After Protara Therapeutics, Inc. (NASDAQ: TARA) revealed encouraging results from its current Phase 2 ADVANCED-2 study, its shares jumped sharply, increasing more than 103% to $7.20.
The study evaluates TARA-002, an experimental cell-based treatment, for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC) in patients with carcinoma in situ (CIS), especially those who are BCG-naïve or resistant to Bacillus Calmette-Guérin (BCG).
Significant Findings in High-Risk NMIBC Patients
The ADVANCED-2 trial came up with encouraging results. Across all BCG exposures, the study found that the complete response (CR) rate was 70% at any given time and 72% after six months.
Notably, 100% of patients who achieved a CR maintained this response from three to six months, and two of three patients sustained the CR at nine months. These findings demonstrate a substantial level of activity in a patient group that has limited treatment options.
Details of the ADVANCED-2 Trial Cohorts
With a data cutoff date of November 19, 2024, the trial’s dataset comprises 20 patients who can be evaluated at three months, 18 patients who can be evaluated at six months, and three patients who can be evaluated at nine months.
The promise of TARA-002 in this difficult category was demonstrated by the pivotal cohort of BCG-unresponsive patients, who showed a CR rate of 100% at six months and 80% at any time. Meanwhile, in the BCG-naïve cohort, the CR rate was 64% at six months and 67% at any point during the trial.
An Option for Safe and Efficient Treatment
In addition, TARA-002 has shown a great safety and tolerability profile; no treatment-related adverse events (TRAEs) of Grade 2 or higher have been documented. Furthermore, no individuals discontinued taking the medicine due to adverse effects, indicating that it might be a well-tolerated option for people with NMIBC.
These encouraging results not only demonstrate TARA-002’s efficacy in treating challenging NMIBC patients, but they also establish it as a strong therapeutic choice for doctors. Protara’s international site expansion is expected to accelerate patient enrollment, with initial 12-month data expected by mid-2025.
