Celgene announces IMpassion130 study meets co-primary endpoint of PFS
Celgene (CELG) announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival, or PFS.
This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer, or TNBC, a type of breast cancer with high unmet need.
Results demonstrated that the investigational combination of Tecentriq plus Abraxane compared to Abraxane monotherapy, as an initial treatment, significantly reduced the risk of disease worsening or death in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat and PD-L1 positive populations.
Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.
Safety in the Tecentriq plus Abraxane arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
ABRAXANE is a microtubule inhibitor indicated for the treatment of:
Metastatic breast cancer, after failure of combination chemotherapy
for metastatic disease or relapse within 6 months of adjuvant
chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated.
• Locally advanced or metastatic non-small cell lung cancer (NSCLC),
as first-line treatment in combination with carboplatin, in patients who
are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in
combination with gemcitabine.
TECENTRIQ is a prescription medicine used to treat:
A type of bladder and urinary tract cancer called urothelial carcinoma.
- TECENTRIQ may be used when your bladder cancer:
- has spread or cannot be removed by surgery, and
- you are not able to take chemotherapy that contains a medicine called cisplatin, or
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
CELG closed at $83.85.
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