Abstract 36P
Background
Datopotamab deruxtecan (dato-DXd), an antibody-drug conjugate (ADC) targeting TROP2, has shown promising results in advanced/metastatic (a/m) non-small cell lung cancer (NSCLC). This systematic review and meta-analysis evaluated the efficacy and safety of dato-DXd in this population.
Methods
We searched PubMed, Embase, Cochrane, ASCO, and ESMO databases for studies examining dato-DXd in patients with a/m NSCLC. Outcomes included objective response rate (ORR), disease control rate (DCR), and incidence of adverse events (AEs). Random-effect models were used for analysis, and heterogeneity was assessed using the I² test.
Results
Seven clinical trials involving 914 a/m NSCLC patients treated with dato-DXd were included. Most patients received dato-DXd as monotherapy (6 mg/kg every threeweeks). Overall, 35% (95% CI, 27%–43%) achieved an ORR, and 78% (95% CI, 75%–81%) achieved a DCR. AEs led to dose reductions in 20% (95% CI, 17%–23%) and treatment discontinuation in 22% (95% CI, 10%–40%) of patients. Serious treatment-emergent AEs occurred in 30% (95% CI, 19%–45%). Common all-grade AEs included stomatitis (49%), nausea (48%), and alopecia (39%), with severe stomatitis, anemia, and nausea occurring in 9%, 7%, and 4% of patients, respectively. Interstitial lung disease (ILD) was reported in 7% of patients, with 4% experiencing grade ≥3 events.
Conclusions
Dato-DXd demonstrated notable efficacy, with an ORR of 35% and a DCR of 78% in heavily pretreated a/m NSCLC patients. However, the rate of AE was substantial, including treatment discontinuation in nearly one-quarter of patients. Ongoing studies on the activity and safety profile of dato-DXd in a/m NSCLC are awaited.
Table 36PPooled analyses of this meta-analysis
| Outcomes | Findings |
| ORR | 35% (95% CI, 27%–43%) |
| DCR | 78% (95% CI, 75%–81%) |
| Safety | Findings |
| Serious TRAEs | 30% (95% CI, 19%–45%) |
| ILD | 7% |
Legal entity responsible for the study
H.J.S. Kim.
Funding
Has not received any funding.
Disclosure
H.C. Freitas: Financial Interests, Personal, Other, Honoraria: MSD, Roche, Lilly, Pfizer, Takeda, BMS, Amgen, AstraZeneca, Merck; Financial Interests, Personal, Other, Support for attending meetings or travel: BMS, MSD, Pfizer, Roche, AstraZeneca, Takeda, Sanofi; Financial Interests, Personal, Advisory Board: MSD, Pfizer, Takeda, Roche, BMS, AstraZeneca, Sanofi; Financial Interests, Personal, Other, Full-part time employment of his spouse: AstraZeneca. V.C. Cordeiro de Lima: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Other, Honoraria: Roche Brasil, MSD Brasil, BMS Brasil, Janssen, Daiichi-Sankyo, Lilly, Pfizer, AstraZeneca; Financial Interests, Personal, Other, Support to attend scientific meetings and travels: AstraZeneca, Roche, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Roche Brasil, Amgen, Janssen, Daiichi-Sankyo, Pfizer, AstraZeneca, GSK; Financial Interests, Personal, Leadership Role, President: The Brazilian Group of Thoracic Oncology; Financial Interests, Personal, Leadership Role, Vice-President: Lung Cancer Steering Committee –Latin America Cooperative Oncology Group; Financial Interests, Personal, Leadership Role, Coordinator: Thoracic Cancer Committee of the Brazilian Society of Clinical Oncology. All other authors have declared no conflicts of interest.