Xiaolin Zhang, PhD, discusses findings from the phase 2 study exploring a novel oral agent for the treatment of EGFR-mutated non–small cell lung cancer.
The pivotal phase 2 WU-KONG1 study (NCT03974022) is investigating sunvozertinib (DZD9008) for its effectiveness in treating non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutatations.
Findings showed that in patients who were previously treated with chemotherapy, sunvozertinib shrank tumors in over half of the patients (54.3%). Responses were seen across various patient groups, including those with brain tumors. Treatment-emergent adverse effects were manageable, with diarrhea, rash, and muscle enzyme increase being the most common.
This is promising initial data, and the study is ongoing to confirm the long-term benefits and safety of sunvozertinib.
Here, Xiaolin Zhang, PhD, discusses the agent and findings from the study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Transcription:
0:05 | Globally, there's no single-agent small molecule approved yet. And a couple months ago, the [Johnson & Johnson] bispecific antibod, the EGFR cMet bispecific antibody was approved in the first line in combination with 2 chemo doublet. In the second line, the [Johnson & Johnson] antibody is now approved because of first-line approval is automatically converted to second-line, the bispecific antibody as a second-line treatment.
0:02 | Compared to the [Johnson & Johnson] antibody, there are clear advantages for our agent. A, it is a single agent, an oral agent. And in the second line, our results, our ORR, which is the primary end point, is a little bit over 50 and some of them, about 46 of them are confirmed. There are a few percentage of that, they have the first assessment that needs to be confirmed because we need longer time to follow up.
1:06 | And also we have a great duration of response. The DOR, it looks very good. It not mature. The 9-month, at the data cut-off, the 9-month duration of response is still close to 60%. We estimate it probably will be 12 months and over, which is fantastic. So second-line, efficacy-wise, we clearly have an advantage.
1:26 | In terms of safety, it is an oral single agent, and the AEs we have found from part B are very consistent with WU-KONG6 [NCT05668988] we have reported previously. The diarrhea increased a few percentage and partly reflect [that this] is a global study. And we have different regions, they have different levels of experience to manage that AE. Still, that is a very tolerable agent, because it's a single agent, oral, you don't need IV, you don't have any IV-related injection site adverse effects. And you don't have to combine with the chemo, because once you have to combine with chemo, there are a lot of issues. This is the second line.
2:07 | In the he first line where our our study is, we already have well into it. Now we are aiming to to complete the study for the end of the year, early next year, recruitment. At [the European Society for Medical Oncology Annual Congress] last year, we reported our preliminary results. ORR is 71.4%, which is fantastic. And the [progression-free survival (PFS)] we estimated will be 12.4 months, which is also very competitive. Again, it is a single agent, a single origin. We don't to combine with chemo doublet, so that is the great benefit to our patients.
Transcription created with AI and edited for clarity.