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NEW YORK - Pfizer Inc. (NYSE:PFE), a prominent pharmaceutical company with a market capitalization of $140.6 billion and currently trading at an attractive valuation according to InvestingPro analysis, announced Tuesday that its Phase 3 HER2CLIMB-05 trial for TUKYSA (tucatinib) met its primary endpoint in patients with HER2-positive metastatic breast cancer.
The study evaluated TUKYSA versus placebo, both combined with standard maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction in first-line treatment. Results showed a statistically significant and clinically meaningful improvement in progression-free survival in patients receiving the TUKYSA combination compared to placebo. This development comes as Pfizer maintains strong financial fundamentals with a robust gross profit margin of 73.8% and trailing twelve-month revenue of $63.8 billion.
The safety profile was reported to be generally consistent with established profiles of each individual therapy, according to the company’s press release statement.
HER2-positive breast cancer affects approximately 15-20% of breast cancer patients and is associated with poor prognosis. The five-year survival rate for metastatic HER2-positive breast cancer ranges from 41-47%.
"The HER2CLIMB-05 results demonstrate that the addition of TUKYSA to first-line maintenance therapy may further lower the risk of disease progression or death, with a treatment that has a well-established safety profile," said Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Director of Breast Cancer Research at Sarah Cannon Research Institute.
TUKYSA is currently approved in more than 50 countries for later-line treatment of HER2-positive metastatic breast cancer. In the United States, it is approved for use in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
The company plans to present detailed results at a future medical congress and discuss them with regulatory authorities.
The HER2CLIMB-05 trial included 654 participants who completed induction therapy without disease progression, with 326 receiving TUKYSA with trastuzumab plus pertuzumab and 328 receiving placebo with trastuzumab plus pertuzumab.
In other recent news, Pfizer has declared a fourth-quarter dividend of $0.43 per share, payable on December 1, 2025, to shareholders of record as of November 7, 2025. Guggenheim has reiterated its Buy rating on Pfizer stock, setting a price target of $33.00 ahead of the company’s third-quarter 2025 earnings report. The firm forecasts Pfizer’s Q3 revenues to be around $15.7 billion, which is below the Visible Alpha Consensus estimate of $17.2 billion, with projected earnings per share of $0.58 compared to a consensus expectation of $0.72. Meanwhile, BMO Capital has reiterated an Outperform rating with a $30.00 price target following Pfizer’s recent deal with Metsera, highlighting the company’s strategic move into the obesity metabolic space. Additionally, Pfizer plans to present research from 46 abstracts across its infectious disease portfolio at IDWeek 2025 in Atlanta, covering diseases such as COVID-19 and RSV. Lastly, President Donald Trump is expected to announce a U.S. drug pricing deal at the White House. These developments indicate active strategic movements and upcoming financial disclosures for Pfizer.
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