Pfizer’s Tukysa (tucatinib) has enhanced patient outcomes when used as a maintenance therapy during a late-stage trial in breast cancer.
The oral tyrosine kinase inhibitor (TKI), which was evaluated alongside first-line standard of care (SoC) treatments trastuzumab and pertuzumab, met its primary endpoint – offering statistically significant improvements to progression-free survival (PFS) versus placebo.
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Topline HER2CLIMB-05 trial (NCT05132582) results also demonstrated the tolerability of the Tukysa when administered in tandem with trastuzumab and pertuzumab, with the candidate’s safety profile mirroring those of each individual therapy.
The favourable efficacy and safety profile of Tukysa plus SoC maintenance was seen in patients with metastatic, human epidermal growth factor receptor 2 (HER2)-positive disease after undergoing a chemotherapy induction regimen.
Though Pfizer did not disclose further information on the study’s results, principal investigator and director of breast cancer research at the Sarah Cannon Research Institute, Erika Hamilton, noted that “the addition of Tukysa to first-line maintenance therapy may further lower the risk of disease progression or death”.
Moving forward, Pfizer will present results of the HER2CLIMB-05 trial at an unspecified medical conference. The New York-based pharma will also share these study outcomes with regulatory agencies.
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By GlobalDataBreast cancer treatment gets much-needed maintenance
Though there are effective treatments in the front-line maintenance setting for metastatic breast cancer, there have been no upgrades to the treatment paradigm since 2012.
Currently, the SoC primarily centres around the CLEOPATRA regimen, which combines trastuzumab and pertuzumab with chemotherapy agent docetaxel.
However, pharma companies are now looking to remove non-targeted and aggressive treatments such as docetaxel from the maintenance setting, which has seen drugs like Tukysa enter the clinic.
Pfizer acquired the rights to Tukysa through its $43bn acquisition of Seagen Therapeutics in 2023.
If Pfizer’s TKI were to get the US Food and Drug Administration (FDA) green light in first-line breast cancer, it would mark a shift away from chemotherapy in the maintenance setting, potentially improving patient quality of life.
In a 14 September statement, Pfizer’s chief oncology development officer, Johanna Bendell, noted that the positive HER2CLIMB-05 results, as well as Tukysa’s established safety profile in later lines, could mark its potential to “play a meaningful role in front-line maintenance”.
Bendell also noted that Tukysa’s approval would allow the drug to reach a wider range of patients with HER2-positive disease, which could have a significant impact on overall sales for the drug.
This is reflected in a consensus forecast from analysts at GlobalData, who predict that Tukysa will become a blockbuster drug for Pfizer by 2028. GlobalData is the parent company of Clinical Trials Arena.
Pfizer’s drug is not the only one seeking glory in this setting, as AstraZeneca and Daiichi Sankyo are currently seeking FDA approval for their blockbuster antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan).
This follows the positive results of the DESTINY-Breast09 trial, which saw the drug bolster PFS when used alongside pertuzumab as a post-chemotherapy maintenance treatment.
A consensus forecast from analysts at GlobalData estimates that Enhertu will become a megablockbuster by 2029, raking in $10.7bn across all approved indications.
