New data from Protara Therapeutics and CG Oncology highlight the potential of their respective investigational therapies for non-muscle invasive bladder cancer (NMIBC). The findings, presented at the Society of Urologic Oncology annual meeting, showcase encouraging efficacy outcomes and favorable safety profiles for TARA-002 and cretostimogene grenadenorepvec.
TARA-002 Demonstrates High Complete Response Rates
Protara Therapeutics presented Phase II results for TARA-002, an investigational cell therapy designed to activate innate and adaptive immune responses within the bladder tumor microenvironment. The study revealed a 72% complete response (CR) rate across 18 evaluable patients at six months, irrespective of prior Bacillus Calmette-Guérin (BCG) immunotherapy, the current standard treatment for bladder cancer. Notably, in the subgroup of four BCG-unresponsive patients, TARA-002 achieved a 100% CR rate at six months. This is particularly significant as this cohort is designed to be registrational, according to Protara.
In BCG-naïve patients, TARA-002 showed a CR rate of 64% at six months. The therapy also demonstrated a favorable safety profile, with no treatment-related adverse events of grade 2 or higher and no discontinuations due to toxicities. Initial 12-month data from the trial are expected by mid-2025.
Cretostimogene Grenadenorepvec Shows Durable Responses
CG Oncology released Phase III data for cretostimogene grenadenorepvec, an oncolytic immunotherapy designed to selectively replicate in cells with a defective retinoblastoma gene pathway. This replication leads to cancer cell lysis and the subsequent attraction of immune mediators, triggering an antitumor immune response.
The BOND-003 trial demonstrated a 74.5% CR rate in BCG-unresponsive patients treated with cretostimogene grenadenorepvec. The median duration of response had not been reached at the time of the readout but exceeded 27 months as of September 30. Similar to TARA-002, cretostimogene grenadenorepvec was well-tolerated, with no treatment-related adverse events of grade 3 or higher and no discontinuations due to side effects.
Implications for Bladder Cancer Treatment
These results suggest that both TARA-002 and cretostimogene grenadenorepvec could offer valuable treatment options for patients with NMIBC, particularly those who are unresponsive to BCG therapy. The dual mechanism of action of cretostimogene grenadenorepvec differentiates it from current and investigational NMIBC treatments, potentially addressing an unmet need for bladder-sparing therapeutics. If approved by the FDA, cretostimogene grenadenorepvec is well positioned to address an unmet need for patients as a potential backbone bladder-sparing therapeutic.
