Is Pralsetinib Effective in Treatment?

The efficacy of Pralsetinib was investigated in a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385).

Is Pralsetinib Effective in Treatment?

A total of 220 patients aged 26 to 87 years with RET-altered tumors were enrolled in the trial. RET gene alterations were prospectively identified by local laboratories using next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), or other detection methods. The primary efficacy endpoints were overall response rate (ORR) and duration of response (DOR), assessed by a blinded independent review committee (BIRC) in accordance with the RECIST 1.1 criteria. The trial was conducted at multiple centers across the United States, Europe, and Asia.

Efficacy was evaluated in 87 participants with RET fusion-positive non-small cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy. The ORR was 57% (95% confidence interval [CI]: 46%, 68%); 80% of responders achieved a DOR of 6 months or longer. Additionally, efficacy was assessed in 27 treatment-naive participants who had never received systemic therapy. The ORR in this cohort was 70% (95% CI: 50%, 86%); 58% of responders had a DOR of 6 months or longer.

Administration of Pralsetinib

Patients should take GAVRETO® on an empty stomach (no food intake for at least 2 hours before dosing and at least 1 hour after dosing).

For patients with non-small cell lung cancer or thyroid cancer, the presence of RET gene fusion must be confirmed prior to treatment.

Measure serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

Monitor blood pressure. Pralsetinib is contraindicated in patients with uncontrolled hypertension.

For females of reproductive potential, verify pregnancy status before initiating treatment.

Safety Monitoring During Pralsetinib Treatment

During treatment, patients should be monitored for the following adverse events:

Interstitial Lung Disease (ILD)/Pneumonitis

Monitor patients for pulmonary symptoms suggestive of ILD/pneumonitis (e.g., dyspnea, cough, and fever).

Hypertension

Patients with uncontrolled hypertension should not start GAVRETO®. Blood pressure control should be optimized before treatment initiation. Monitor blood pressure during the first week of treatment, then at least once monthly thereafter, with frequency adjusted based on clinical needs. Initiate or adjust antihypertensive therapy as appropriate.

Hepatotoxicity

Measure AST and ALT levels before starting GAVRETO®. During the first 3 months of treatment, monitor AST and ALT every 2 weeks; thereafter, monitor once monthly, with adjustments to frequency based on clinical requirements.