Celgene Corporation (CELG) today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (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 (TNBC), a type of breast cancer with high unmet need.
Results demonstrated that the investigational combination of TECENTRIQ®(atezolizumab) plus ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) compared to ABRAXANE® monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat (ITT) 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.
“The IMpassion130 results are extremely encouraging for patients with this highly aggressive form of breast cancer for which there are limited options,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “This is the third positive Phase III study to demonstrate a clinical benefit with TECENTRIQ® plus ABRAXANE® as part of a treatment regimen; the other studies evaluated this investigational combination in non-small cell lung cancer patients. These data demonstrate the potential role of ABRAXANE®as a preferred chemotherapy partner for immunotherapy combinations.”
Results will be presented at an upcoming medical meeting.
ABRAXANE® is not approved in combination with TECENTRIQ® for any indication in any geography.
About the IMpassion130 Study
IMpassion130 is a Phase III multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ® and ABRAXANE® compared with placebo in combination with ABRAXANE® in people with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomized equally (1:1). The co-primary endpoints were progression-free survival (PFS) per investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants [intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
During the treatment duration, people in:
- Arm A received TECENTRIQ® at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle and ABRAXANE® at a dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. ABRAXANE® was administered for a target of at least 6 cycles, with no maximum. Participants received both agents until unacceptable toxicity or disease progression.
- Arm B received ABRAXANE® at a dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. ABRAXANE® was administered for a target of at least 6 cycles, with no maximum, and placebo was administered via IV infusion on Days 1 and 15 of each 28-day cycle. Participants received both agents until unacceptable toxicity or disease progression.
About Triple Negative Breast Cancer
Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.
TECENTRIQ® is a registered trademark of Genentech, a member of the Roche Group.
ABRAXANE is indicated for the treatment of 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.
ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.