Modra Pharmaceuticals announced positive data from its Phase IIb trial evaluating its boosted oral taxane therapeutic, ModraDoc006/r, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to the standard-of-care, the IV chemotherapy docetaxel. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent which enhances bioavailability. In a total of 101 patients enrolled, ModraDoc006/r demonstrated a similar efficacy and an improved tolerability profile compared to IV docetaxel, with reduced neutropenia, neuropathy and alopecia. The trial data will be presented at the 2022 Annual American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) held from February 17-19, 2022.
Out of the total study population, 49 patients received IV docetaxel and 52 ModraDoc006/r (21 on 30-20/200-100 mg (“30-20”) and 31 on 20-20/200-100 mg (“20-20”) bi-daily weekly dosing (BIDW) doses). ModraDoc006/r vs IV docetaxel demonstrated an overall response rate (ORR) of 44% vs. 39%, respectively. Prostate-Specific Antigen (PSA) responses were comparable at 50% vs. 57%, respectively. Neutropenia (low levels of neutrophils, a type of white blood cell) was eliminated with ModraDoc006/r at the 20-20 mg dose, reduced to 14% at the 30-20 mg dose vs 25% on IV docetaxel. Neuropathy (nerve damage or dysfunction) and alopecia were also reduced with ModraDoc006/r at the 20-20 mg dose compared to the 30-20 mg dose and IV docetaxel. Gastrointestinal toxicities were slightly more frequent, but still predominantly mild, in the ModraDoc006/r arm at both dose levels.