Initial preliminary efficacy and safety data are expected sometime next year, stated Aditya Bardia, MBBS, MPH, breast medical oncologist, Massachusetts General Hospital, Harvard Medical School.
Initial preliminary efficacy and safety data are expected sometime next year, followed by dose expansion and a phase 2 trial, explained Aditya Bardia, MBBS, MPH, breast medical oncologist, Massachusetts General Hospital, Harvard Medical School.
What is the timeline for the phase 1B portion of the ASCENT trial investigating sacituzumab govitecan (SG) and talazoparib?
It is still ongoing. And we hope to have at least preliminary efficacy and safety tolerability data early next year, and then after that, the trial would expand to dose expansion as well as a phase 2 trial to further confirm the efficacy and safety tolerability. But in terms of initial preliminary data, sometime next year we should have those results.
Is there a timeline for the phase 1B portion?
In part that would depend on the efficacy of the data, how robust the results look, and that would help guide for the development of phase 2 or even phase 3.
Have additional patient safety measures been implemented with flu season and the coronavirus disease 2019 (COVID-19) pandemic overlapping?
Oh, it started absolutely in March of 2020 when Boston got hit with COVID-19. The institutions in the Boston region, including MGH, implemented a number of procedures to ensure that patients with cancer are safe, and those measures remain in place. We've not seen nosocomial or hospitals spread of COVID-19. And despite the pandemic, the clinical trial with SG plus [a] PARP inhibitor continued to enroll, and we had patients enrolled even when the pandemic was at its peak.
In Boston, we’ve not seen any COVID infection in patients who were treated with this agent, in part because of the preventive measures that have been instituted at our institution. One thing to consider is that neither SG nor [a] PARP inhibitor necessarily would increase the risk of either flu or COVID. But we know that triple-negative breast cancer is an aggressive disease, so it’s important to control the disease while ensuring that we take whatever precautions are needed.
We actually wrote a report about this as a CPC, or clinical pathological conference, in the New England Journal of Medicine that was published in July, talking about a patient with breast cancer during the COVID pandemic and how it could have an impact. And the bottom line was, we have to weigh the risks and benefits and take whatever precautions are needed, but at the same time, ensure that the anticancer treatment or the care of patient with breast cancer is not compromised.