nathan Pennel, TRUST study investigator.
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Taletrectinib, a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI), has now received FDA approval, and is designed to penetrate the central nervous system and address some of the outstanding challenges of treating ROS1-positive NSCLC. This approval of taletrectinib is supported by one of the largest global clinical programs in ROS1+NSCLC, with over 300 patients enrolled in the pivotal TRUST-1 and TRUST-II studies.
In TRUST-I, taletrectinib achieved a confirmed overall response (cORR) rate of 90% in TKI-naïve patients, a median follow-up of 40 months and a longest duration of response (DOR) of 46.9 months and ongoing. The TRUST-II trial reinforced the results of the TRUST-I trial with a cORR of 85%, a median-follow-up of 19 months, and a longest observed DOR of 30.4 months and ongoing.
Positive results were also seen in patients previously treated with a ROS1 TKI who were treated with talectrectinib in the TRUST-I and II studies, achieving cORRs of 52% and 52%, respectively. Additionally, in the TRUST-I trial, a median DOR of 13.3 months was observed in these patients, while a median DOR of 19.4 months was seen in the TRUST-II trial.
“IBTROZI’s durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients. I believe this now-approved therapy offers providers and patients a promising new option for the treatment of advanced ROS1+ NSCLC,” concluded Pennell.