Arvinas and Pfizer’s Vepdegestrant improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Arvinas and Pfizer have announced their new detailed results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase 4/6 inhibitors and endocrine therapy.

“Many patients with ER+/HER2- metastatic breast cancer who progress on endocrine therapy have tumors with ESR1 mutations, which drive resistance to standard treatments,” said Erika P. Hamilton, M.D., Director, Breast Cancer Research, Sarah Cannon Research Institute, and a principal investigator of the VERITAC-2 trial. “The VERITAC-2 results are promising and suggest that vepdegestrant could offer a much-needed treatment option for these patients, with a low incidence of burdensome GI effects that can meaningfully affect daily life.”

Vepdegestrant was generally well tolerated in the trial, with a safety profile consistent with what has been observed in previous studies, and mostly low-grade treatment-emergent adverse events. Rates and severity of gastrointestinal adverse events were low with vepdegestrant. Grade 4 TEAEs were reported in 5 patients in the vepdegestrant arm versus 9 patients in the fulvestrant arm. The three most common TEAEs observed with vepdegestrant were fatigue, increased alanine transaminase and increased aspartate aminotransferase.

“Based on these strong data from VERITAC-2, we believe that vepdegestrant has the potential to be a best-in-class monotherapy treatment for patients in the second-line ESR1-mutant setting,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “We are excited to engage with regulatory authorities on next steps to potentially bring vepdegestrant to healthcare providers and their patients as swiftly as possible.”

“Patients whose tumors harbor ESR1 mutations can face a poor prognosis, often experiencing rapid disease progression on endocrine therapy,” said Johanna Bendell, M.D., Chief Oncology Development Officer, Pfizer. “These results highlight the important role vepdegestrant may play in combating ESR1 mutation treatment resistance for these patients.”

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Related Topics and Keywords

Arvinas, breast cancer, ER+/HER2- Advanced Breast Cancer, her 2, Pfizer, SR1-Mutant