Pfizer PFE and partner Arvinas ARVN reported interim data from a phase Ib cohort of the ARV-471-mBC-101 study evaluating the investigational combination of vepdegestrant (formerly ARV-471) and CDK4/6 inhibitor Ibrance (palbociclib) in certain patients with heavily pre-treated breast cancer.
At the time of data cutoff (i.e., Jun 6, 2023), the study cohort consisted of 46 patients who had received a median of four lines of therapy across disease settings with locally advanced or metastatic ER+/HER2- breast cancer.
Interim data from the phase Ib cohort demonstrated encouraging clinical activity in the heavily pre-treated study participants. Data from the study showed that treatment with the vepdegestrant-Ibrance combination achieved a clinical benefit rate (CBR) of 63%, with a median progression-free survival (PFS) of 11.1 months.
The study cohort also achieved an overall response rate (ORR) of 42% in certain evaluable patients whose disease was measurable at baseline. The safety profile of the combination therapy was also consistent with the safety profiles of individual drugs in previously conducted clinical studies.
Vepdegestrant is an investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor protein degrader developed using Arvinas’ proprietary technology to treat ER/HER2- breast cancer. Arvinas entered into a collaboration agreement with Pfizer in 2021 to develop and market this candidate jointly.
Pfizer’s shares have lost 43.2% year to date against the industry’s 5.4% growth.
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Currently, vepdegestrant is being evaluated in two late-stage studies — VERITAC-2 and VERITAC-3 — as a monotherapy in the second-line setting and in combination with Ibrance in the first-line setting.
Based on the positive clinical progress with the PROTAC degrader, Pfizer and Arvinas intend to evaluate vepdegestrant in combination with several CDK4/6 inhibitors in first-line and second-line settings. In this regard, the companies plan to start two late-stage studies — one on the vepdegestrant-Ibrance combo in the second-line setting and another on vepdegestrant combined with PF-07220060, Pfizer’s novel CDK4 inhibitor, in the first-line setting.
Pfizer’s Ibrance is one of the leading drugs approved for HR+, HER2- metastatic breast cancer, in combination with an aromatase inhibitor as the first hormonal-based therapy or fulvestrant in people with disease progression following hormonal therapy.
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Zacks Rank & Key Picks
Pfizer currently carries a Zacks Rank #3 (Hold). A couple of top-ranked stocks in the overall healthcare sector include CytomX Therapeutics CTMX and Novo Nordisk NVO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 2 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 6 cents. Shares of CytomX have lost 11.9% in the year-to-date period.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.07. Shares of NVO have surged 47.2% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
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