Drugs

Maria Babak: A Meaningful Step Forward for ROS1-Positive NSCLC

Maria (Masha) Babak/LinkedIn

Jul 8, 2025, 17:57

Maria Babak: A Meaningful Step Forward for ROS1-Positive NSCLC

Maria Babak, Head of The Babak Lab and Assistant Professor at City University of Hong Kong, shared The Babak Lab’s post on LinkedIn, adding:

“A meaningful step forward for ROS1 + NSCLC.

Strong intracranial activity, durable responses, and once-daily dosing – taletrectinib raises the standard for both frontline and post-TKI care.

Exactly the kind of progress that matters most to patients with limited options.”

Quoting The Babak Lab’s post:

“Clinical Mondays: FDA Approves Taletrectinib for ROS1⁺ NSCLC—A Next-Gen Option with Strong CNS Activity

On June 11, 2025, the FDA approved Ibtrozi (taletrectinib) for adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC), expanding the arsenal of targeted therapies for this rare but aggressive lung cancer subtype.

Study Focus:

Evaluate the safety and efficacy of taletrectinib in both treatment-naïve and previously treated ROS1+ NSCLC patients, including those with CNS metastases.

Clinical Highlights:

Phase 2 TRUST-I and TRUST-II trials (China + global)
ORR in treatment-naïve patients: 90% (TRUST-I), 85% (TRUST-II)
ORR in previously treated patients: 52–62%
Duration of response ≥6 months in 70–83% of responders
Intracranial responses in 63–73% of patients with brain metastases

Key Findings:

High response rates in both 1L and post-TKI settings
Durable responses across patient subgroups
Strong CNS activity
Once-daily oral dosing (600 mg, fasting)
Safety profile includes hepatotoxicity, QTc prolongation, pneumonitis, fractures

Conclusion:

Taletrectinib offers a potent new treatment option for ROS1+ NSCLC with meaningful intracranial efficacy. It expands frontline and salvage therapy choices, especially for patients with brain metastases or prior TKI exposure.

Image generated using Sora by OpenAI.”

Learn more about the FDA’s approval of taletrectinib for ROS1-positive non-small cell lung cancer.

Maria Babak