STUDY OVERVIEW
STUDY OVERVIEW
DATROWAY was granted accelerated approval based on pooled data of patients with locally advanced or metastatic EGFRm NSCLC in two clinical studies1,3,4-7
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Study design
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Baseline characteristics
Efficacy and safety were evaluated in the TROPION-Lung05 and TROPION-Lung01 studies
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TROPION-Lung05 (PHASE II STUDY)
- Stage IIIB, IIIC, or IV NSCLC
- Previously treated with ≥1 line of systemic therapy, including a targeted therapy and platinum-based chemotherapy in the advanced or metastatic setting
- Presence of ≥1 actionable genomic alteration (eg, EGFR, ALK, ROS1, etc)
- ECOG performance status of 0 or 1
TROPION-Lung01 (PHASE III STUDY)
- Stage IIIB, IIIC, or IV NSCLC
- Those with AGA had 1-2 prior targeted therapies and platinum-based chemotherapy in the advanced or metastatic setting
- No prior docetaxel
- ECOG performance status of 0 or 1
DATROWAY
6 mg/kg IV Q3W
(n=137)*†
DATROWAY
6 mg/kg IV Q3W
(n=299)†
Docetaxel
75 mg/m2 IV Q3W
(n=305)†
EGFRm Pool: N=114
TROPION-Lung05 (n=77)
TROPION-Lung01 (n=37)
MAJOR EFFICACY OUTCOME:
- ORR by BICR per RECIST v1.1
ADDITIONAL EFFICACY OUTCOME:
- DOR by BICR
Treatment with DATROWAY was continued until disease progression or unacceptable toxicity.
Trop-2 testing was not required in these studies
SELECT EXCLUSION CRITERIA ACROSS BOTH STUDIES
- History of ILD/pneumonitis requiring treatment with steroids, ongoing ILD/pneumonitis, or clinically significant corneal disease at screening
- Brain metastases that were untreated and symptomatic‡
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Appendix: Study Design
TROPION-Lung054
TROPION-Lung05 is a global, phase II, single-arm, open-label study of DATROWAY in patients with advanced/metastatic NSCLC with actionable genomic alterations who progressed on or after targeted therapy and platinum-based chemotherapy.
- Eligibility: adults with pathologically documented advanced/metastatic NSCLC (stage IIIB/C or IV) and any of the following actionable genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET
- Patients were required to have received prior treatment with 1-2 cytotoxic therapies (including 1 platinum-containing regimen) in the metastatic setting and 1-2 targeted therapies
- Also required: documentation of radiographic disease progression during or after the previous regimen for advanced/metastatic NSCLC, measurable disease based on local imaging using RECIST v1.1, and ECOG performance status of 0 or 1
- Exclusion criteria included prior treatment with topoisomerase I-targeted chemotherapeutic agent or Trop-2-directed therapy, clinically active CNS metastases (untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control symptoms), history of ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis
- Patients with KRAS mutations were excluded as no targeted therapy was approved for this group at trial initiation
TROPION-Lung016
TROPION-Lung01 is a randomized, open-label, global, phase III study comparing the safety and efficacy of DATROWAY versus docetaxel in patients with advanced/metastatic NSCLC.
- Eligible patients had stage IIIB/C or IV NSCLC
- Patients without actionable genomic alterations must have only received platinum-based chemotherapy and anti–PD-1/PD-L1 immunotherapy
- Patients with eligible actionable genomic alterations (EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET) must have received 1-2 lines of targeted therapy and platinum-based chemotherapy, with or without anti–PD-1/PD-L1
- Exclusion criteria: active or untreated, symptomatic CNS metastases; current or suspected diagnosis or history of ILD/pneumonitis requiring steroids
- Patients were randomly assigned 1:1 (stratified by histology, actionable genomic alteration status, geographic region, and immediate previous therapy with anti–PD-1/PD-L1) to receive DATROWAY 6 mg/kg or docetaxel 75 mg/m2 intravenously Q3W until disease progression, unacceptable toxicity, or other reasons
- Crossover between study groups was not permitted
Most patients in the pooled analysis of the EGFRm subgroup were heavily pretreated1,2
Select EGFRm NSCLC baseline characteristics
|
DATROWAY (n=114) |
|
|---|---|
| Age | |
| Median (range), years | 63 (36–81) |
| ≥65 years of age, % | 43 |
| Sex, % | |
| Female | 63 |
| Race, % | |
| Asian | 70 |
| White | 22 |
| Hispanic/Latino | 2 |
| History of brain metastasis, % | 53 |
| Brain metastasis at baseline, %* | 33 |
| Liver metastasis at baseline, % | 20 |
| ECOG PS, % | |
| 0 | 32 |
| 1 | 68 |
| Nonsquamous, % | 97 |
| Squamous, % | 3 |
| EGFR mutations, % EGFR mutations in the efficacy population included exon 19, 20,† and 21 mutations, among others. | |
| Exon 19 deletions | 53 |
| Exon 21 L858R | 34 |
| T790M | 28 |
| Exon 20 insertion | 3 |
| Other EGFR mutations | 14 |
| Prior lines of therapy, % Patients with EGFRm NSCLC in TROPION-Lung05 and TROPION-Lung01 were heavily pretreated, with most patients having received at least 3 prior regimens in the locally advanced/metastatic setting. | |
| 1 | 4 |
| 2 | 39 |
| ≥3 | 57 |
| Prior systemic therapy, % | |
| EGFR-directed | 100 |
| Osimertinib | 84 |
| ≥2 prior lines of EGFR-targeted therapies | 49 |
| Platinum-containing | 99 |
| Anti-PD-1/PD-L1 | 28 |
*Patients who had brain metastases that were untreated and symptomatic were excluded.4,6
†Inclusive of both T790M and exon 20 insertion mutations.1
AGA, actionable genomic alteration; ALK, anaplastic lymphoma kinase; BICR, Blinded Independent Central Review; BRAF, proto-oncogene B-raf; CNS, central nervous system; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group performance status; EGFRm, epidermal growth factor receptor-mutated; ILD, interstitial lung disease; IV, intravenous; KRAS, Kirsten rat sarcoma virus; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; ORR, objective response rate; PD-1/PD-L1, programmed cell death protein 1/programmed death-ligand 1; Q3W, once every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1; Trop-2, trophoblast cell surface antigen 2.
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Efficacy data
Efficacy of DATROWAY was evaluated in the TROPION-Lung05 and TROPION-Lung01 studies