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The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

The median PFS was 4.4 months (95% CI, 4.2–5.6) in the Dato-DXd group and 3.7 months (95% CI, 2.9–4.2) in the docetaxel group (HR, 0.75; 95% CI, 0.62–0.91; P = .004).[9][Level of evidence B2]

The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

The median OS was 12.9 months (95% CI, 11.0–13.9) with Dato-DXd and 11.8 months (95% CI, 10.1–12.8) with docetaxel (HR, 0.94; 95% CI, 0.78–1.14; P = .530).

The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

In the nonsquamous histology subgroup, the median PFS was 5.5 months with Dato-DXd versus 3.6 months with docetaxel (HR, 0.63; 95% CI, 0.51–0.79). The median OS was 14.6 months with Dato-DXd versus 12.3 months with docetaxel (HR, 0.84; 95% CI, 0.68–1.05).

The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

In the squamous histology subgroup, the median PFS was 2.8 months with Dato-DXd versus 3.9 months with docetaxel (HR, 1.41; 95% CI, 0.95–2.08). The median OS was 7.6 months with Dato-DXd versus 9.4 months with docetaxel (HR, 1.32; 95% CI, 0.91–1.92).

The randomized, open-label, global phase III TROPION-Lung01 study (NCT04656652) compared the efficacy and safety of Dato-DXd with docetaxel in patients with pretreated advanced or metastatic NSCLC. Patients received Dato-DXd (6 mg/kg) (n = 299) or docetaxel (75 mg/m2) (n = 305) once every 3 weeks. Dual primary end points were PFS and OS. Objective response rate, duration of response (DOR), and safety were secondary end points.[9]

Grade 3 or higher treatment-related adverse events occurred in 25.6% of patients who received Dato-DXd and 2.1% of patients who received docetaxel. Interstitial lung disease/pneumonitis occurred in 8.8% of patients in Dato-DXd group and 4.1% of patients in the docetaxel group.

The single-arm, open-label, phase II TROPION-Lung05 (NCT04484142) study enrolled adult patients with stage IIIB, IIIC, or IV NSCLC. Patients had at least one documented activating EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14-skipping, or RET genomic alteration. All patients received Dato-DXd at a dose of 6.0 mg/kg once every 3 weeks. The primary end point was objective response rate by blinded independent central review. Secondary end points included DOR, PFS, OS, pharmacokinetics, and safety. Overall, 56.9% of patients had EGFR pathogenic variants and 24.8% of patients had ALK rearrangements.[10]

The single-arm, open-label, phase II TROPION-Lung05 (NCT04484142) study enrolled adult patients with stage IIIB, IIIC, or IV NSCLC. Patients had at least one documented activating EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14-skipping, or RET genomic alteration. All patients received Dato-DXd at a dose of 6.0 mg/kg once every 3 weeks. The primary end point was objective response rate by blinded independent central review. Secondary end points included DOR, PFS, OS, pharmacokinetics, and safety. Overall, 56.9% of patients had EGFR pathogenic variants and 24.8% of patients had ALK rearrangements.[10]

The median treatment duration was 4.4 months (range, 0.7–20.6). The median DOR was 7.0 months (95% CI, 4.2–9.8), and the overall disease control rate was 78.8% (95% CI, 71.0%–85.3%).[10][Level of evidence C3]

The single-arm, open-label, phase II TROPION-Lung05 (NCT04484142) study enrolled adult patients with stage IIIB, IIIC, or IV NSCLC. Patients had at least one documented activating EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14-skipping, or RET genomic alteration. All patients received Dato-DXd at a dose of 6.0 mg/kg once every 3 weeks. The primary end point was objective response rate by blinded independent central review. Secondary end points included DOR, PFS, OS, pharmacokinetics, and safety. Overall, 56.9% of patients had EGFR pathogenic variants and 24.8% of patients had ALK rearrangements.[10]

The confirmed objective response rate was 35.8% (95% CI, 27.8%–44.4%) overall. The rate was 43.6% (95% CI, 32.4%–55.3%) in patients with EGFR pathogenic variants and 23.5% (95% CI, 10.7%–41.2%) in patients with ALK rearrangements.

