FDA Approves Repotrectinib for Treatment of ROS1-Positive NSCLC

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Repotrectinib is a tyrosine kinase inhibitor (TKI) that targets ROS1 and is administered as an oral therapy for treatment of locally advanced or metastatic ROS1-positive non–small cell lung cancer.

The FDA has approved repotrectinib (Augtyro; Bristol Myers Squibb) for the treatment of individuals with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC). Repotrectinib is a tyrosine kinase inhibitor (TKI) that targets ROS1 and is administered as an oral therapy.

3d rendered illustration of lung cancer 3D illustration | Image Credit: appledesign - stock.adobe.com

appledesign - stock.adobe.com

The agency has approved the dosing of 160 mg once daily for 14 days with an increase to 160 mg twice daily until disease progression or unacceptable toxicity is reached, according to the press release.

“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, MD, an attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and assistant professor of Medicine at Harvard Medical School, said in the press release. “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”

About The TRIDENT-1 Trial

Trial Name: A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

ClinicalTrials.gov Identifier: NCT03093116

Sponsor: Turning Point Therapeutics Inc

Completion Date: February 2028

The approval was based on data from the open-label phase 1/2 trial, TRIDENT-1, evaluating repotrectinib in patients who were previously TKI pretreated or TKI naïve. The primary endpoint for those who were TKI-naïve was objective response rate (ORR), defined as the percentage of individuals who were treated and had a partial response (PR) or complete response (CR). Key secondary endpoints included duration of response (DOR), progression-free survival, and intracranial response. The phase 1 portion of the trial included a dose escalation that informed the dose in the phase 2 portion.

There are additional analyses being conducted, according to the press release. Additionally, patients who had symptomatic brain metastases were excluded from the study.

The results of the study showed an ORR of 79%, with a median DOR being 34.1 months for those who were TKI-naïve. Approximately 6% achieved a CR and 73% experienced a PR.For those who were pretreated with 1 prior ROS1 TKI and no prior chemotherapy, the ORR was 38% and median DOR was 14.8 months, according to the results. Approximately 5% achieved a CR and 32% achieved a PR. Furthermore, for those who had measurable central nervous system metastases, there were responses in the intracranial lesions in 7 of 8 TKI-naïve individuals and 5 of 12 TKI-pretreated individuals.

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“While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” Samit Hirawat, MD, executive vice president and chief medical officer of Global Drug Development at Bristol Myers Squibb, said in the press release. “As the only approved next-generation TKI for ROS1-positive NSCLC patients, [repotrectinib] builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”

Repotrectinib is associated with “CNS effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal features, and embryo-fetal toxicity,” according to the press release. The drug is intended to help minimize events that lead to treatment resistance in the patient population with NSCLC. The company expects to make the drug available to individuals in the United States in mid-December 2023.

Reference

US Food and Drug Administration approves Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of locally advanced or metastatic ROS1-positive non­–small cell lung cancer (NSCLC). News release. Businesswire. November 15, 2023. Accessed November 16, 2023. https://www.businesswire.com/news/home/20231115632242/en/U.S.-Food-and-Drug-Administration-Approves-Augtyro%E2%84%A2-repotrectinib-a-Next-Generation-Tyrosine-Kinase-Inhibitor-TKI-for-the-Treatment-of-Locally-Advanced-or-Metastatic-ROS1-Positive-Non-Small-Cell-Lung-Cancer-NSCLC

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