The Orascovery Programs served as the main focus of Athenex’s clinical development efforts up until 2021. After receiving a Complete Response Letter from U.S. FDA, we decided not to pursue the metastatic breast cancer indication in the U.S. In March 2022, we also announced discontinuation of other oral programs in combination with encequidar. There are only two ongoing Oral paclitaxel trials that could potentially unlock value that are ongoing, and require relatively limited investment by Athenex.
The first of these is the I-SPY 2 trial which has an expected readout in the second half of 2022. This study is run by the Quantum Leap Healthcare Collaborative, which has been using our drug in two of its study arms in combination with dostarlimab +/- carboplatin in breast cancer patients in the neoadjuvant setting. This is a randomized, Phase 2 trial that could advance into Phase 3 and beyond if results are encouraging and is an area of value that could be unlocked.
The second trial is the Phase 1/2 clinical trial of Oral Paclitaxel in combination with pembrolizumab in patients with non-small cell lung cancer, which recently initiated the expansion phase. We have so far reported highly encouraging data of 4 partial responses and 4 stable diseases in 8 evaluable patients at ESMO 2021.
These studies will remain ongoing, and we will look for opportunities to extract further value from this asset through potential partnerships or other means.
Additionally, the UK Medicines and Healthcare Products Regulatory Agency validated our Marketing Authorization Application for Oral Paclitaxel for the treatment of advanced breast cancer, and we will provide an update when more information becomes available.