The single-arm, open-label, phase II TROPION-Lung05 (NCT04484142) study enrolled adult patients with stage IIIB, IIIC, or IV NSCLC. Patients had at least one documented activating EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14-skipping, or RET genomic alteration. All patients received Dato-DXd at a dose of 6.0 mg/kg once every 3 weeks. The primary end point was objective response rate by blinded independent central review. Secondary end points included DOR, PFS, OS, pharmacokinetics, and safety. Overall, 56.9% of patients had EGFR pathogenic variants and 24.8% of patients had ALK rearrangements.[10]

Grade 3 or higher treatment-related adverse events occurred in 28.5% of patients. The most common treatment-related adverse event was stomatitis (any grade, 56.2%; grade ≥3, 9.5%).

A pooled analysis of patients with EGFR-altered NSCLC (n = 117) who received Dato-DXd in TROPION-Lung05 (n = 78) or TROPION-Lung01 (n = 39) was completed and findings were published in abstract form.[11]The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Dato-DXd for the treatment of adult patients with locally advanced or metastatic, EGFR-altered NSCLC with disease progression during or after treatment with an EGFR TKI and platinum-based chemotherapy.

A pooled analysis of patients with EGFR-altered NSCLC (n = 117) who received Dato-DXd in TROPION-Lung05 (n = 78) or TROPION-Lung01 (n = 39) was completed and findings were published in abstract form.[11]The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Dato-DXd for the treatment of adult patients with locally advanced or metastatic, EGFR-altered NSCLC with disease progression during or after treatment with an EGFR TKI and platinum-based chemotherapy.

The objective response rate was 42.7% (95% CI, 33.6%–52.2%) in patients who received Dato-DXd per blinded independent central review, including a complete response rate of 4.3% and a partial response rate of 38.5%.

A pooled analysis of patients with EGFR-altered NSCLC (n = 117) who received Dato-DXd in TROPION-Lung05 (n = 78) or TROPION-Lung01 (n = 39) was completed and findings were published in abstract form.[11]The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Dato-DXd for the treatment of adult patients with locally advanced or metastatic, EGFR-altered NSCLC with disease progression during or after treatment with an EGFR TKI and platinum-based chemotherapy.

The percentage of patients with stable disease was 41.0%, and the disease control rate was 86.3% (95% CI, 78.7%–92.0%).

A pooled analysis of patients with EGFR-altered NSCLC (n = 117) who received Dato-DXd in TROPION-Lung05 (n = 78) or TROPION-Lung01 (n = 39) was completed and findings were published in abstract form.[11]The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Dato-DXd for the treatment of adult patients with locally advanced or metastatic, EGFR-altered NSCLC with disease progression during or after treatment with an EGFR TKI and platinum-based chemotherapy.

The median DOR was 7.0 months (95% CI, 4.2–9.8). The median PFS was 5.8 months (95% CI, 5.4–8.2), and the median OS was 15.6 months (95% CI, 13.1–19.0).

A pooled analysis of patients with EGFR-altered NSCLC (n = 117) who received Dato-DXd in TROPION-Lung05 (n = 78) or TROPION-Lung01 (n = 39) was completed and findings were published in abstract form.[11]The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Dato-DXd for the treatment of adult patients with locally advanced or metastatic, EGFR-altered NSCLC with disease progression during or after treatment with an EGFR TKI and platinum-based chemotherapy.

Patients previously treated with osimertinib (n = 96) had an objective response rate of 44.8% (95% CI, 34.6%–55.3%), including a complete response rate of 4.2%, a partial response rate of 40.6%, and a stable disease rate of 38.5%. The median DOR was 6.9 months (95% CI, 4.2–9.8), and the disease control rate was 85.4% (95% CI, 76.7%–91.8%). The median PFS was 5.7 months (95% CI, 5.4–7.9), and the median OS was 14.7 months (95% CI, 13.0–18.3).