Protara Therapeutics' TARA-002 has demonstrated promising results in a Phase II ADVANCED-2 trial for non-muscle invasive bladder cancer (NMIBC). The data, which represents a six-month update, reveals a significant complete response rate (CRR), particularly in patients with carcinoma in situ (CIS) who are unresponsive to Bacillus Calmette-Guérin (BCG) treatment.
High Complete Response Rates Observed
The trial data indicates that TARA-002 achieved an 80% CRR at any time point. Notably, in the BCG-unresponsive cohort with CIS only, the CRR reached 100% at six months. This efficacy is based on a small sample size, with the 80% CRR observed in four out of five patients and the 100% CRR at six months in four out of four patients in the CIS-only BCG-unresponsive cohort.
Analyst Optimism and Market Position
TD Cowen maintained a Buy rating and a $50.00 price target for Protara Therapeutics (NASDAQ:TARA) following the release of these results. The analyst highlighted the compelling efficacy, especially considering the small number of patients in the trial and the clean safety profile of TARA-002. Protara's market capitalization stands at $140.7 million, and the company holds more cash than debt on its balance sheet, indicating a strong financial position.
Competitive Efficacy in NMIBC Treatment Landscape
The observed efficacy of TARA-002 appears competitive when compared to other agents in development for NMIBC. These agents have reported approximately 70-75%+ CRR at any time and about 50-60%+ CRR at six months. A subset of CIS-only patients in these trials has shown roughly 70-80% CRR, while concomitant CIS and papillary patients have shown 20-30% CRR.
Considerations and Future Outlook
While the sample size is small and CIS-only patients may be easier to treat, the analyst expressed optimism regarding the update. The efficacy surpasses the key opinion leader (KOL) efficacy benchmark of 30-50% CRR at six months, which is considered before proceeding to cystectomy, a surgical procedure to remove the bladder. The FDA has granted Fast Track designation to Protara's investigational therapy, Intravenous (IV) Choline Chloride, aimed at treating patients requiring parenteral support.
