A Improves PFS According to two phase III trials presented here, treatment with an investigational TROP2-directed antibody-drug conjugate (ADC) significantly improved progression-free survival (PFS) in patients with previously treated metastatic breast cancer and non-small cell lung cancer (NSCLC). Aditya Bardia, MD, of Mass General Cancer Center and Harvard Medical School in Boston, reported that datopotamab deruxtecan (Dato-DXd) had a median PFS of 6.9 months in TROPION-Breast01 patients with hormone receptor (HR)-positive/HER2-negative breast cancer, compared to 4.9 months in those treated with chemotherapy (HR 0.63, 95% CI 0.52-0.76, P0.0001). According to Aaron Lisberg, MD, of the University of California, Los Angeles, the PFS benefit for the entire population of patients with previously treated NSCLC in TROPION-Lung01 was less significant with the ADC, with a median of 4.4 months versus 3.7 months for patients treated with docetaxel (HR 0.75, 95% CI 0.62-0.91, P=0.004). The annual congress of the European Society for Medical Oncology (ESMO) featured presentations of both studies. The PFS benefit in the lung trial was driven by patients with non-squamous NSCLC, who had a median PFS of 5.6 months with Dato-DXd compared with 3.7 months with docetaxel (HR 0.63, 95% CI 0.51-0.78). However, Dato-DXd had a worse prognosis for patients with squamous histology (median PFS of 2.8 months versus 3.9 months; HR 1.38, 95% CI 0.94-2.02). “Clearly Dato-DXd has benefit over standard-of-care docetaxel in second-line non-squamous NSCLC, and over later-line HR-positive metastatic breast cancer after one chemotherapy,” said ESMO-designated discussant Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York City.
“I think translational research is urgently needed if we were ultimately to deliver on the promise of these agents in the clinic,” he added, adding that its utility over, or prior to, other newer regimens and agents in the same space “is uncertain.” TROPION-Breast01

Informative illustration of lung cancer stages | Free Vector
Patients were eligible for TROPION-Breast01opens in a new tab or window if they had experienced progression on or were unsuitable for endocrine therapy and had received one to two previous lines of systemic chemotherapy. The study included 732 patients (median age 54-56 years) who were randomized to Dato-DXd or an investigator’s choice of chemotherapy.
With Dato-DXd, PFS was 6.9 months, according to the investigator, compared to 4.5 months with chemotherapy (HR 0.64, 95% CI 0.53-0.76). The objective response rates, or ORRs, were 36.4 percent and 21.9 percent, respectively. News about medicine from around the web Los Angeles Times
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PEPFAR was spared by the rescinding ax. But how does it look now? opens in a new window or tab Overall survival (OS) results were not mature at the time of the analysis, but at a median follow-up of 9.7 months, there was a trend favoring Dato-DXd (HR 0.84, 95% CI 0.62-1.14), Bardia reported.
Dato-DXd treatment averaged 6.7 months, while chemotherapy treatment averaged 4.1 months. While the Dato-DXd arm had a lower rate of grade 3 TRAEs (21% vs. 45%), the chemotherapy arm had a higher rate of treatment-related adverse events (TRAEs) (94% vs. 86%). The same held true for the rates of dose interruption (12% vs 25%) and dose reduction (21% vs 30%).
Stomatitis, nausea, and dry eye were the most common TRAEs in the Dato-DXd arm, and the majority of them were of a low grade. Neutropenia and anemia were the most common TRAEs in the chemotherapy group. There were nine cases of interstitial lung disease (ILD) in the Dato-DXd arm, two of which were grade ≥3.
“It leaves several unanswered questions,” Chandarlapaty said of the study’s findings, which would lead him to prescribe Dato-DXd rather than additional chemotherapy after one to two prior lines in unselected metastatic HR-positive/HER2-negative breast cancer. He noted there are two ADCs — sacituzumab govitecan and trastuzumab deruxtecan — approved for HR-positive breast cancer, adding that he had no answer as to whether he would use Dato-DXd over one of those drugs.
“Can I also administer these medications sequentially?” He inquired. “And which small molecule might work in this situation, Dato-DXd or something else?” TROPION-Lung01
604 patients with advanced NSCLC who had previously been treated and were eligible for second-line therapy were included in TROPION-Lung01opens in a new tab or window, with a median age of 63-64 years and 61-69% being men. Patients who received Dato-DXd had an ORR that was significantly higher than that of patients who received docetaxel (26.4% vs. 12.8%). Median duration of response was 7.1 months and 5.6 months, respectively.
The ORR in patients with non-squamous NSCLC was 31.2% with Dato-DXd versus 12.8% with docetaxel, while those with squamous NSCLC had ORRs of 9.2% versus 12.7%.
At the time of the data cutoff, the interim OS analysis revealed a trend in favor of Dato-DXd across the entire study population (12.4 months vs. 11.0 months; HR 0.90, 95% CI 0.72-1.13), but this did not reach the predetermined threshold for statistical significance. Again, non-squamous NSCLC patients outperformed squamous NSCLC patients in terms of OS benefit (HR 1.32, 95% CI 0.87-2.00 vs. 0.77, 0.59-1.01). Dato-DXd had a median treatment duration of 4.2 months, while docetaxel had a median duration of 2.8 months.