Nuvation Bio's Ibtrozi For ROS1-Positive Lung Cancer Wins FDA Approval

The U.S. Food and Drug Administration (FDA) on Wednesday approved Nuvation Bio Inc.’s NUVB 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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