Context Therapeutics (NASDAQ:CNTX) Inc has highlighted encouraging clinical responses from its Phase 2 OATH clinical trial evaluating ONA-XR to treat endometrial cancer.
The company said that two patients achieved a confirmed partial response among the first 12 patients (9 evaluable) enrolled in the Phase 2 OATH clinical trial evaluating the potential of Context’s oral progesterone receptor antagonist onapristone extended release in combination with anastrozole to treat hormone receptor-positive metastatic endometrial cancer.
“Data from the ongoing Phase 2 OATH clinical trial supports the potential for ONA-XR plus ANA combination therapy to serve as an effective therapeutic option in metastatic EC. We are encouraged by these findings and look forward to continued enrollment in the trial,” said Martin Lehr, CEO of Context Therapeutics in a statement.
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Preliminary data from the ongoing Phase 2 OATH clinical trial evaluating the combination of ONA-XR with ANA in HR+ EC found that ONA-XR plus ANA demonstrated a 4-month progression-free survival rate of 77% and an overall response rate of 22%. These results suggest that ONA-XR plus ANA exhibits favorable efficacy and tolerability relative to historical data that evaluated physician’s choice of chemotherapy versus Lenvima plus Keytruda combination therapy in a similar treatment setting of metastatic endometrial cancer, the company said.
Metastatic endometrial cancer is an aggressive cancer of the uterus that is the fourth leading cause of cancer-related mortality in women and results in approximately 13,000 deaths per year in the United States.
Clinician and patient feedback indicates a high unmet need for a novel orally administered therapeutic that provides toxic therapy-like efficacy but with fewer debilitating side effects. Grade 3 or higher adverse events with standard EC therapies include diarrhea, nausea, vomiting, and hypertension.
Updated data regarding the Phase 2 OATH trial is expected to be provided in the second quarter 2023, the company added.
ONA-XR (onapristone extended release) is an oral, twice-a-day, selective progesterone receptor (PR) antagonist designed to block both ligand-dependent and ligand-independent activity of PR, the company said.
Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting PR binding to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion. In addition to the Phase 2 OATH clinical trial evaluating the combination of ONA-XR and anastrozole to treat endometrial cancer, ONA-XR is also being studied in other Phase 2 clinical trials, including two breast cancer trials in combination with selective estrogen receptor degraders.
Context Therapeutics is a clinical-stage biopharmaceutical company committed to advancing medicines for solid tumors, with a primary focus on female cancers.
Contact the author at jon.hopkins@proactiveinvestors.com