Arvinas and Pfizer Announce Results from Phase 3 VERITAC-2 Trial:
Arvinas, Inc., a clinical-stage biotechnology company focused on developing small molecule therapeutics based on its proprietary PROTAC (Proteolysis-Targeting Chimera) technology, and Pfizer Inc., an international pharmaceutical company, have recently announced topline results from the Phase 3 VERITAS-2 trial. This trial evaluated vepdegestrant monotherapy versus fulvestrant in adult patients with advanced or metastatic breast cancer.
Background:
Breast cancer is the most common cancer among women worldwide. Approximately 20% of breast cancer cases are considered hormone receptor-positive (HR+), HER2-negative (HER2-), and metastatic. Fulvestrant is a selective estrogen receptor degrader (SERD) that is currently approved for the treatment of HR+, HER2- metastatic breast cancer. Vepdegestrant is a next-generation, oral, selective estrogen receptor degrader (SERD) designed to provide continuous suppression of the estrogen receptor (ER) with a favorable pharmacokinetic and pharmacodynamic profile.
Trial Results:
The double-blind, randomized, placebo-controlled Phase 3 trial enrolled 572 patients with HR+, HER2-, advanced or metastatic breast cancer. The primary endpoint was progression-free survival (PFS). The trial met its primary endpoint, demonstrating a statistically significant improvement in PFS for patients treated with vepdegestrant compared to those treated with fulvestrant (hazard ratio = 0.74 [95% CI: 0.61-0.90], p = 0.003).
Additional Findings:
Key secondary endpoints included objective response rate (ORR) and safety. The ORR was 24.2% (95% CI: 19.2-30.2) for vepdegestrant and 15.4% (95% CI: 11.1-20.3) for fulvestrant. The most common adverse events (AEs) for vepdegestrant were gastrointestinal (GI) AEs (nausea, diarrhea, and vomiting) and hot flashes. The most common AEs for fulvestrant were arthralgia and back pain.
Implications for Patients:
These results suggest that vepdegestrant may provide a more effective treatment option for patients with HR+, HER2-, advanced or metastatic breast cancer compared to fulvestrant. However, it is important to note that these are topline results and further analysis is needed to fully understand the implications for patients. Consulting with a healthcare professional is recommended for those considering treatment options.
Implications for the World:
The successful completion of the Phase 3 VERITAS-2 trial represents a significant step forward in the development of next-generation SERDs for the treatment of HR+, HER2- advanced or metastatic breast cancer. The results of this trial may lead to the approval of vepdegestrant as a new treatment option for this patient population. Furthermore, the use of PROTAC technology in the development of vepdegestrant and other potential therapeutics has the potential to revolutionize the way we approach the treatment of various diseases.
Conclusion:
The Phase 3 VERITAS-2 trial results demonstrate a statistically significant improvement in progression-free survival for patients treated with vepdegestrant compared to fulvestrant in the treatment of HR+, HER2- advanced or metastatic breast cancer. These findings suggest that vepdegestrant may provide a more effective treatment option for patients, although further analysis is needed. The successful completion of this trial also represents a significant step forward in the development of next-generation SERDs and the use of PROTAC technology in the treatment of various diseases.
- Arvinas, Inc. and Pfizer announce topline results from Phase 3 VERITAS-2 trial
- Vepdegestrant demonstrates statistically significant improvement in PFS compared to fulvestrant
- Next-generation SERDs may provide more effective treatment options for HR+, HER2- advanced or metastatic breast cancer
- PROTAC technology has the potential to revolutionize the way we approach disease treatment
