Medicine Matters oncology

Hello. It's my pleasure to talk about the ASCENT study on behalf of the co-authors. This was presented at Virtual ESMO 2020, a randomized Phase 3 trial of sacituzumab govitecan versus treatment of physician's choice for patients with previously pretreated metastatic triple-negative breast cancer. This was a large global Phase 3 trial that compared sacituzumab govitecan, which is a novel antibody-drug conjugate that targets Trop-2, versus standard chemotherapy for patients with metastatic triple-negative breast cancer. The primary endpoint of the study was progression-free survival.

The study was positive. It showed that patients who received sacituzumab govitecan had a better progression-free survival as compared to standard chemotherapy, with a hazard ratio of 0.41. And this was highly statistically significant, with a p-value of less than 0.0001. Median PFS in patients who received sacituzumab govitecan was 5.6 months as compared to 1.7 months with standard chemotherapy.

We also looked at overall survival, and, again, you can see that patients who received sacituzumab govitecan had a much better overall survival as compared to standard chemotherapy, with a hazard ratio of 0.48. And this was highly statistically significant, with a p-value of less than 0.0001. The median overall survival was 12.1 months with sacituzumab govitecan as compared to 6.7 months with standard chemotherapy. So these results confirm that sacituzumab govitecan should be considered the new standard of care for patients with pretreated metastatic triple-negative breast cancer.

This was in the third-line and plus setting and this reflects the FDA approval as well, so the plan is to bring it to earlier lines-- first line, second line metastatic triple-negative breast cancer, and even earlier, as neoadjuvant and adjuvant therapy for patients with triple-negative breast cancer. So that's one future direction. The second is combination with other agents-- immunotherapy, PARP inhibitors-- to further improve the outcomes that we're seeing with this agent as a single agent.

And the third direction is to look at this agent in other subtypes of breast cancers, such as hormone-receptor-positive breast cancer. TROPiCS-02 is currently ongoing. That's looking at sacituzumab govitecan versus standard chemotherapy for hormone-receptor-positive metastatic breast cancer.

But because Trop-2 is also expressed in hormone receptor-positive breast cancer, conceptually, this agent could work in that setting. In the Phase 1/Phase 2 trial, we did see efficacy of this agent in patients with hormone-receptor-positive breast cancer. The manuscript just got published a couple weeks ago in Annals of Oncology, so the idea now is to see if we can have this agent for our patients with hormone-receptor-positive breast cancer as well.