The pivotal part 2 WU-KONG1 research (NCT03974022) is investigating sunvozertinib (DZD9008) for its effectiveness in treating non–small cell lung most cancers (NSCLC) with EGFR exon 20 insertion mutatations.
Findings confirmed that in sufferers who have been beforehand handled with chemotherapy, sunvozertinib shrank tumors in over half of the sufferers (54.3%). Responses have been seen throughout numerous affected person teams, together with these with mind tumors. Remedy-emergent opposed results have been manageable, with diarrhea, rash, and muscle enzyme improve being the commonest.
That is promising preliminary information, and the research is ongoing to substantiate the long-term advantages and security of sunvozertinib.
Right here, Xiaolin Zhang, PhD, discusses the agent and findings from the research on the 2024 American Society of Medical Oncology (ASCO) Annual Assembly.
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0:05 | Globally, there is no single-agent small molecule permitted but. And a pair months in the past, the [Johnson & Johnson] bispecific antibod, the EGFR cMet bispecific antibody was permitted within the first line together with 2 chemo doublet. Within the second line, the [Johnson & Johnson] antibody is now permitted due to first-line approval is mechanically transformed to second-line, the bispecific antibody as a second-line remedy.
0:02 | In comparison with the [Johnson & Johnson] antibody, there are clear benefits for our agent. A, it’s a single agent, an oral agent. And within the second line, our outcomes, our ORR, which is the first finish level, is slightly bit over 50 and a few of them, about 46 of them are confirmed. There are just a few proportion of that, they’ve the primary evaluation that must be confirmed as a result of we want longer time to comply with up.
1:06 | And in addition we’ve an important period of response. The DOR, it appears superb. It not mature. The 9-month, on the information cut-off, the 9-month period of response continues to be near 60%. We estimate it in all probability will probably be 12 months and over, which is improbable. So second-line, efficacy-wise, we clearly have a bonus.
1:26 | When it comes to security, it’s an oral single agent, and the AEs we’ve discovered from half B are very in keeping with WU-KONG6 [NCT05668988] we’ve reported beforehand. The diarrhea elevated just a few proportion and partly replicate [that this] is a world research. And we’ve completely different areas, they’ve completely different ranges of expertise to handle that AE. Nonetheless, that could be a very tolerable agent, as a result of it is a single agent, oral, you do not want IV, you have no IV-related injection web site opposed results. And you do not have to mix with the chemo, as a result of as soon as you need to mix with chemo, there are a variety of points. That is the second line.
2:07 | Within the he first line the place our our research is, we have already got effectively into it. Now we’re aiming to to finish the research for the top of the yr, early subsequent yr, recruitment. At [the European Society for Medical Oncology Annual Congress] final yr, we reported our preliminary outcomes. ORR is 71.4%, which is improbable. And the [progression-free survival (PFS)] we estimated will probably be 12.4 months, which can also be very aggressive. Once more, it’s a single agent, a single origin. We do not to mix with chemo doublet, so that’s the nice profit to our sufferers.
