Patients with early triple-negative breast cancer had improved outcomes with the addition of durvalumab (Imfinzi) to anthracycline and taxane-based chemotherapy as neoadjuvant therapy, according to a trial presented at the virtual .
In this exclusive ľֱ video, , of MD Anderson Cancer Center in Houston, offers her takeaways from the .
Following is a transcript of her remarks:
GeparNUEVO was a study of 174 patients who received nab-paclitaxel and durvalumab followed by anthracycline-based chemotherapy with epirubicin and durvalumab, and then went to surgery. And it already presented, just like the IMpassion031 and the KEYNOTE-522 [trials], showing some improvement in pCR [pathologic complete response]. And, that had been 44.2% to 53.4% improvement. And what this did was actually looked at median followup at 43.7 months and showed that question that everyone's asking for the use of immunotherapy -- what about longer-term survival?
The 3-year invasive disease-free survival improved from 77.2% to 85.6%, the distant disease-free [survival] from 78.4% to 91.7%. And they're seeing a separation in the overall survival, from 83.5% to 95.2%. And I think that this comes into a lot of the questions that we really have around endpoints for preoperative chemotherapy or preoperative systemic therapy trials. What is the Delta in [pCR] that matters? And I think that this also shows us that when we're thinking about immunotherapy, the Delta and pCR isn't the whole story. And seeing that a bigger separation that we're seeing on the back end of it is something we're going to really need to think about as we're restructuring these trials for these endpoints.
I still am left with the same problem with triple-negative breast cancer, where so many of the people will do so well with a full [pCR] with very little. I hoped that this is the end of the days of, "Let's throw all the patients with triple-negative breast cancer in the same study with one drug." It's one of the reasons I do love I-SPY and other kind of platforms that try to individualize therapy here. Because I think that we could be minimizing a bigger effect for a group of people who really need this, and that we're certainly going to be exposing a lot of people to the long-term toxicity of immunotherapy that can be lifelong like the endocrinopathies, and they would have been cured completely with polychemotherapy alone, and maybe even less of that. So I think that we will absolutely, if the KEYNOTE [trial] is positive, we'll be doing it, but I really think we need to be more thoughtful of how we're going to figure out who really needs this or not.