Arvinas and Pfizer Phase 1b Data from TACTIVE-U Sub-Study

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Arvinas and Pfizer recently shared promising preliminary data from their ongoing Phase 1b trial of vepdegestrant in combination with abemaciclib for patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. So far, the results look pretty encouraging.

In this study, 16 patients who were previously treated with a CDK4/6 inhibitor were given a combo of abemaciclib and vepdegestrant. The good news is that the treatment appeared to be safe and well-tolerated. That’s always a positive sign when developing new therapies!

The data showed a clinical benefit rate of 62.5% among patients with both mutant ESR1 and wild-type ESR1 disease. This means that over half of the patients saw some benefit from the treatment. Moreover, there was no significant interaction between vepdegestrant and abemaciclib, and no major impact on the amount of abemaciclib in the body.

Based on these promising results, the researchers have identified the recommended Phase 2 dose of vepdegestrant and abemaciclib for further evaluation. The Phase 2 study will focus on evaluating the full dose of abemaciclib in combination with vepdegestrant for advanced breast cancer patients who have previously received CDK4/6 inhibitors.

Both Arvinas and Pfizer are excited about the potential of vepdegestrant. They believe this new therapy could be a game-changer for patients with ER+ metastatic breast cancer. The ongoing TACTIVE-U clinical trial is exploring various combinations of vepdegestrant with other drugs to find the best treatment options for these patients.

It’s worth mentioning that vepdegestrant was granted Fast Track designation by the FDA as a potential monotherapy for adults with ER+/HER2- locally advanced or metastatic breast cancer who have been treated with endocrine-based therapy. This highlights the importance and urgency of developing new treatment options for patients in need.

Overall, these initial results look promising, and we’re eager to see how this research progresses. Stay tuned for more updates as the study continues to unfold!

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