BCC 2021 | ABP 980, a trastuzumab biosimilar in combination with pertuzumab
Hans-Christian Kolberg, MD, Marien Hospital Bottrop, Bottrop, Germany, discusses evidence of the use of ABP 980, a trastuzumab biosimilar, in patients with HER2+ breast cancer. ABP 980 is approved in the U.S based on extrapolation of data from the LILAC trial, a randomized, double-blind, active-controlled study (NCT01901146) investigating the safety of ABP 980 in women with HER2+ early breast cancer. Results discussed by Dr Kolberg highlight the synergistic activity of ABP 980 which is found to be comparable to that of trastuzumab in combination with pertuzumab and with pertuzumab and docetaxel. This interview took place during the 17th St. Gallen International Breast Cancer Conference.
Transcript (edited for clarity)
As you’ve mentioned, ABP 980 is a trastuzumab biosimilar that is approved in the US and the European Union and is approved for early breast cancer, for metastatic breast cancer, if they’re HER2-positive, and metastatic gastric cancer, if it is HER2-positive. As you can see from that approval, and from the fact that actually, the standard in HER2-positive early breast cancer in the neoadjuvant setting is, one of the standards is, dual blockade in combination with pertuzumab...
As you’ve mentioned, ABP 980 is a trastuzumab biosimilar that is approved in the US and the European Union and is approved for early breast cancer, for metastatic breast cancer, if they’re HER2-positive, and metastatic gastric cancer, if it is HER2-positive. As you can see from that approval, and from the fact that actually, the standard in HER2-positive early breast cancer in the neoadjuvant setting is, one of the standards is, dual blockade in combination with pertuzumab. We all know that we will have to combine that drug, that ABP 980, or other trastuzumab biosimilars with pertuzumab, although we don’t really have at the moment clinical data regarding that. The fact that this is possible is because the approval for biosimilars includes the extrapolation. So that means we only have one approval study, a registration trial, that was the LILAC trial, where we used chemotherapy in combination with ABP 980, compared to the originator trastuzumab in neoadjuvant setting of early breast cancer. That led to the approval.
But reality has changed since the study was designed. And actually, dual blockade is the standard. That is in our opinion, possible after this approval. But of course, we want to increase confidence that this is possible. One of the facts that will lead to that confidence is a clinical trial, the GeparX trial, where dual blockade was in Germany and from the German Breast Group where the dual blockade was conducted in combination of ABP 980 and pertuzumab.
But we also need what we call in the biosimilars world, the totality of evidence approach. And that is why we conducted this investigation where we used a breast cancer cell line and we treated that breast cancer cell line with trastuzumab originator in combination with pertuzumab and docetaxel or with the combination of ABP 980 and pertuzumab and docetaxel. And we investigated different endpoints of response to that. And in all these endpoints, we saw actually the same response in that breast cancer cell line to both therapies, which means that in that preclinical study, we could demonstrate that the combination of pertuzumab is yielding the same preclinical results and that is something that is increasing confidence in that use also in clinical practice.
Read more...
