#ASCO21: Gilead's Trodelvy reads out new subgroup data showing benefit in earlier-line TNBC patients
With AstraZeneca and Daiichi sniffing at its trail, Gilead has worked hard to hold an advantage for ADC Trodelvy in particularly hard-to-treat breast cancer patients. Now, the drugmaker is reading out more late-stage data showing some benefit in earlier-line patients, and it could help carve a path forward to a bigger market share.
Gilead’s Trodelvy extended survival in a subgroup analysis of relapsed or refractory triple-negative breast cancer patients in the second line, a positive sign Gilead hopes could spell earlier lines of therapy for its TROP2-directed ADC, according to data from the Phase III ASCENT study set to be presented at this weekend’s #ASCO21.
Trodelvy received a full approval from the FDA in April to treat metastatic TNBC patients in the second line or later as well as an accelerated nod in urothelial carcinoma the same month.
In second-line patients who reported disease progression within 12 months of (neo)adjuvant chemo. Trodelvy cut the risk of disease worsening or death by 59% over chemo with a PFS of 5.7 months compared with 1.5 months on chemo. The therapy also posted a median OS of 10.9 months compared with 4.9 months for patients on chemo.
Trodelvy also showed a higher overall response rate compared with chemo — 30% compared with 3% — and a safety profile in the subgroup that was consistent with other studies, Gilead said. There were no treatment-related deaths in the subgroup.
Reading out in earlier lines of therapy will be a major focus point for Gilead as it looks to build its lead over AstraZeneca and Daiichi Sankyo, which are looking for approval for a TROP2-directed ADC of their own.
In early May, the partners read out Phase I cohort data for their next-gen ADC datopotamab deruxtecan showing a 43% response rate and five confirmed complete or partial responses among 21 patients with TNBC. The vast majority of those patients were treated with 6-mg doses of the drug while two received an 8-mg high dose. On top of the five confirmed responses, the partners were awaiting confirmation on four additional responses at the Jan. 8 cutoff date. Datopotamab posted a disease control rate of 95%.
Gilead won a full approval for Trodelvy in TNBC based on the strength of ASCENT, which showed Trodelvy reduced the risk of death in TNBC patients by 49%, with a median OS of 11.8 months, as opposed to the 6.9 months achieved by standard single-agent chemotherapy. PFS came in at a median of 4.8 months, compared to 1.7 months on chemotherapy.