UPDATED: Gilead keeps pushing trove of Trodelvy data as it seeks to become new standard of care in TNBC
Gilead is continuing to churn out results for its newly approved drug Trodelvy, and #ESMO21 is the latest stop on the data train.
The biopharma put out new quality of life data in second-line patients with metastatic triple-negative breast cancer, saying that a sub-analysis from their Phase III study showed significant and clinically meaningful improvements in health-related quality of life over standard of care.
It’s a result that likely boosts Gilead’s case to bring Trodelvy to earlier lines of care, coming just three months after the company put out survival data at #ASCO21.
Trodelvy received full FDA approval in April to treat metastatic TNBC patients in the second line or later, in addition to an accelerated OK in urothelial carcinoma the same month.
In an interview Thursday morning, Gilead head of oncology Daejin Abidoye told Endpoints News the new data represent the next step in the biopharma’s goal to get Trodelvy to earlier lines of care. But he stopped short of putting an exact timeline of when that might happen.
“At the end of the day, we recognize that patients can’t wait, and we’re moving toward this very clinically,” Abidoye told Endpoints. “But we’d expect over the course of the next year that we’d start to have some of that information.”
One of the ways Gilead is trying to get the drug into earlier treatment settings is through combination approaches with checkpoint inhibitors. The biopharma is currently conducting some early studies internally and with academic centers to figure out the best path forward.
“Being able to provide Trodelvy to patients but also see access in earlier settings is important to Gilead,” Abidoye said “It’s really important that we’re able to show this is an effective and tolerable medication, and I think the quality of life data shows that.”
Thursday’s data come from the Phase III ASCENT study that ultimately got Trodelvy across the FDA finish line, a study that’s provided a steady trickle of subgroup analyses in the months since approval. Researchers measured the results using a questionnaire asking patients how they perceive their own physical, mental and social health.
Questions were asked on the first day of each 21-day treatment cycle for up to six cycles and at the end of treatment.
Among the group of 419 total patients, the 236 who were in the drug arm showed significant and clinically meaningful improvements across the board. Trodelvy patients saw improvements in global health status (p<0.05), physical functioning p<0.01) and emotional functioning (p<0.05), compared to those who received SoC of physician’s chemotherapy choice.
Gilead also said it observed significant improvements in symptomatic impact of fatigue (p<0.05), pain (p<0.01), difficulty breathing (p<0.01) and insomnia (p<0.05). The only measure that didn’t hit the mark was diarrhea, where Trodelvy registered as significantly worse than standard of care.
That result, however, didn’t translate into a negative impact on patients’ global health score or functioning, the biopharma said. When regulators approved Trodelvy, they slapped a black box warning on the drug for severe diarrhea as well as severe or life-threatening low white blood cell count, specifically neutrophils.
Gilead released this sub-analysis in tag-team fashion with new survival data from the Phase III trial as well, noting improved progression-free survival, overall survival and objective response rate in patients who were not initially diagnosed with TNBC. That release came from a group of 146 patients who originally received a breast cancer diagnosis that was not TNBC.
The biopharma is trying to build out datasets in earlier lines of therapy to stay ahead of AstraZeneca and Daiichi Sankyo, who continue to push forward their own TROP-2 antibody-drug conjugate in datopotamab deruxtecan. Those partners read out their most recent data back from a Phase I study in May, reporting a 43% response rate and five confirmed complete or partial responses among 21 patients with TNBC.
This article has been updated to include comment from Gilead head of oncology Daejin Abidoye.