Study to evaluate paclitaxel plus encequidar with dostarlimab +/- carboplatin in patients with breast cancer.
Quantum Leap Healthcare has partnered with Athenex, Inc to determine the efficacy of combining oral paclitaxel plus encequidar with GlaxoSmithKline’s (GSK) dostarlimab +/- carboplatin in patients with stage 2/3 human epidermal growth factor receptor 2 (HER2)-negative breast cancer, as well plus trastuzumab followed, if needed, by doxorubicin plus cyclophosphamide chemotherapy (AC) and surgical resection of breast tissue in patients who are HER2-positive.
The primary endpoint of the study will assess objective response rates as measured by pathologic complete response, to be taken at the end of therapy during a pathological assessment of residual disease. Secondary endpoints will include a safety assessment.
The trial is a randomized, controlled multicenter platform study. Participants were diagnosed with high-risk, locally advanced breast cancer with a high likelihood of recurrence. Patients either receive the combination along with doxorubicin plus cyclophosphamide chemotherapy or neoadjuvant chemotherapy alone. Participants also receive surgical resection of breast tissue if needed.
“We’re very excited to enter this treatment combination into the trial,” said Laura Esserman, MD, the lead investigator for the I-SPY 2 study, in a press release. “We believe Athenex’s oral paclitaxel combined with encequidar will be much easier for patients, may be more tolerable, and in combination, improve the chance of complete response, which is our goal. We are looking to test combinations that have greater efficacy and less toxicity. Importantly, I-SPY 2 allows us to determine which combinations work best for patients based on tumor biology. The change to an oral taxane backbone is a very important step to reducing toxicity for all patients.”
GSK will provide the dostarlimab and Athenex will provide the oral paclitaxel and encequidar. The study will be run by Quantum Leap.
Quantum Leap Healthcare Collaborative and Athenex Announce the Selection of Oral Paclitaxel plus Encequidar in Combination with dostarlimab, an anti-PD-1, in the I-SPY 2 TRIAL targeting Stage 2/3 HER2+ and HER2- Breast Cancers [News Release] September 8, 2020; Buffalo, NY. https://ir.athenex.com/news-releases/news-release-details/quantum-leap-healthcare-collaborative-and-athenex-announce. Accessed November 2, 2020