The U.S. Food and Drug Administration (FDA) on Wednesday approved Nuvation Bio Inc.’s Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

The FDA approval of Ibtrozi is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies.

In the TRUST-I trial, Ibtrozi achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve (untreated) patients.

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TRUST-II trial showed a cORR of 85% in TKI-naïve patients.

The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology.

For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing.

For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024.

Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label.

Across the pivotal studies, consistent results were also observed among patients previously treated with a ROS1 TKI (TKI-pretreated).

In TRUST-I, treatment with Ibtrozi achieved a cORR of 52% and a median DOR of 13.2 months for TKI-pretreated patients, with a median follow-up for responses of 33 months.

In TRUST-II, treatment with Ibtrozi achieved a cORR of 62%. As of October 2024, the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months.

An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24).

Price Action: NUVB stock is trading lower by 16.8% to $2.105 at last check Wednesday.

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